Myocardial ProtectionPhase 4ADENOCARDIONCT07426237
Effect of the Addition of Adenosine on Myocardial Protection During Cardiopulmonary Bypass
A Phase 4 study testing Adenoseine in people with Myocardial Protection, run by Hospital Nossa Senhora da Conceicao at 1 site in Brazil.
Trial summary
The goal of this clinical trial is to evaluate whether the addition of adenosine to standard cardioplegia improves myocardial protection in adult patients undergoing on-pump cardiac surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Protection
- What is being tested?
- Adenoseine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- 30 Mar 2026to 1 Jul 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients aged 18 years or older undergoing elective isolated valve replacement or coronary artery bypass grafting with cardiopulmonary bypass at Hospital Nossa Senhora da Conceição, Porto Alegre
Who cannot join
- Previous cardiac surgery;
- Chronic kidney disease (serum creatinine greater than 2.0 mg/dL);
- Severe psychiatric illness;
- Urgent or emergency surgery;
- Multiple cardiac procedures.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site
Hospital Nossa Senhora da Conceição
Porto Alegre, Rio Grande do Sul, 91350-200
Felipe Abatti Spadini, MD, MSc, +555133572000, felipespadini@gmail.com
Adriana Silveira Almeida, PhD, +555133572000, adrianasdealmeida@gmail.com
About this study
Official title: Effect of the Addition of Adenosine on Myocardial Protection During Cardiopulmonary Bypass: A Double-Blind Randomized Clinical Trial
The goal of this clinical trial is to evaluate whether the addition of adenosine to standard cardioplegia improves myocardial protection in adult patients undergoing on-pump cardiac surgery. The study population includes adult patients of both sexes undergoing elective cardiac procedures requiring cardiopulmonary bypass and cardioplegic arrest.
The main questions this trial aims to answer are:
Read more
Does the addition of adenosine to cardioplegia affect myocardial protection as assessed by transesophageal echocardiography (TEE)?
What is the effect of adenosine on biochemical markers of myocardial injury, such as postoperative high-sensitivity troponin levels?
What is the effect of adenosine on perioperative hemodynamic support requirements, as quantified by the Vasoactive-Inotropic Score (VIS)?
Researchers will compare patients receiving adenosine-supplemented cardioplegia with those receiving standard cardioplegia (placebo) to assess differences in echocardiographic indicators of myocardial protection, biomarker release, and need for vasoactive/inotropic support.
Participants will:
Receive either adenosine-supplemented cardioplegia (adenosine 1.2 mmol/L; 24 mg) or placebo according to randomization.
Undergo standard perioperative monitoring during cardiac surgery.
Undergo intraoperative transesophageal echocardiography (TEE) to evaluate myocardial protection by comparing pre- and post-cardiopulmonary bypass (CPB) measurements.
Have postoperative laboratory testing for high-sensitivity troponin at baseline, 2h, 12h, and 24h after clamp release.
Have hemodynamic support requirements recorded and VIS calculated at the end of surgery and at 12h and 24h postoperatively.
Be followed for perioperative clinical outcomes including arrhythmias, need for cardioversion or mechanical circulatory support, ICU/hospital length of stay, myocardial infarction, and mortality.
Read the detailed description
Myocardial ischemia-reperfusion injury remains a key contributor to postoperative myocardial dysfunction and adverse outcomes in patients undergoing cardiac surgery with cardiopulmonary bypass (CPB). Despite refinements in cardioplegic solutions and perfusion strategies, biochemical evidence of myocardial injury and transient or persistent ventricular dysfunction remain common, particularly among older patients and those with preexisting ventricular impairment. These observations underscore the ongoing need for adjunctive strategies that enhance myocardial protection during both the ischemic arrest and early reperfusion phases.
Adenosine is an endogenous purine nucleoside with pleiotropic cardioprotective properties, including negative chronotropic and dromotropic effects, coronary vasodilation, attenuation of calcium influx, and modulation of inflammatory and endothelial pathways. Experimental data and small clinical studies suggest that adenosine administration at the onset of ischemia or during early reperfusion may reduce ischemia-reperfusion injury by facilitating rapid electrical arrest, limiting intracellular calcium overload, improving microvascular perfusion, and attenuating inflammatory activation. However, the optimal timing, dosing strategy, and clinical relevance of adenosine administration as an adjunct to modern cardioplegia in routine adult cardiac surgery remain incompletely defined.
This prospective, randomized, double-blind, placebo-controlled, parallel-group trial is designed to evaluate whether a single bolus of adenosine administered immediately after aortic cross-clamping and immediately before infusion of standard del Nido cardioplegia improves myocardial protection in adult patients undergoing elective coronary artery bypass grafting and/or valve surgery with CPB. Following cross-clamp application, patients allocated to the intervention group will receive adenosine at a concentration of 1.2 mmol/L (total dose 24 mg) delivered into the aortic root, while control patients will receive an equivalent volume of sterile water. Thereafter, cardioplegia delivery and all subsequent intraoperative management will proceed according to institutional standards, ensuring that the only protocolized difference between groups is the administration of adenosine or placebo.
Randomization will be performed using permuted blocks to ensure balanced group allocation. Blinding will be maintained for patients, surgeons, anesthesiologists, perfusionists, investigators, outcome assessors, and data analysts throughout the study period. Anesthesia management, CPB strategy, myocardial protection techniques, and postoperative care will follow standardized institutional protocols to minimize confounding.
The extent of myocardial injury will be assessed primarily through serial measurements of high-sensitivity cardiac troponin T obtained preoperatively and at predefined intervals following aortic cross-clamp removal. Hemodynamic support requirements will be quantified using the vasoactive-inotropic score (VIS), providing an integrated assessment of postoperative circulatory support needs. In addition to biochemical and hemodynamic endpoints, myocardial protection will be directly evaluated using transesophageal echocardiography (TEE). Comprehensive TEE examinations will be performed immediately before initiation of CPB and again after successful weaning from CPB, allowing for paired assessment of global and regional ventricular function, wall motion abnormalities, and overall myocardial performance in the immediate reperfusion period.
Secondary clinical observations will include intraoperative rhythm disturbances, need for electrical cardioversion or defibrillation, postoperative ventricular function, requirements for mechanical circulatory support, incidence of postoperative atrial fibrillation, length of intensive care unit and hospital stay, perioperative myocardial infarction, and mortality.
Safety monitoring will be conducted throughout the trial. Given the ultra-short half-life of adenosine and its extensive use in clinical cardiology, adverse effects are expected to be transient and self-limited, most commonly brief atrioventricular conduction disturbances or asystole occurring immediately after administration. These effects are anticipated to resolve spontaneously within seconds in the controlled operative setting. All adverse events will be recorded and reviewed according to predefined safety protocols.
By integrating biochemical markers, echocardiographic assessment, and clinical outcomes, this trial aims to provide a comprehensive evaluation of adenosine as an adjunct to conventional cardioplegia. The findings may help clarify its role in mitigating ischemia-reperfusion injury and inform future myocardial protection strategies in adult cardiac surgery.
- Conditions
- Myocardial Protection
- Being tested
- Adenoseine, Placebo (sterile distilled water)
- Keywords
- myocardial protection, cardioplegia, del Nido
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdenoseineDrug
Participants randomized to the adenosine group will receive a single bolus of adenosine 1.2 mmol/L (24 mg) administered directly into the aortic root immediately after aortic cross-clamping and immediately before infusion of standard del Nido cardioplegia. The solution will be prepared by the perfusionist under sterile conditions.
Placebo (sterile distilled water)Drug
Participants randomized to the placebo group will receive a single bolus of sterile distilled water, matched in volume and appearance to the adenosine solution, administered into the aortic root immediately after aortic cross-clamping and immediately prior to infusion of standard del Nido cardioplegia. The solution will be prepared by the perfusionist under sterile conditions to ensure identical volume and appearance to the placebo solution. Perioperative and postoperative management will be identical to the intervention group.
| Study group | Role | What they receive |
|---|---|---|
| Adenosine | Active comparator | Not described Receives: Drug: Adenoseine |
| Sterile Distilled Water | Placebo comparator | Not described Receives: Drug: Placebo (sterile distilled water) |
What is being measured
The primary outcome is the main question the study is designed to answer.
High-sensitivity troponin
Measured: baseline (upon entry to the operating room) and at 2, 12, and 24 hours after aortic cross-clamp release
Vasoactive-Inotropic Score (VIS)
The VIS will be calculated based on the administration of vasoactive drugs using the formula described by Gaies: VIS = (dopamine µg/kg/min) + (dobutamine µg/kg/min) + (epinephrine µg/kg/min × 100) + (norepinephrine µg/kg/min × 100) + (milrinone µg/kg/min × 10) + (vasopressin units/kg/min × 10,000).
Measured: Immediately after completion of surgery and at 12 and 24 hours after aortic cross-clamp release
TEE assessment of myocardial protection
by transesophageal echocardiography (TEE)
Measured: The first measurement will be done at the day of the surgery in the operating room befere skin incision and the second one will be done whitin 1 hour after separation from cardiopulmonary bypass
Secondary outcomes (14)
Arrhythmias requiring cardioversion or defibrillation
Measured: Perioperative
Need for temporary pacing
Requirement for temporary pacing due to atrioventricular block or bradyarrhythmias
Measured: Periprocedural
New-onset atrial fibrillation
New atrial fibrillation assessed by electrocardiography
Measured: Day 1
Use of mechanical circulatory support
The necessity of ECMO (Extracorporeal Membrane Oxygenation)
Measured: Perioperative period (during hospitalization after surgery)
Mortality
Measured: Perioperative period (during hospitalization after surgery)
New ischemic stroke
Confirmed by cranial computed tomography (CT) or magnetic resonance imaging (MRI)
Measured: Perioperative period (during hospitalization after surgery)
Acute myocardial infarction
Defined according to current guidelines for post-cardiac surgery myocardial infarction (Type 5 myocardial infarction), as defined by the Fourth Universal Definition of Myocardial Infarction: a postoperative cardiac troponin elevation >10 times the 99th percentile upper reference limit (or a >20% rise from an elevated baseline with an absolute value >10× the 99th percentile), in addition to at least one of the following: new pathological Q waves or left bundle branch block, angiographically documented new graft or native coronary artery occlusion, or imaging evidence of new loss of viable myocardium or new regional wall motion abnormality consistent with ischemia.
Measured: Perioperative period (during hospitalization after surgery)
Arterial blood gas parameters
Measurement of arterial blood gas variables obtained from arterial blood samples, including: pH (unitless), PaO₂ (mmHg), PaCO₂ (mmHg), HCO₃- (mmol/L), Base excess (mmol/L)
Measured: On the day of surgery and at 12 and 24 hours after aortic cross-clamp release
Complete blood count
Laboratory assessment of complete blood count obtained from arterial blood samples, including: hemoglobin [g/dL], hematocrit [%], leukocyte count [×10⁹/L], platelet count [×10⁹/L]
Measured: On the day of surgery and at 12 and 24 hours after aortic cross-clamp release
Serum lactate level
Measurement of lactate concentration (mmol/L) obtained from arterial blood samples.
Measured: On the day of surgery and at 12 and 24 hours after aortic cross-clamp release
C-reactive protein
Measurement of C-reactive protein level (mg/L) obtained from arterial blood samples.
Measured: On the day of surgery and at 12 and 24 hours after aortic cross-clamp release
Blood glucose
Measurement of blood glucose level (mg/dL) obtained from arterial blood samples.
Measured: On the day of surgery and at 12 and 24 hours after aortic cross-clamp release
Serum electrolyte concentrations
Measurement of electrolyte concentrations obtained from arterial blood samples, including: Sodium (mmol/L), Potassium (mmol/L), Chloride (mmol/L)
Measured: On the day of surgery and at 12 and 24 hours after aortic cross-clamp release
Blood lactate dehydrogenase concentration
Measurement of lactate dehydrogenase (LDH) concentration (U/L) obtained from arterial blood samples through laboratory analysis.
Measured: On the day of surgery and at 12 and 24 hours after aortic cross-clamp release
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start30 Mar 2026 (estimated)
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Myocardial ProtectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Nossa Senhora da Conceicao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07426237
- Sponsor's protocol ID
- 7.975.821
- Acronym
- ADENOCARDIO
- Status last verified
- Jan 2026
- First submitted
- 18 Nov 2025
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual data will be used
Publications
Allen BS. Myocardial protection: a forgotten modality. Eur J Cardiothorac Surg. 2020 Feb 1;57(2):263-270. doi: 10.1093/ejcts/ezz215.
PubMed 31364690Singh A, Huang X, Dai L, Wyler D, Alfirevic A, Blackstone EH, Pettersson GB, Duncan AE. Right ventricular function is reduced during cardiac surgery independent of procedural characteristics, reoperative status, or pericardiotomy. J Thorac Cardiovasc Surg. 2020 Apr;159(4):1430-1438.e4. doi: 10.1016/j.jtcvs.2019.04.035. Epub 2019 Apr 26.
PubMed 31133354Lira KB, Delvaux RS, Spadini FA, Hauschild LH, Ceron RO, Anschau F, Kopittke L, Rode J, Rey RAW, Wittke EI, Rombaldi AR, Cambruzzi E, Lopes ERC, Almeida AS. Myocardial protection: comparing histological effects of single-dose cardioplegic solutions-study protocol for a secondary analysis of the CARDIOPLEGIA trial. J Thorac Dis. 2024 Feb 29;16(2):1480-1487. doi: 10.21037/jtd-23-1442. Epub 2024 Feb 20.
PubMed 38505015Almeida AS, Ceron RO, Anschau F, Kopittke L, Lira KB, Delvaux RS, Rode J, Rey RAW, Wittke EI, Rombaldi AR. Comparison between Custodiol, del Nido and modified del Nido in the myocardial protection - Cardioplegia Trial: a study protocol for a randomised, double-blind clinical trial. BMJ Open. 2021 Sep 6;11(9):e047942. doi: 10.1136/bmjopen-2020-047942.
PubMed 34489276Ammar A, Mahmoud K, Elkersh A, Kasemy Z. A Randomized Controlled Trial of Intra-Aortic Adenosine Infusion Before Release of the Aortic Cross-Clamp During Coronary Artery Bypass Surgery. J Cardiothorac Vasc Anesth. 2018 Dec;32(6):2520-2527. doi: 10.1053/j.jvca.2017.10.041. Epub 2017 Dec 8.
PubMed 29225152Abdelwahab AA, Sabry M, Elshora HA, Arafat AA. Effect of Fast Cardioplegic Arrest Induced by Adenosine on Cardiac Troponin Levels After Heart Valve Surgery. Heart Lung Circ. 2019 Nov;28(11):1714-1719. doi: 10.1016/j.hlc.2018.08.017. Epub 2018 Sep 12.
PubMed 30253969Jakobsen O, Naesheim T, Aas KN, Sorlie D, Steensrud T. Adenosine instead of supranormal potassium in cardioplegia: it is safe, efficient, and reduces the incidence of postoperative atrial fibrillation. A randomized clinical trial. J Thorac Cardiovasc Surg. 2013 Mar;145(3):812-8. doi: 10.1016/j.jtcvs.2012.07.058. Epub 2012 Sep 7.
PubMed 22964356Mentzer RM Jr, Birjiniuk V, Khuri S, Lowe JE, Rahko PS, Weisel RD, Wellons HA, Barker ML, Lasley RD. Adenosine myocardial protection: preliminary results of a phase II clinical trial. Ann Surg. 1999 May;229(5):643-9; discussion 649-50. doi: 10.1097/00000658-199905000-00006.
PubMed 10235522Wei M, Kuukasjarvi P, Laurikka J, Honkonen EL, Kaukinen S, Laine S, Tarkka M. Cardioprotective effect of adenosine pretreatment in coronary artery bypass grafting. Chest. 2001 Sep;120(3):860-5. doi: 10.1378/chest.120.3.860.
PubMed 11555521Jakobsen O, Muller S, Aarsaether E, Steensrud T, Sorlie DG. Adenosine instead of supranormal potassium in cardioplegic solution improves cardioprotection. Eur J Cardiothorac Surg. 2007 Sep;32(3):493-500. doi: 10.1016/j.ejcts.2007.05.020. Epub 2007 Jul 5.
PubMed 17613242Francica A, Tonelli F, Rossetti C, Tropea I, Luciani GB, Faggian G, Dobson GP, Onorati F. Cardioplegia between Evolution and Revolution: From Depolarized to Polarized Cardiac Arrest in Adult Cardiac Surgery. J Clin Med. 2021 Sep 29;10(19):4485. doi: 10.3390/jcm10194485.
PubMed 34640503Vinten-Johansen J, Zhao ZQ, Corvera JS, Morris CD, Budde JM, Thourani VH, Guyton RA. Adenosine in myocardial protection in on-pump and off-pump cardiac surgery. Ann Thorac Surg. 2003 Feb;75(2):S691-9. doi: 10.1016/s0003-4975(02)04694-5.
PubMed 12607714Jovanovic A, Lopez JR, Alekseev AE, Shen WK, Terzic A. Adenosine prevents K+-induced Ca2+ loading: insight into cardioprotection during cardioplegia. Ann Thorac Surg. 1998 Feb;65(2):586-91. doi: 10.1016/s0003-4975(97)01240-x.
PubMed 9485282Dobson GP, Letson HL. Adenosine, lidocaine, and Mg2+ (ALM): From cardiac surgery to combat casualty care--Teaching old drugs new tricks. J Trauma Acute Care Surg. 2016 Jan;80(1):135-45. doi: 10.1097/TA.0000000000000881.
PubMed 26683400
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Addition of Adenosine on Myocardial Protection During Cardiopulmonary Bypass: A Double-Blind Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07426237
- Acronym / sponsor ID
- ADENOCARDIO / 7.975.821
- Conditions
- Myocardial Protection
- Keywords
- myocardial protection, cardioplegia, del Nido
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hospital Nossa Senhora da ConceicaoUniversity, hospital or other
- Study start
- 30 Mar 2026 (estimated)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 23 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to evaluate whether the addition of adenosine to standard cardioplegia improves myocardial protection in adult patients undergoing on-pump cardiac surgery. The study population includes adult patients of both sexes undergoing elective cardiac procedures requiring cardiopulmonary bypass and cardioplegic arrest.
The main questions this trial aims to answer are:
Does the addition of adenosine to cardioplegia affect myocardial protection as assessed by transesophageal echocardiography (TEE)?
What is the effect of adenosine on biochemical markers of myocardial injury, such as postoperative high-sensitivity troponin levels?
What is the effect of adenosine on perioperative hemodynamic support requirements, as quantified by the Vasoactive-Inotropic Score (VIS)?
Researchers will compare patients receiving adenosine-supplemented cardioplegia with those receiving standard cardioplegia (placebo) to assess differences in echocardiographic indicators of myocardial protection, biomarker release, and need for vasoactive/inotropic support.
Participants will:
Receive either adenosine-supplemented cardioplegia (adenosine 1.2 mmol/L; 24 mg) or placebo according to randomization.
Undergo standard perioperative monitoring during cardiac surgery.
Undergo intraoperative transesophageal echocardiography (TEE) to evaluate myocardial protection by comparing pre- and post-cardiopulmonary bypass (CPB) measurements.
Have postoperative laboratory testing for high-sensitivity troponin at baseline, 2h, 12h, and 24h after clamp release.
Have hemodynamic support requirements recorded and VIS calculated at the end of surgery and at 12h and 24h postoperatively.
Be followed for perioperative clinical outcomes including arrhythmias, need for cardioversion or mechanical circulatory support, ICU/hospital length of stay, myocardial infarction, and mortality.
Detailed description
Myocardial ischemia-reperfusion injury remains a key contributor to postoperative myocardial dysfunction and adverse outcomes in patients undergoing cardiac surgery with cardiopulmonary bypass (CPB). Despite refinements in cardioplegic solutions and perfusion strategies, biochemical evidence of myocardial injury and transient or persistent ventricular dysfunction remain common, particularly among older patients and those with preexisting ventricular impairment. These observations underscore the ongoing need for adjunctive strategies that enhance myocardial protection during both the ischemic arrest and early reperfusion phases.
Adenosine is an endogenous purine nucleoside with pleiotropic cardioprotective properties, including negative chronotropic and dromotropic effects, coronary vasodilation, attenuation of calcium influx, and modulation of inflammatory and endothelial pathways. Experimental data and small clinical studies suggest that adenosine administration at the onset of ischemia or during early reperfusion may reduce ischemia-reperfusion injury by facilitating rapid electrical arrest, limiting intracellular calcium overload, improving microvascular perfusion, and attenuating inflammatory activation. However, the optimal timing, dosing strategy, and clinical relevance of adenosine administration as an adjunct to modern cardioplegia in routine adult cardiac surgery remain incompletely defined.
This prospective, randomized, double-blind, placebo-controlled, parallel-group trial is designed to evaluate whether a single bolus of adenosine administered immediately after aortic cross-clamping and immediately before infusion of standard del Nido cardioplegia improves myocardial protection in adult patients undergoing elective coronary artery bypass grafting and/or valve surgery with CPB. Following cross-clamp application, patients allocated to the intervention group will receive adenosine at a concentration of 1.2 mmol/L (total dose 24 mg) delivered into the aortic root, while control patients will receive an equivalent volume of sterile water. Thereafter, cardioplegia delivery and all subsequent intraoperative management will proceed according to institutional standards, ensuring that the only protocolized difference between groups is the administration of adenosine or placebo.
Randomization will be performed using permuted blocks to ensure balanced group allocation. Blinding will be maintained for patients, surgeons, anesthesiologists, perfusionists, investigators, outcome assessors, and data analysts throughout the study period. Anesthesia management, CPB strategy, myocardial protection techniques, and postoperative care will follow standardized institutional protocols to minimize confounding.
The extent of myocardial injury will be assessed primarily through serial measurements of high-sensitivity cardiac troponin T obtained preoperatively and at predefined intervals following aortic cross-clamp removal. Hemodynamic support requirements will be quantified using the vasoactive-inotropic score (VIS), providing an integrated assessment of postoperative circulatory support needs. In addition to biochemical and hemodynamic endpoints, myocardial protection will be directly evaluated using transesophageal echocardiography (TEE). Comprehensive TEE examinations will be performed immediately before initiation of CPB and again after successful weaning from CPB, allowing for paired assessment of global and regional ventricular function, wall motion abnormalities, and overall myocardial performance in the immediate reperfusion period.
Secondary clinical observations will include intraoperative rhythm disturbances, need for electrical cardioversion or defibrillation, postoperative ventricular function, requirements for mechanical circulatory support, incidence of postoperative atrial fibrillation, length of intensive care unit and hospital stay, perioperative myocardial infarction, and mortality.
Safety monitoring will be conducted throughout the trial. Given the ultra-short half-life of adenosine and its extensive use in clinical cardiology, adverse effects are expected to be transient and self-limited, most commonly brief atrioventricular conduction disturbances or asystole occurring immediately after administration. These effects are anticipated to resolve spontaneously within seconds in the controlled operative setting. All adverse events will be recorded and reviewed according to predefined safety protocols.
By integrating biochemical markers, echocardiographic assessment, and clinical outcomes, this trial aims to provide a comprehensive evaluation of adenosine as an adjunct to conventional cardioplegia. The findings may help clarify its role in mitigating ischemia-reperfusion injury and inform future myocardial protection strategies in adult cardiac surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adenosine | Active comparator | Drug: Adenoseine |
| Sterile Distilled Water | Placebo comparator | Drug: Placebo (sterile distilled water) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients aged 18 years or older undergoing elective isolated valve replacement or coronary artery bypass grafting with cardiopulmonary bypass at Hospital Nossa Senhora da Conceição, Porto Alegre
Key exclusion criteria (5 listed)
- Previous cardiac surgery;
- Chronic kidney disease (serum creatinine greater than 2.0 mg/dL);
- Severe psychiatric illness;
- Urgent or emergency surgery;
- Multiple cardiac procedures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AdenoseineParticipants randomized to the adenosine group will receive a single bolus of adenosine 1.2 mmol/L (24 mg) administered directly into the aortic root immediately after aortic cross-clamping and immediately before infusion of standard del Nido cardioplegia. The solution will be prepared by the perfusionist under sterile conditions. | Drug | Adenosine |
| Placebo (sterile distilled water)Participants randomized to the placebo group will receive a single bolus of sterile distilled water, matched in volume and appearance to the adenosine solution, administered into the aortic root immediately after aortic cross-clamping and immediately prior to infusion of standard del Nido cardioplegia. The solution will be prepared by the perfusionist under sterile conditions to ensure identical volume and appearance to the placebo solution. Perioperative and postoperative management will be identical to the intervention group. | Drug | Sterile Distilled Water |
Primary outcome
High-sensitivity troponin
Time frame: baseline (upon entry to the operating room) and at 2, 12, and 24 hours after aortic cross-clamp release
Vasoactive-Inotropic Score (VIS)
Time frame: Immediately after completion of surgery and at 12 and 24 hours after aortic cross-clamp release
The VIS will be calculated based on the administration of vasoactive drugs using the formula described by Gaies: VIS = (dopamine µg/kg/min) + (dobutamine µg/kg/min) + (epinephrine µg/kg/min × 100) + (norepinephrine µg/kg/min × 100) + (milrinone µg/kg/min × 10) + (vasopressin units/kg/min × 10,000).
TEE assessment of myocardial protection
Time frame: The first measurement will be done at the day of the surgery in the operating room befere skin incision and the second one will be done whitin 1 hour after separation from cardiopulmonary bypass
by transesophageal echocardiography (TEE)
14 secondary outcomes
Arrhythmias requiring cardioversion or defibrillation
Time frame: Perioperative
Need for temporary pacing
Time frame: Periprocedural
New-onset atrial fibrillation
Time frame: Day 1
Use of mechanical circulatory support
Time frame: Perioperative period (during hospitalization after surgery)
Mortality
Time frame: Perioperative period (during hospitalization after surgery)
New ischemic stroke
Time frame: Perioperative period (during hospitalization after surgery)
Acute myocardial infarction
Time frame: Perioperative period (during hospitalization after surgery)
Arterial blood gas parameters
Time frame: On the day of surgery and at 12 and 24 hours after aortic cross-clamp release
Complete blood count
Time frame: On the day of surgery and at 12 and 24 hours after aortic cross-clamp release
Serum lactate level
Time frame: On the day of surgery and at 12 and 24 hours after aortic cross-clamp release
C-reactive protein
Time frame: On the day of surgery and at 12 and 24 hours after aortic cross-clamp release
Blood glucose
Time frame: On the day of surgery and at 12 and 24 hours after aortic cross-clamp release
Serum electrolyte concentrations
Time frame: On the day of surgery and at 12 and 24 hours after aortic cross-clamp release
Blood lactate dehydrogenase concentration
Time frame: On the day of surgery and at 12 and 24 hours after aortic cross-clamp release
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
- Results publication: PubMed 31364690Allen BS. Myocardial protection: a forgotten modality. Eur J Cardiothorac Surg. 2020 Feb 1;57(2):263-270. doi: 10.1093/ejcts/ezz215.
- Results publication: PubMed 31133354Singh A, Huang X, Dai L, Wyler D, Alfirevic A, Blackstone EH, Pettersson GB, Duncan AE. Right ventricular function is reduced during cardiac surgery independent of procedural characteristics, reoperative status, or pericardiotomy. J Thorac Cardiovasc Surg. 2020 Apr;159(4):1430-1438.e4. doi: 10.1016/j.jtcvs.2019.04.035. Epub 2019 Apr 26.
- Results publication: PubMed 38505015Lira KB, Delvaux RS, Spadini FA, Hauschild LH, Ceron RO, Anschau F, Kopittke L, Rode J, Rey RAW, Wittke EI, Rombaldi AR, Cambruzzi E, Lopes ERC, Almeida AS. Myocardial protection: comparing histological effects of single-dose cardioplegic solutions-study protocol for a secondary analysis of the CARDIOPLEGIA trial. J Thorac Dis. 2024 Feb 29;16(2):1480-1487. doi: 10.21037/jtd-23-1442. Epub 2024 Feb 20.
- Results publication: PubMed 34489276Almeida AS, Ceron RO, Anschau F, Kopittke L, Lira KB, Delvaux RS, Rode J, Rey RAW, Wittke EI, Rombaldi AR. Comparison between Custodiol, del Nido and modified del Nido in the myocardial protection - Cardioplegia Trial: a study protocol for a randomised, double-blind clinical trial. BMJ Open. 2021 Sep 6;11(9):e047942. doi: 10.1136/bmjopen-2020-047942.
- Results publication: PubMed 29225152Ammar A, Mahmoud K, Elkersh A, Kasemy Z. A Randomized Controlled Trial of Intra-Aortic Adenosine Infusion Before Release of the Aortic Cross-Clamp During Coronary Artery Bypass Surgery. J Cardiothorac Vasc Anesth. 2018 Dec;32(6):2520-2527. doi: 10.1053/j.jvca.2017.10.041. Epub 2017 Dec 8.
- Results publication: PubMed 30253969Abdelwahab AA, Sabry M, Elshora HA, Arafat AA. Effect of Fast Cardioplegic Arrest Induced by Adenosine on Cardiac Troponin Levels After Heart Valve Surgery. Heart Lung Circ. 2019 Nov;28(11):1714-1719. doi: 10.1016/j.hlc.2018.08.017. Epub 2018 Sep 12.
- Results publication: PubMed 22964356Jakobsen O, Naesheim T, Aas KN, Sorlie D, Steensrud T. Adenosine instead of supranormal potassium in cardioplegia: it is safe, efficient, and reduces the incidence of postoperative atrial fibrillation. A randomized clinical trial. J Thorac Cardiovasc Surg. 2013 Mar;145(3):812-8. doi: 10.1016/j.jtcvs.2012.07.058. Epub 2012 Sep 7.
- Results publication: PubMed 10235522Mentzer RM Jr, Birjiniuk V, Khuri S, Lowe JE, Rahko PS, Weisel RD, Wellons HA, Barker ML, Lasley RD. Adenosine myocardial protection: preliminary results of a phase II clinical trial. Ann Surg. 1999 May;229(5):643-9; discussion 649-50. doi: 10.1097/00000658-199905000-00006.
- Results publication: PubMed 11555521Wei M, Kuukasjarvi P, Laurikka J, Honkonen EL, Kaukinen S, Laine S, Tarkka M. Cardioprotective effect of adenosine pretreatment in coronary artery bypass grafting. Chest. 2001 Sep;120(3):860-5. doi: 10.1378/chest.120.3.860.
- Results publication: PubMed 17613242Jakobsen O, Muller S, Aarsaether E, Steensrud T, Sorlie DG. Adenosine instead of supranormal potassium in cardioplegic solution improves cardioprotection. Eur J Cardiothorac Surg. 2007 Sep;32(3):493-500. doi: 10.1016/j.ejcts.2007.05.020. Epub 2007 Jul 5.
- Results publication: PubMed 34640503Francica A, Tonelli F, Rossetti C, Tropea I, Luciani GB, Faggian G, Dobson GP, Onorati F. Cardioplegia between Evolution and Revolution: From Depolarized to Polarized Cardiac Arrest in Adult Cardiac Surgery. J Clin Med. 2021 Sep 29;10(19):4485. doi: 10.3390/jcm10194485.
- Results publication: PubMed 12607714Vinten-Johansen J, Zhao ZQ, Corvera JS, Morris CD, Budde JM, Thourani VH, Guyton RA. Adenosine in myocardial protection in on-pump and off-pump cardiac surgery. Ann Thorac Surg. 2003 Feb;75(2):S691-9. doi: 10.1016/s0003-4975(02)04694-5.
- Individual participant dataSharing planned: No. No individual data will be used
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Adenoseine in people with Myocardial Protection, run by Hospital Nossa Senhora da Conceicao at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Felipe Abatti Spadini, MD, MSc (+5554981181291, felipespadini@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
High-sensitivity troponin (time frame: baseline (upon entry to the operating room) and at 2, 12, and 24 hours after aortic cross-clamp release). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07426237, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2026.