Heart; Surgery, Heart, Functional Disturbance as ResultPhase 4NCT04094168
Clinical Impact of Del Nido Cardioplegia in Adult Cardiac Surgery
A Phase 4 study testing DEL NIDO CARDIOPLEGIA and COLD BLOOD BASED CARDIOPLEGIA in people with Heart; Surgery, Heart, Functional Disturbance as Result, run by JESSICA GARCIA SUAREZ at 1 site in Spain.
Trial summary
Cardioplegia solutions have been used for myocardial protection in cardiac surgery for decades. Different cardioplegic strategies have been evaluated. Del Nido cardioplegia was initially used in pediatric patients and has been expanding into adult cardiac centers over the last decade. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart; Surgery, Heart, Functional Disturbance as Result
- What is being tested?
- DEL NIDO CARDIOPLEGIA and COLD BLOOD BASED CARDIOPLEGIA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 474 participants
- Where
- 1 siteSpain
- Study dates
- 15 Jun 2018to 28 Feb 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- Patients age 18 years or older undergoing adult cardiac surgery.
- Elective surgical procedures requiring cardiopulmonary bypass and myocardial arrest.
Who cannot join
- Emergency surgery.
- Patients on preoperative inotropic support and/or mechanical circulatory support.
- Patient who refuse to participate in the study.
- Lidocaine allergy.
- Port access mitral valve surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Outcomes of Del Nido Cardioplegia in Adult Cardiac Surgery: a Randomized Controlled Trial
Cardioplegia solutions have been used for myocardial protection in cardiac surgery for decades. Different cardioplegic strategies have been evaluated.
Del Nido cardioplegia was initially used in pediatric patients and has been expanding into adult cardiac centers over the last decade. It can be used as a single dose and it is a reasonable tool do decrease cardioplegic interventions. Recent meta-analysis based on 9 retrospective studies has shown that "clinical outcomes of Del Nido cardioplegia are noninferior to the outcomes of conventional cardioplegia in adult cardiac surgery".
To assess the potencial benefits of Del Nido cardioplegia we performed this clinical trial to evaluate superiority of Del Nido cardioplegia compared to cold blood cardioplegia in terms of myocardial protection and clinical-related outcomes. 474 participants will be randomized either into Del Nido cardioplegia protocol or into the cold blood cardioplegia protocol. Perioperative outcomes will be presented.
Read the detailed description
This clinical trial is performed at Puerta de Hierro Hospital in Spain. The protocol has been approved by institutional ethical committee and Spanish Agency of medicines and medical devices (AEMPS).
The aim of the study is to evaluate superiority of Del Nido cardioplegia solution compared to cold blood cardioplegia solution in terms of myocardial protection and clinical-related outcomes.
According to results in recent meta-analysis, the author estimated a total sample size of 474 participants to give 80 % of power at the 5% significant level.
Participants aged 18 years or older undergoing elective cardiac surgery are randomized 1:1 to receive Del Nido cardioplegia solution (study group) and cold blood cardioplegia solution (control group).
Primary outcome will be assessed by biochemical variables of myocardial injury (troponin T level at inmediate post-op, 3-12 hours, 12-24 hours, 24-48 hours post-op); and clinical variables: "Presence of acute myocardial infarction within 72 hours after surgery", "Prolonged low cardiac output", "Prolonged postoperative vasoplegia" within 48 hours after surgery and/or "Ventricular tachyarrythmias" within 24 hours after surgery.
Secondary outcomes include intraoperative variables of myocardial protection (incidence of ventricular fibrillation, inotropic and vasopressor support at the end of surgical intervention, cardiopulmonary bypass time, aortic cross-clamp time) and postoperative clinical outcomes variables (mechanical ventilation time, incidence of delirium, stroke, acute renal failure, atrial fibrillation, length of stay in intensive care unit, length of stay in hospital and In-hospital mortality).
- Being tested
- DEL NIDO CARDIOPLEGIA, COLD BLOOD BASED CARDIOPLEGIA
- Keywords
- Del Nido Cardioplegia, Cardioplegia, Adult Cardiac Surgery, Myocardial protection, Heart surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DEL NIDO CARDIOPLEGIADrug
Del Nido components: Plasmalyte 148 (1000 ml), NaHCO3 8.4% 1M (13 ml), MgSO4 0,5 M (16,5 ml), Mannitol 20% (16,3 ml), KCl 2 M (13 ml), Lidocaine 2% (6,5 ml).
Electrolytic composition (l000 ml): Na+ 153 mEq, K+ 31 mEq, Cl - 124 mEq, Mg2+ 19,5 mEq, NaHCO3 13 mEq, Acetate 27 mEq, Sulfate 16,5 mEq, Gluconate 23 mEq.
COLD BLOOD BASED CARDIOPLEGIADrug
Also called CARDIBRAUN
Cardibraun components: Electrolytic composition (1000 ml): Na+ 185,8 mmol, K+ 24,1 mmol, Cl- 192,8 mmol, Acetate 23 mmol, Fosfate 0,97 mmol, Citrate 6,32 mmol.
| Study group | Role | What they receive |
|---|---|---|
| Del Nido Cardioplegia solution | Experimental | 1 liter of Del Nido cardioplegia after aortic cross-clamp will be given. Additional dose will be applied if aortic cross-clamp exceeds 90 minutes or whenever cardiac activity is observed. Receives: Drug: DEL NIDO CARDIOPLEGIA |
| Cold blood Cardioplegia solution | Active comparator | Administering of cardioplegia using current standard of care blood-based cardioplegia protocol. An induction dose of whole blood cardioplegia will be given at a temperature of 4-8 degrees, with subsequent doses of cardioplegia every 20 minutes or whenever cardiac activity is observed. Receives: Drug: COLD BLOOD BASED CARDIOPLEGIA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood troponin levels.
Biochemical variables of myocardial injury: Blood troponin levels measured at admission in intensive care unit, 12, 24, 48 hours post-op.
Measured: Up to 48 hours
Acute cardiovascular event.
Composite outcome of clinical events "Prolonged low cardiac output", "Prolonged postoperative vasoplegia", "Ventricular tachyarrythmias" and/or "Acute myocardial infarction".
- Prolonged low cardiac output. Inotropic pharmacologic support more than 48 hours in intensive care unit and/or mechanical circulatory support.
- Prolonged postoperative vasoplegia. Vasopressor support more than 48 hours in intensive care unit.
- Ventricular tachyarrythmias. Ventricular fibrillation and hemodynamically unstable ventricular tachycardia within 24 hours after surgery.
- Acute myocardial infarction within 72 hours after surgery.
Measured: Up to 72 hours
Secondary outcomes (21)
Ventricular fibrillation after aortic cross-clamp removal.
Incidence of ventricular fibrillation after aortic cross-clamp removal (Y/N).
Measured: Intraoperative.
Defibrillation requirement.
Defibrillation requirement after aortic cross-clamp removal (Y/N).
Measured: Intraoperative.
Cardioplegia delivery.
Cardioplegia delivery (antegrade, retrograde, both).
Measured: Intraoperative.
Cardiopulmonary bypass time (CBP).
Duration of cardiopulmonary bypass (CBP) (min).
Measured: Intraoperative.
Aortic cross-clamp time
Duration of aortic cross-clamp time (min).
Measured: Intraoperative.
Return to cardiopulmonary bypass.
Failure to separate from cardiopulmonary bypass (Y/N).
Measured: Intraoperative
Intraoperative packed red blood cells transfusion.
Intraoperative packed red blood cells transfusion (U).
Measured: Intraoperative
Intraoperative maximal blood glucose concentration.
Intraoperative maximal blood glucose concentration (mg/dl).
Measured: Intraoperative
Postoperative atrial fibrillation.
New-onset atrial fibrillation or hemodynamically unstable atrial fibrillation that requires treatment (Y/N).
Measured: Up to 2 weeks.
Reoperation.
Reoperation within 24 hours after surgery (Y/N).
Measured: Up to 24 hours.
Inotropic or vasopressor support in intensive care unit.
Inotropic or vasopressor support in intensive care unit (Y/N).
Measured: At admission in intensive care unit, 24, 48 hours.
Duration of inotropic support after cardiopulmonary bypass.
Duration of inotropic support after cardiopulmonary bypass (hours).
Measured: Up to 2 weeks.
Time to extubation.
Mechanical ventilation time (min).
Measured: Up to 2 weeks.
Acute renal failure.
Incidence of renal failure (Requirement for postoperative renal replacement therapy) (Y/N).
Measured: Up to 2 weeks.
Ischemic stroke.
Incidence of ischemic stroke (Y/N).
Measured: Up to 2 weeks.
Delirium.
Incidence of delirium (Y/N).
Measured: Up to 2 weeks.
Postoperative packed red blood cells transfusion.
Postoperative packed red blood cells transfusion (U)
Measured: Up to 1 week.
Length of stay in intensive care unit
Length of stay in intensive care unit (days).
Measured: through study completion, an average 1 month.
Length of stay in hospital
Length of stay in hospital (days).
Measured: through study completion, an average 6 months.
Postoperative ventricular ejection fraction change.
Postoperative ventricular ejection fraction (LVEF) change (Y/N).
Measured: through study completion, an average 6 months.
Mortality.
Mortality (Y/N).
Measured: through study completion, an average 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2019
- Study start15 Jun 2018
- Primary completion15 Dec 2019
- Study completion28 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Heart; Surgery, Heart, Functional Disturbance as ResultStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 474 participants (actual)
Sponsor and investigators
- Lead sponsor
- JESSICA GARCIA SUAREZ
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, JESSICA GARCIA SUAREZ, Puerta de Hierro University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04094168
- Sponsor's protocol ID
- EUDRA CT 2017-005144-14
- Status last verified
- Jul 2025
- First submitted
- 13 Sep 2019
- Last updated
- 22 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication.
Publications
Buckberg GD, Athanasuleas CL. Cardioplegia: solutions or strategies? Eur J Cardiothorac Surg. 2016 Nov;50(5):787-791. doi: 10.1093/ejcts/ezw228. Epub 2016 Jul 1. No abstract available.
PubMed 27369117Ad N, Holmes SD, Massimiano PS, Rongione AJ, Fornaresio LM, Fitzgerald D. The use of del Nido cardioplegia in adult cardiac surgery: A prospective randomized trial. J Thorac Cardiovasc Surg. 2018 Mar;155(3):1011-1018. doi: 10.1016/j.jtcvs.2017.09.146. Epub 2017 Nov 13.
PubMed 29246552Li Y, Lin H, Zhao Y, Li Z, Liu D, Wu X, Ji B, Gao B. Del Nido Cardioplegia for Myocardial Protection in Adult Cardiac Surgery: A Systematic Review and Meta-Analysis. ASAIO J. 2018 May/Jun;64(3):360-367. doi: 10.1097/MAT.0000000000000652.
PubMed 28863040Lazar HL. del Nido cardioplegia: Passing fad or here to stay? J Thorac Cardiovasc Surg. 2018 Mar;155(3):1009-1010. doi: 10.1016/j.jtcvs.2017.09.126. Epub 2017 Oct 10. No abstract available.
PubMed 29110949Tam DY, Fremes SE. Del Nido cardioplegia: A one stop shot for adult cardiac surgery? J Thorac Cardiovasc Surg. 2018 Mar;155(3):1019-1020. doi: 10.1016/j.jtcvs.2017.10.066. Epub 2017 Oct 31. No abstract available.
PubMed 29198802Garcia-Suarez J, Garcia-Fernandez J, Martinez Lopez D, Reques L, Sanz S, Carballo D, Martin CE, Ospina VM, Villar S, Martin A, Casado M, Villafranca A, Gonzalez AI, Serrano S, Forteza A. Clinical impact of del Nido cardioplegia in adult cardiac surgery: A prospective randomized trial. J Thorac Cardiovasc Surg. 2023 Nov;166(5):1458-1467. doi: 10.1016/j.jtcvs.2022.01.044. Epub 2022 Feb 8.
PubMed 35279289Garcia-Suarez J, Garcia Fernandez J, Sanz S, Martinez Lopez D, Reques L, Forteza Gil A. Del Nido Cardioplegia Versus Cold Blood Cardioplegia in Adult Cardiac Surgery: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2020 Jul 14;9(7):e17826. doi: 10.2196/17826.
PubMed 32673265
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes of Del Nido Cardioplegia in Adult Cardiac Surgery: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04094168
- Acronym / sponsor ID
- EUDRA CT 2017-005144-14
- Keywords
- Del Nido Cardioplegia, Cardioplegia, Adult Cardiac Surgery, Myocardial protection, Heart surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 474 participants (actual)
- Lead sponsor
- JESSICA GARCIA SUAREZUniversity, hospital or other
- Study start
- 15 Jun 2018 (actual)
- Primary completion
- 15 Dec 2019 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 18 Sep 2019 (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.
Cardioplegia solutions have been used for myocardial protection in cardiac surgery for decades. Different cardioplegic strategies have been evaluated.
Del Nido cardioplegia was initially used in pediatric patients and has been expanding into adult cardiac centers over the last decade. It can be used as a single dose and it is a reasonable tool do decrease cardioplegic interventions. Recent meta-analysis based on 9 retrospective studies has shown that "clinical outcomes of Del Nido cardioplegia are noninferior to the outcomes of conventional cardioplegia in adult cardiac surgery".
To assess the potencial benefits of Del Nido cardioplegia we performed this clinical trial to evaluate superiority of Del Nido cardioplegia compared to cold blood cardioplegia in terms of myocardial protection and clinical-related outcomes. 474 participants will be randomized either into Del Nido cardioplegia protocol or into the cold blood cardioplegia protocol. Perioperative outcomes will be presented.
Detailed description
This clinical trial is performed at Puerta de Hierro Hospital in Spain. The protocol has been approved by institutional ethical committee and Spanish Agency of medicines and medical devices (AEMPS).
The aim of the study is to evaluate superiority of Del Nido cardioplegia solution compared to cold blood cardioplegia solution in terms of myocardial protection and clinical-related outcomes.
According to results in recent meta-analysis, the author estimated a total sample size of 474 participants to give 80 % of power at the 5% significant level.
Participants aged 18 years or older undergoing elective cardiac surgery are randomized 1:1 to receive Del Nido cardioplegia solution (study group) and cold blood cardioplegia solution (control group).
Primary outcome will be assessed by biochemical variables of myocardial injury (troponin T level at inmediate post-op, 3-12 hours, 12-24 hours, 24-48 hours post-op); and clinical variables: "Presence of acute myocardial infarction within 72 hours after surgery", "Prolonged low cardiac output", "Prolonged postoperative vasoplegia" within 48 hours after surgery and/or "Ventricular tachyarrythmias" within 24 hours after surgery.
Secondary outcomes include intraoperative variables of myocardial protection (incidence of ventricular fibrillation, inotropic and vasopressor support at the end of surgical intervention, cardiopulmonary bypass time, aortic cross-clamp time) and postoperative clinical outcomes variables (mechanical ventilation time, incidence of delirium, stroke, acute renal failure, atrial fibrillation, length of stay in intensive care unit, length of stay in hospital and In-hospital mortality).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Del Nido Cardioplegia solution | Experimental | Drug: DEL NIDO CARDIOPLEGIA1 liter of Del Nido cardioplegia after aortic cross-clamp will be given. Additional dose will be applied if aortic cross-clamp exceeds 90 minutes or whenever cardiac activity is observed. |
| Cold blood Cardioplegia solution | Active comparator | Drug: COLD BLOOD BASED CARDIOPLEGIAAdministering of cardioplegia using current standard of care blood-based cardioplegia protocol. An induction dose of whole blood cardioplegia will be given at a temperature of 4-8 degrees, with subsequent doses of cardioplegia every 20 minutes or whenever cardiac activity is observed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients age 18 years or older undergoing adult cardiac surgery.
- Elective surgical procedures requiring cardiopulmonary bypass and myocardial arrest.
Key exclusion criteria (5 listed)
- Emergency surgery.
- Patients on preoperative inotropic support and/or mechanical circulatory support.
- Patient who refuse to participate in the study.
- Lidocaine allergy.
- Port access mitral valve surgery.
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 |
|---|---|---|
| DEL NIDO CARDIOPLEGIADel Nido components: Plasmalyte 148 (1000 ml), NaHCO3 8.4% 1M (13 ml), MgSO4 0,5 M (16,5 ml), Mannitol 20% (16,3 ml), KCl 2 M (13 ml), Lidocaine 2% (6,5 ml). Electrolytic composition (l000 ml): Na+ 153 mEq, K+ 31 mEq, Cl - 124 mEq, Mg2+ 19,5 mEq, NaHCO3 13 mEq, Acetate 27 mEq, Sulfate 16,5 mEq, Gluconate 23 mEq. | Drug | Del Nido Cardioplegia solution |
| COLD BLOOD BASED CARDIOPLEGIAAlso: CARDIBRAUNCardibraun components: Electrolytic composition (1000 ml): Na+ 185,8 mmol, K+ 24,1 mmol, Cl- 192,8 mmol, Acetate 23 mmol, Fosfate 0,97 mmol, Citrate 6,32 mmol. | Drug | Cold blood Cardioplegia solution |
Primary outcome
Blood troponin levels.
Time frame: Up to 48 hours
Biochemical variables of myocardial injury: Blood troponin levels measured at admission in intensive care unit, 12, 24, 48 hours post-op.
Acute cardiovascular event.
Time frame: Up to 72 hours
Composite outcome of clinical events "Prolonged low cardiac output", "Prolonged postoperative vasoplegia", "Ventricular tachyarrythmias" and/or "Acute myocardial infarction". * Prolonged low cardiac output. Inotropic pharmacologic support more than 48 hours in intensive care unit and/or mechanical circulatory support. * Prolonged postoperative vasoplegia. Vasopressor support more than 48 hours in intensive care unit. * Ventricular tachyarrythmias. Ventricular fibrillation and hemodynamically unstable ventricular tachycardia within 24 hours after surgery. * Acute myocardial infarction within 72 hours after surgery.
21 secondary outcomes
Ventricular fibrillation after aortic cross-clamp removal.
Time frame: Intraoperative.
Defibrillation requirement.
Time frame: Intraoperative.
Cardioplegia delivery.
Time frame: Intraoperative.
Cardiopulmonary bypass time (CBP).
Time frame: Intraoperative.
Aortic cross-clamp time
Time frame: Intraoperative.
Return to cardiopulmonary bypass.
Time frame: Intraoperative
Intraoperative packed red blood cells transfusion.
Time frame: Intraoperative
Intraoperative maximal blood glucose concentration.
Time frame: Intraoperative
Postoperative atrial fibrillation.
Time frame: Up to 2 weeks.
Reoperation.
Time frame: Up to 24 hours.
Inotropic or vasopressor support in intensive care unit.
Time frame: At admission in intensive care unit, 24, 48 hours.
Duration of inotropic support after cardiopulmonary bypass.
Time frame: Up to 2 weeks.
Time to extubation.
Time frame: Up to 2 weeks.
Acute renal failure.
Time frame: Up to 2 weeks.
Ischemic stroke.
Time frame: Up to 2 weeks.
Delirium.
Time frame: Up to 2 weeks.
Postoperative packed red blood cells transfusion.
Time frame: Up to 1 week.
Length of stay in intensive care unit
Time frame: through study completion, an average 1 month.
Length of stay in hospital
Time frame: through study completion, an average 6 months.
Postoperative ventricular ejection fraction change.
Time frame: through study completion, an average 6 months.
Mortality.
Time frame: through study completion, an average 6 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2025.
- Background: PubMed 27369117Buckberg GD, Athanasuleas CL. Cardioplegia: solutions or strategies? Eur J Cardiothorac Surg. 2016 Nov;50(5):787-791. doi: 10.1093/ejcts/ezw228. Epub 2016 Jul 1. No abstract available.
- Background: PubMed 29246552Ad N, Holmes SD, Massimiano PS, Rongione AJ, Fornaresio LM, Fitzgerald D. The use of del Nido cardioplegia in adult cardiac surgery: A prospective randomized trial. J Thorac Cardiovasc Surg. 2018 Mar;155(3):1011-1018. doi: 10.1016/j.jtcvs.2017.09.146. Epub 2017 Nov 13.
- Background: PubMed 28863040Li Y, Lin H, Zhao Y, Li Z, Liu D, Wu X, Ji B, Gao B. Del Nido Cardioplegia for Myocardial Protection in Adult Cardiac Surgery: A Systematic Review and Meta-Analysis. ASAIO J. 2018 May/Jun;64(3):360-367. doi: 10.1097/MAT.0000000000000652.
- Background: PubMed 29110949Lazar HL. del Nido cardioplegia: Passing fad or here to stay? J Thorac Cardiovasc Surg. 2018 Mar;155(3):1009-1010. doi: 10.1016/j.jtcvs.2017.09.126. Epub 2017 Oct 10. No abstract available.
- Background: PubMed 29198802Tam DY, Fremes SE. Del Nido cardioplegia: A one stop shot for adult cardiac surgery? J Thorac Cardiovasc Surg. 2018 Mar;155(3):1019-1020. doi: 10.1016/j.jtcvs.2017.10.066. Epub 2017 Oct 31. No abstract available.
- Derived from this study: PubMed 35279289Garcia-Suarez J, Garcia-Fernandez J, Martinez Lopez D, Reques L, Sanz S, Carballo D, Martin CE, Ospina VM, Villar S, Martin A, Casado M, Villafranca A, Gonzalez AI, Serrano S, Forteza A. Clinical impact of del Nido cardioplegia in adult cardiac surgery: A prospective randomized trial. J Thorac Cardiovasc Surg. 2023 Nov;166(5):1458-1467. doi: 10.1016/j.jtcvs.2022.01.044. Epub 2022 Feb 8.
- Derived from this study: PubMed 32673265Garcia-Suarez J, Garcia Fernandez J, Sanz S, Martinez Lopez D, Reques L, Forteza Gil A. Del Nido Cardioplegia Versus Cold Blood Cardioplegia in Adult Cardiac Surgery: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2020 Jul 14;9(7):e17826. doi: 10.2196/17826.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 DEL NIDO CARDIOPLEGIA and COLD BLOOD BASED CARDIOPLEGIA in people with Heart; Surgery, Heart, Functional Disturbance as Result, run by JESSICA GARCIA SUAREZ at 1 site in Spain.
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 2 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: finished, as of the sponsor's last update on 22 Jul 2025. 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 Spain. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood troponin levels. (time frame: Up to 48 hours). The study lists 2 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 NCT04094168, which also lists 7 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 22 Jul 2025.