Aortic Valve DiseaseNCT03818126
The Del Nido Versus Cold Blood Cardioplegia in Aortic Valve Replacement
A study testing del Nido cardioplegia and cold blood cardioplegia in people with Aortic Valve Disease and Ischemia-reperfusion Injury, run by Pawel Buszman at 1 site in Poland.
Trial summary
A group of 150 patients undergoing aortic valve replacement procedure will be randomized either into del Nido cardioprotection protocol (75 participants) or into the cold blood cardioplegia protocol (75 participants). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Disease, Ischemia-reperfusion Injury
- What is being tested?
- del Nido cardioplegia and cold blood cardioplegia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jul 2016to 31 Jul 2018
- Phase
- Interventional
- 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
- qualification for isolated aortic valve replacement
- age>18 years
- given consent for the study
Who cannot join
- reoperation
- allergy to lidocaine
- coronary artery disease requiring surgical or percutaneous intervention
- pregnancy
- ejection fraction<30%
- massive aortic calcification ("porcelain aorta")
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Del Nido Cardioplegia Versus the Cold Blood Cardioplegia in Adult Patients Undergoing Aortic Valve Replacement
A group of 150 patients undergoing aortic valve replacement procedure will be randomized either into del Nido cardioprotection protocol (75 participants) or into the cold blood cardioplegia protocol (75 participants).
The intraoperative and perioperative outcomes of using each solution will be presented and compared (see the endpoints).
Read the detailed description
The del Nido cardioplegia was developed by Pedro del Nido and his team at the University of Pittsburgh in 1990s. It was primarily designed for children and it has been used in pediatric cardiac surgery in Boston's Children Hospital since 1994.
There are few studies regarding the del Nido cardioplegia. A prospective, randomized trial was designed to determine the efficiency of the del Nido cardioplegia when compared to multidose cold blood cardioplegia in cardiac procedures with short and moderate cross-clamp times.
For the analysis of two cardioprotection protocols, it is essential to compare groups equal in terms of the surgery and perioperative care, with the same surgical risk and cross-clamp time. The research required elimination of all the unnecessary variables.
The patients undergoing aortic valve replacement procedure were selected as a study population. A group of 150 patients will be randomized either into del Nido cardioprotection protocol (75 participants) or into the cold blood cardioplegia protocol (75 participants).
The intraoperative and perioperative outcomes of using each solution will be presented and compared (see the endpoints).
- Conditions
- Aortic Valve Disease, Ischemia-reperfusion Injury
- Being tested
- del Nido cardioplegia, cold blood cardioplegia
- Keywords
- del Nido, cardioplegia, aortic valve
- Medical subject headings
- Aortic Valve Disease, Reperfusion Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
del Nido cardioplegiaDrug
The del Nido components are: Plasma-Lyte A (1000ml), Mannitol 20% (16.3ml), MgSO4 50% (4ml) , NaHCO3 8.4% (13ml) , KCl 2mEq/mL (13ml), Lidocaine 1% (13ml). This solution is mixed with autologous patient blood from the cardiopulmonary circuit in a 4:1 ratio (crystalloid:blood).
The dosage is 20ml/kg. The target administration pressure is 100-200mmHg and the target administration flow is 200-300ml/min. The solution temperature is 4 degrees Celsius. Additional dose of the cardioplegia is given only if the cross-clamp time exceeds 90 minutes. Due to high volume given in a single delivery, 40 milligrams of furosemide are injected into cardiopulmonary circuit.
cold blood cardioplegiaDrug
The cold blood cardioplegia components are: Plasma-Lyte A (435ml), Mannitol 15% (20ml), NaHCO3 8.4% (20ml), KCl 2mEq/mL (25ml). The solution is mixed with autologous patient blood from the cardiopulmonary circuit in a 1:4 ratio (crystalloid:blood).
The initial dose is 15ml/kg and a dose of 5ml/kg is added every 20-30 minutes or whenever cardiac activity is observed. The target administration pressure is 100-200mmHg and the target administration flow is 200-300ml/min. The solution temperature is 4 degrees Celsius.
| Study group | Role | What they receive |
|---|---|---|
| del Nido cardioplegia | Experimental | Not described Receives: Drug: del Nido cardioplegia |
| cold blood cardioplegia | Active comparator | Not described Receives: Drug: cold blood cardioplegia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electrical cardiac activity during cross-clamp
Electrical activity observed during the cardiac arrest (cross-clamp)
Measured: intraoperative
Ventricular fibrillation during reperfusion
Ventricular fibrillation as first observed rhythm after removing the aortic cross-clamp
Measured: intraoperative
hs-TnT (High sensitivity troponin T) - 24 hours
High sensitivity troponin T measured 24 hours postoperatively
Measured: 24 hours postoperatively
hs-TnT (High sensitivity troponin T) - 48 hours
High sensitivity troponin T measured 48 hours postoperatively
Measured: 48 hours postoperatively
CK-MB (Creatine kinase- MB isoenzyme) - 24 hours
Creatine kinase (MB isoenzyme) measured 24 hours postoperatively
Measured: 24 hours postoperatively
CK-MB (Creatine kinase- MB isoenzyme) - 48 hours
Creatine kinase (MB isoenzyme) measured 48 hours postoperatively
Measured: 48 hours postoperatively
Secondary outcomes (15)
Ventricular fibrillation during the cardioplegia administration
Measured: intraoperative
Time from the beginning of cardioplegia administration to cardiac arrest
Measured: intraoperative
Procedural use of the pacemaker
Measured: intraoperative
Intraoperative myocardial infarction
Measured: intraoperative
Fall of ejection fraction (EF)
5% fall in the EF
Measured: 48 hours
Inotrope administration
Measured: intraoperative, 48 hours
Use of the intraaortic balloon pump
Measured: intraoperative, 48 hours
Perioperative atrial fibrillation
Measured: up to 2 weeks
Perioperative arrhythmia (other than AF)
Measured: up to 2 weeks
Postoperative packed red blood cells transfusion
Measured: up to 2 weeks
Perioperative creatinine values
Measured: up to 2 weeks
Kidney injury
The creatinine elevation >25% or >0.5mg/dl
Measured: up to 2 weeks
CVVHDF
Use of continous veno-venous hemodiafiltration
Measured: up to 2 weeks
Cardiac death
death from cardiac reasons (e.g. myocardial infarction, low ejection fraction, arrhythmia).
Measured: 30 days postoperative
Overall mortality
Measured: 30 days postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2019
- Study start1 Jul 2016
- Primary completion30 Jun 2018
- Study completion31 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve DiseaseStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pawel Buszman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Pawel Buszman, American Heart of Poland
- Investigators
- Marek Cisowski, MD,PhD, Principal investigator, 1st Department of Cardiac Surgery, American Heart of Poland, Bielsko-Biala, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03818126
- Sponsor's protocol ID
- DELNIDO01
- Status last verified
- Jan 2019
- First submitted
- 20 Jan 2019
- Last updated
- 28 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Del Nido Cardioplegia Versus the Cold Blood Cardioplegia in Adult Patients Undergoing Aortic Valve Replacement
- ClinicalTrials.gov ID
- NCT03818126
- Acronym / sponsor ID
- DELNIDO01
- Conditions
- Aortic Valve Disease, Ischemia-reperfusion Injury
- Keywords
- del Nido, cardioplegia, aortic valve
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Pawel BuszmanUniversity, hospital or other
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 31 Jul 2018 (actual)
- First posted
- 28 Jan 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.
A group of 150 patients undergoing aortic valve replacement procedure will be randomized either into del Nido cardioprotection protocol (75 participants) or into the cold blood cardioplegia protocol (75 participants).
The intraoperative and perioperative outcomes of using each solution will be presented and compared (see the endpoints).
Detailed description
The del Nido cardioplegia was developed by Pedro del Nido and his team at the University of Pittsburgh in 1990s. It was primarily designed for children and it has been used in pediatric cardiac surgery in Boston's Children Hospital since 1994.
There are few studies regarding the del Nido cardioplegia. A prospective, randomized trial was designed to determine the efficiency of the del Nido cardioplegia when compared to multidose cold blood cardioplegia in cardiac procedures with short and moderate cross-clamp times.
For the analysis of two cardioprotection protocols, it is essential to compare groups equal in terms of the surgery and perioperative care, with the same surgical risk and cross-clamp time. The research required elimination of all the unnecessary variables.
The patients undergoing aortic valve replacement procedure were selected as a study population. A group of 150 patients will be randomized either into del Nido cardioprotection protocol (75 participants) or into the cold blood cardioplegia protocol (75 participants).
The intraoperative and perioperative outcomes of using each solution will be presented and compared (see the endpoints).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| del Nido cardioplegia | Experimental | Drug: del Nido cardioplegia |
| cold blood cardioplegia | Active comparator | Drug: cold blood cardioplegia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- qualification for isolated aortic valve replacement
- age>18 years
- given consent for the study
Key exclusion criteria (6 listed)
- reoperation
- allergy to lidocaine
- coronary artery disease requiring surgical or percutaneous intervention
- pregnancy
- ejection fraction<30%
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 cardioplegiaThe del Nido components are: Plasma-Lyte A (1000ml), Mannitol 20% (16.3ml), MgSO4 50% (4ml) , NaHCO3 8.4% (13ml) , KCl 2mEq/mL (13ml), Lidocaine 1% (13ml). This solution is mixed with autologous patient blood from the cardiopulmonary circuit in a 4:1 ratio (crystalloid:blood). The dosage is 20ml/kg. The target administration pressure is 100-200mmHg and the target administration flow is 200-300ml/min. The solution temperature is 4 degrees Celsius. Additional dose of the cardioplegia is given only if the cross-clamp time exceeds 90 minutes. Due to high volume given in a single delivery, 40 milligrams of furosemide are injected into cardiopulmonary circuit. | Drug | del Nido cardioplegia |
| cold blood cardioplegiaThe cold blood cardioplegia components are: Plasma-Lyte A (435ml), Mannitol 15% (20ml), NaHCO3 8.4% (20ml), KCl 2mEq/mL (25ml). The solution is mixed with autologous patient blood from the cardiopulmonary circuit in a 1:4 ratio (crystalloid:blood). The initial dose is 15ml/kg and a dose of 5ml/kg is added every 20-30 minutes or whenever cardiac activity is observed. The target administration pressure is 100-200mmHg and the target administration flow is 200-300ml/min. The solution temperature is 4 degrees Celsius. | Drug | cold blood cardioplegia |
Primary outcome
Electrical cardiac activity during cross-clamp
Time frame: intraoperative
Electrical activity observed during the cardiac arrest (cross-clamp)
Ventricular fibrillation during reperfusion
Time frame: intraoperative
Ventricular fibrillation as first observed rhythm after removing the aortic cross-clamp
hs-TnT (High sensitivity troponin T) - 24 hours
Time frame: 24 hours postoperatively
High sensitivity troponin T measured 24 hours postoperatively
hs-TnT (High sensitivity troponin T) - 48 hours
Time frame: 48 hours postoperatively
High sensitivity troponin T measured 48 hours postoperatively
CK-MB (Creatine kinase- MB isoenzyme) - 24 hours
Time frame: 24 hours postoperatively
Creatine kinase (MB isoenzyme) measured 24 hours postoperatively
CK-MB (Creatine kinase- MB isoenzyme) - 48 hours
Time frame: 48 hours postoperatively
Creatine kinase (MB isoenzyme) measured 48 hours postoperatively
15 secondary outcomes
Ventricular fibrillation during the cardioplegia administration
Time frame: intraoperative
Time from the beginning of cardioplegia administration to cardiac arrest
Time frame: intraoperative
Procedural use of the pacemaker
Time frame: intraoperative
Intraoperative myocardial infarction
Time frame: intraoperative
Fall of ejection fraction (EF)
Time frame: 48 hours
Inotrope administration
Time frame: intraoperative, 48 hours
Use of the intraaortic balloon pump
Time frame: intraoperative, 48 hours
Perioperative atrial fibrillation
Time frame: up to 2 weeks
Perioperative arrhythmia (other than AF)
Time frame: up to 2 weeks
Postoperative packed red blood cells transfusion
Time frame: up to 2 weeks
Perioperative creatinine values
Time frame: up to 2 weeks
Kidney injury
Time frame: up to 2 weeks
CVVHDF
Time frame: up to 2 weeks
Cardiac death
Time frame: 30 days postoperative
Overall mortality
Time frame: 30 days postoperative
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 28 Jan 2019.
- Individual participant dataSharing planned: No
Related trials for Aortic Valve Disease
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
Active, not recruitingObservational study
Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
Iliac Disease, Aortic Valve Stenosis
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic
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.
Marek Cisowski, MD,PhD principal investigator
1st Department of Cardiac Surgery, American Heart of Poland, Bielsko-Biala, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing del Nido cardioplegia and cold blood cardioplegia in people with Aortic Valve Disease and Ischemia-reperfusion Injury, run by Pawel Buszman at 1 site in Poland.
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 3 inclusion and 6 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 28 Jan 2019. 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 Poland. 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.
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?
Electrical cardiac activity during cross-clamp (time frame: intraoperative). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jan 2019.