Clinical trial to compare the efficacy and safety of Buckberg versus Del Nido cardioplegia in isolated myocardial revascularization surgery

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Fundacio Institut De Recerca De L Hospital De La Santa Creu I Sant Pau

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Analytical,Diagnostic,Therapeutic Techniques and Equipment [E]-Surgical Procedures, Operative [E04], Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

20 Mar 2024 → ongoing

Decision date (initial)

2024-02-15

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

The main objective of the study is to study the efficacy and safety in terms of myocardial protection in patients undergoing isolated myocardial revascularization surgery with extracorporeal circulation of two cardioplegic solutions: Del Nido cardioplegia versus Buckberg cardioplegia. For this purpose, levels of myocardial injury markers (CK and Troponin T) and in-hospital mortality will be compared between both strategies.

Secondary objectives 3

1. Other markers of myocardial injury will be compared: perioperative myocardial infarction, LVEF by transthoracic echocardiography, cardiac resonance, need for postoperative inotropes, need for ventricular assist devices, spontaneous recovery of post-unclamping cardiac rhythm or need for defibrillation.
2. Hemodilution parameters (minimum intraoperative and postoperative hemoglobin, as well as the need for transfusion), intra and postoperative glucose and insulin needs, surgery times (total time, CPB time, aortic clamping time) and other intraoperative and postoperative analytical parameters (maximum lactate) will be compared..
3. Data will be collected on adverse events in the postoperative period: episode of atrial fibrillation, renal failure and need for replacement therapy, stroke, reintervention due to bleeding, infection

Conditions and MedDRA coding

Cardiovascular pathology

Regulatory references

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Patients of legal age (>18 years) of both sexes.
2. Patients undergoing isolated myocardial revascularization surgery with extracorporeal circulation.
3. Patients providing the informed consent.

Exclusion criteria 4

1. Emergent surgery
2. Acute coronary syndrome with or without ST elevation in the last 48 hours.
3. Patient who rejects blood products
4. Patients with concomitant medical conditions that determine the need to use one or another cardioplegic solution; such as advanced chronic kidney disease, diabetes with poor glycemic control or significant preoperative anemia that requires hemodilution to be reduced as much as possible.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Markers of myocardial damage: Peak levels of CK in U/L and ultrasensitive Troponin T in ng/L in blood. Basal levels will be determined daily during the first 5 postoperative days. The peak of CK and Troponin T will be recorded for each of the study subjects (usually it occurs during postoperative days 2 and 4).
2. Operative mortality. Operative mortality will be considered mortality in the following 30 days after the surgical intervention, or mortality during admission for the intervention (in patients whose admission exceeds 30 postoperative days).

Secondary endpoints 19

1. Aortic clamping time (minutes)
2. Extracorporeal circulation time (minutes)
3. Spontaneous recovery of the rhythm after aortic unclamping: it will be recorded during the intraoperative period if there is spontaneous recovery of the cardiac rhythm after removing the aortic clamp.
4. Need for post-aortic unclamping defibrillation: it will be recorded if defibrillation is necessary to recover one's own heart rhythm.
5. Need for inotropes for weaning from CPB: it will be recorded if the administration of inotropes is necessary for weaning from CPB. If yes, the type and maximum dose of inotrope required will be recorded.
6. Maximum intraoperative blood glucose (in mmol/L).
7. Intraoperative insulin needs and during the 48 hours postoperatively.
8. Minimum intraoperative, postoperative and discharge hemoglobin (in g/L).
9. Maximum intraoperative lactate (in mmol/L),
10. Need for intraoperative and postoperative red blood cell transfusion.
11. Inotrope need and duration during intra- and postoperative.
12. Need for mechanical circulatory assistance: need for circulatory support using a counterpulsation balloon or ECMO.
13. Perioperative myocardial infarction according to the 5th universal definition.
14. Episodes of de novo atrial fibrillation.
15. Intubation hours.
16. Left ventricular function by echocardiography at discharge.
17. Cardiac resonance (subgroup of patients): one pre-surgery and another 7-10 days after surgery with cine sequences, mapping and late enhancement.
18. Days of admission to the ICU.
19. Total hospitalization days.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Fundacio Institut De Recerca De L Hospital De La Santa Creu I Sant Pau

Sponsor organisation

Fundacio Institut De Recerca De L Hospital De La Santa Creu I Sant Pau

Address

Calle De San Quintin 77-79

City

Barcelona

Postcode

08041

Country

Spain

Scientific contact point

Organisation

Fundacio Institut De Recerca De L Hospital De La Santa Creu I Sant Pau

Contact name

Manel Tauron Ferrer

Public contact point

Organisation

Fundacio Institut De Recerca De L Hospital De La Santa Creu I Sant Pau

Contact name

Manel Tauron Ferrer

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Application history

1 submissions — initial application plus substantial / non-substantial modifications