Del Nido Versus HTK Cardioplegia in Adult Aortic Valve Replacement

NCT06235424 | Unknown Phase 4

• 1 other identifier: NKBBN/203/2018
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to compare del Nido and Bretschneider-HTK (HTK) cardioplegia solutions in patients undergoing elective aortic valve replacement. The main question it aims to answer is: • Does the del Nido cardioplegia provide better cardioprotection and clinical outcomes than HTK cardioplegia? Participants will receive one of the investigated cardioplegia solutions according to the randomization. Researchers will compare both groups in terms of cardioprotection (described as levels of CK-MB and hsTnI), in-hospital clinical outcomes, biochemical changes in coronary sinus blood and one-year follow-up.

Conditions

Aortic Valve Disease; Valve Disease, Heart; Cardiac Ischemia

Keywords

del Nido cardioplegia; Bretschneider HTK cardioplegia; cardioprotection; cardiac surgery; aortic valve replacement

Outcome Measures

Primary Outcomes (2)

• postoperative CK-MB

  concentration of serum creatine kinase-myocardial band (CK-MB)

  measured in the 6th, 24th, and 48th hour postoperatively

• postoperative hsTnI

  concentration of serum high sensitive cardiac troponin I (hsTnI)

  measured in the 6th, 24th, and 48th hour postoperatively

Secondary Outcomes (46)

• CPB time

  intraoperative

• XC time

  intraoperative

• Reperfusion time

  intraoperative

• Cardioplegia volume

  intraoperative

• Cardioplegia doses

  intraoperative

Study Arms (2)

del Nido cardioplegia group

ACTIVE COMPARATOR

A group of patients that received high potassium cardioplegic solution with the addition of lidocaine, mixed with the patient's blood in 4:1 ratio

Drug: Del Nido Cardioplegia Solution

Bretschneider-HTK cardioplegia group

ACTIVE COMPARATOR

A group of patients that received low sodium cardioplegic solution with the addition of histidine, tryptophan and alpha-ketoglutarate

Drug: HTK solution

Interventions

Del Nido Cardioplegia Solution DRUG

The route of cardioplegia delivery differed according to surgeons' preferences. The total dosage of cardioplegia depends on the type of cardioplegia. The standard dose of del Nido cardioplegia in our institution is 1000 ml as an initial dose and is delivered with a system pressure of 90-150 mmHg. The solution is prepared by our hospital's pharmacy. At 60. minute of cross-clamp (XC) if XC time was expected to exceed 90 minutes another dose of solution would be delivered. The volume of an additional dose was 500 ml. The temperature of the delivered del Nido cardioplegia was 4\*C.

Also known as: del Nido, DNC

del Nido cardioplegia group

HTK solution DRUG

The route of cardioplegia delivery differed according to surgeons' preferences. The dose of the HTK cardioplegia is calculated with an application of 20 mL/kg rule. It is delivered with a system pressure of 90-150 mmHg. If the XC time exceeds 120 minutes additional dose is given (10 mL/kg rule). The temperature of the delivered crystalloid cardioplegia is 4\*C

Also known as: HTK, Bretschneider-HTK

Bretschneider-HTK cardioplegia group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients aged 18 and over,
• qualified for elective isolated aortic valve replacement (AVR)

You may not qualify if:

• patients with significant coronary artery disease,
• urgent cases,
• cases with additional cardiac procedures.

Sponsors & Collaborators

• Medical University of Gdansk: lead

Study Sites (1)

Medical University of Gdańsk

Gdansk, Pomeranian Voivodeship, 80-282, Poland

Location

MeSH Terms

Conditions

Aortic Valve Disease; Heart Valve Diseases; Coronary Artery Disease

Interventions

Del Nido cardioplegia solution; Bretschneider cardioplegic solution

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Coronary Disease; Myocardial Ischemia; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Barbara Brzeska, MD

  Medical Univeristy of Gdansk

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 5, 2023
• First Posted: January 31, 2024
• Study Start: October 1, 2018
• Primary Completion: April 24, 2023
• Study Completion: September 24, 2024
• Last Updated: January 31, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR, ANALYTIC CODE
• Time Frame: was not yet determined
• Access Criteria: The data underlying this article will be shared on reasonable request

Locations

PL (1)