Custodiol-HTK (Histidine-tryptophan-ketoglutarate) Solution as a Cardioplegic Agent

Marc Sakwa, MD110 enrolled

Overview

The purpose of the study is to demonstrate that Custodiol-HTK is not inferior to cold cardioplegic solution in patients undergoing cardiovascular surgery requiring cardioplegic arrest.

The objective of this study is to demonstrate that Custodiol is not inferior to cold cardioplegic solution for myocardial protection by comparing standard cold blood cardioplegia to Custodiol solution with respect to myocardial injury as measured by Creatine phosphokinase MB isoenzyme (CK-MB),troponin-I at 7 hours post surgery and changes in ejection fraction by trans-thoracic echocardiogram (TTE)or trans-esophageal echocardiogram (TEE) at 24 hours post surgery.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

110

Conditions

Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases Valvular Heart Disease

Interventions

Custodiol HTKDRUG

After cross-clamping of the aorta approximately 1-2 L of Custodiol-HTK was infused into the ascending aorta over 6-8 minutes. Additional doses of 100-200 ml were administered as needed. The cardioplegic solution was delivered at a temperature of 4°C - 10°C.

Cold Blood CardioplegiaDRUG

After cross-clamping the aorta, at least 1000 mL of a 4:1 mixture of cold blood: cold crystalloid was administered at a pressure of 300 mmHg or less via a twin roller pump. Every 20 minutes an additional \> 200 mL was administered in an antegrade/retrograde fashion throughout the remainder of the case. The cardioplegic solution was delivered at a temperature of 4°C - 8°C.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients undergoing scheduled cardiac surgery requiring cardioplegic arrest with expected cross clamp time\>45 minutes * Patients age 18 and older Exclusion Criteria: * Pregnant women\* * Urgent or emergent cases * Repeat cardiovascular surgical procedures * Patients on dialysis * Any known allergies to components of either cardioplegia solution \*All women of child bearing potential must have a negative serum or urine pregnancy test.

Locations (1)

William Beaumont Hospital

Royal Oak, Michigan, United States

Outcomes

Primary Outcomes

Change in Creatine Phosphokinase-MB Isoenzyme (CK-MB)

Creatine phosphokinase MB isoenzyme (CK-MB) difference from baseline 7 hours post surgery

Time frame: Baseline and 7 hours post surgery

Change in Troponin I

Troponin I values, difference from baseline 7 hours post surgery

Time frame: Baseline and 7 hours post surgery

Changes in Left Ventricular (LV) Ejection Fraction (EF) by Transthoracic Echocardiogram (TTE)

LV ejection fraction by TTE, difference from baseline at 24 hours post surgery

Time frame: Baseline and 24 hours post surgery

Secondary Outcomes

Cardiac Dysrhythmias

Number of participants with new or worsening of cardiac dysrhythmias

Time frame: up to 36 hrs post surgery

All Cause Mortality

Number of participants with all-cause mortality AS reported in the Society of Thoracic Surgeons (STS) database after 30 days postoperative

Time frame: 30 days post procedure

Cardiovascular Mortality

Number of participants with cardiovascular-related mortality AS reported in the Society of Thoracic Surgeons (STS) database after 30 days postoperative

Time frame: 30 days post procedure

Time on Mechanically Assisted Ventilation

time in hours from intubation to extubation, with intervening transport to the cardiac critical care unit.

Time frame: up to 36 hours post procedure

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.