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

PHASE2CompletedINTERVENTIONAL
Enrollment

110

Participants

Timeline

Start Date

August 31, 2012

Primary Completion Date

August 31, 2014

Study Completion Date

April 30, 2016

Conditions
Coronary Artery DiseaseMyocardial IschemiaCoronary DiseaseHeart DiseasesValvular Heart Disease
Interventions
DRUG

Custodiol HTK

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.

DRUG

Cold Blood Cardioplegia

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.

Trial Locations (1)

48073

William Beaumont Hospital, Royal Oak

Sponsors
All Listed Sponsors
collaborator

Essential Pharmaceuticals, LLC

OTHER

lead

Marc Sakwa, MD

OTHER