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

Completed · Phase 2

Conditions studied: Coronary Artery Disease, Myocardial Ischemia, Coronary Disease, Heart Diseases, Valvular Heart Disease

In brief

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.

Key facts

Study ID

NCT01681095

Run by

Marc Sakwa, MD

People needed

110

Starts

2012-08-01

Expected to finish

2016-04-01

Last updated by the study team

2019-08-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients undergoing scheduled cardiac surgery requiring cardioplegic arrest with expected cross clamp time>45 minutes
• Patients age 18 and older

You may not qualify if…

• 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.

Where it is running

• William Beaumont Hospital — Royal Oak, Michigan, United States

Full record on ClinicalTrials.gov

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