Overview

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

Status:
Completed
Trial end date:
2016-04-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Marc Sakwa, MD
Collaborator:
Essential Pharmaceuticals, LLC
Treatments:
Cardioplegic Solutions
Mannitol
Pharmaceutical Solutions
Procaine
Tryptophan
Criteria
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.