Custodiol-HTK Solution as a Cardioplegic Agent



Status:Completed
Conditions:Angina, Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:5/5/2014
Start Date:August 2012
End Date:June 2014
Contact:Diane Tapp, RN, BSN
Email:dtapp@beaumont.edu
Phone:248-551-0194

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Trial Summary
Trial Overview
Inclusion Criteria

Custodiol-HTK Solution as a Cardioplegic Agent- A Prospective Non-Inferiority Randomized Clinical Trial

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.

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.
We found this trial at
1
site
William Beaumont Hospital-Royal Oak
3601 W 13 Mile Rd
Royal Oak, Michigan 48073
(248) 898-5000
William Beaumont Hospital-Royal Oak The largest Beaumont Hospital is located at 3601 W Thirteen Mile...
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mi
from
Royal Oak, MI
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