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Completed

NCT Number: NCT01681095

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

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Heart Valve Diseases Myocardial Ischemia Valvular Heart Disease Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Custodiol HTK

Drug

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.

Other names: Histidine-tryptophan-ketoglutarate cardioplegia solution

cold blood cardioplegia

Drug

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.

Primary outcomes

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

    Time frame: Baseline and 7 hours post surgery

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

  2. Change in Troponin I

    Time frame: Baseline and 7 hours post surgery

    Troponin I values, difference from baseline 7 hours post surgery

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

    Time frame: Baseline and 24 hours post surgery

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

Secondary outcomes

  1. Cardiac Dysrhythmias

    Time frame: up to 36 hrs post surgery

    Number of participants with new or worsening of cardiac dysrhythmias

  2. All Cause Mortality

    Time frame: 30 days post procedure

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

  3. Cardiovascular Mortality

    Time frame: 30 days post procedure

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

  4. Time on Mechanically Assisted Ventilation

    Time frame: up to 36 hours post procedure

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

  5. Duration of Vasopressor / Inotropic Agent

    Time frame: up to 36 hours post procedure

    Total time in minutes on any vasopressor or inotropic agent, including norepinephrine, epinephrine, vasopressin, milrinone, dobutamine, dopamine and/or neo-synephrine

  6. Postoperative Inotropic Infusion >20 Minutes

    Time frame: during operative procedure

    Number of patients receiving vasopressor or inotropic infusion for greater than 20 minutes in the operating room, including norepinephrine, epinephrine, vasopressin, milrinone, dobutamine, dopamine and/or neo-synephrine.

  7. Intensive Care Unit (ICU) Length of Stay

    Time frame: up to 100 days after admission

    Duration of stay in ICU, from ICU admission to ICU discharge

  8. Myocardial Infarction

    Time frame: up to 36 hours post procedure

    Number or participants fulfilling at least two of the following 3 criteria: (1) CK-MB of 100 ug/L or more and/or troponin-I of 3.0 ug/L or more, (2) appearance of new postoperative Q waves on the EKG of more than 0.03 seconds, and (3) a new hypokinetic or akinetic area in the left or right ventricle by echocardiography.

  9. Biochemical Marker - Creatine Kinase MB Isoenzyme (CK-MB)

    Time frame: pre-operative

    CK-MB measured pre-operatively

  10. Biochemical Marker - Creatine Kinase MB Isoenzyme (CK-MB)

    Time frame: 24 hours post procedure

    CK-MB measured 24 hours post-operatively

  11. Biochemical Marker - Creatine Kinase MB Isoenzyme (CK-MB)

    Time frame: 48 hours post procedure

    CK-MB measured 48 hours post-operatively

  12. Cardiac Marker - Troponin-I

    Time frame: pre-operatively

    Troponin-I measured pre-operatively

  13. Cardiac Marker - Troponin-I

    Time frame: 24 hours post procedure

    Troponin-I measured 24 hours post-operative

  14. Cardiac Marker - Troponin-I

    Time frame: 48 hours post procedure

    Troponin-I measured 48 hours post-operative

Sponsors and collaborators

Lead sponsor

Marc Sakwa, MD

Other

Collaborators

  • Essential Pharmaceuticals, LLC

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2016
First posted
Sep 7, 2012
Registry last updated
Aug 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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