Phase 2
Completed N=110
Custodiol-HTK (Histidine-tryptophan-ketoglutarate) Solution as a Cardioplegic Agent
Source: ClinicalTrials.gov NCT01681095 ↗Enrolled (actual)
110
Serious AEs
10.9%
Results posted
Mar 2017
Primary outcomePrimary: Change in Creatine Phosphokinase-MB Isoenzyme (CK-MB) — 18.8; 22.2 ng/mL
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Creatine Phosphokinase-MB Isoenzyme (CK-MB) |
18.8; 22.2 | — |
| PRIMARY Change in Troponin I |
9.65; 10.15 | — |
| PRIMARY Changes in Left Ventricular (LV) Ejection Fraction (EF) by Transthoracic Echocardiogram (TTE) |
-0.06; 1.9 | — |
| SECONDARY Cardiac Dysrhythmias |
24; 30 | — |
| SECONDARY All Cause Mortality |
0; 0 | — |
| SECONDARY Cardiovascular Mortality |
0; 0 | — |
| SECONDARY Time on Mechanically Assisted Ventilation |
10.5; 11.4 | — |
| SECONDARY Duration of Vasopressor / Inotropic Agent |
340; 582 | — |
| SECONDARY Postoperative Inotropic Infusion >20 Minutes |
47; 43 | — |
| SECONDARY Intensive Care Unit (ICU) Length of Stay |
3; 3 | — |
| SECONDARY Myocardial Infarction |
0; 0 | — |
| SECONDARY Biochemical Marker - Creatine Kinase MB Isoenzyme (CK-MB) |
6.0; 7.8 | — |
| SECONDARY Biochemical Marker - Creatine Kinase MB Isoenzyme (CK-MB) |
6.0; 7.8 | — |
| SECONDARY Biochemical Marker - Creatine Kinase MB Isoenzyme (CK-MB) |
6.0; 7.8 | — |
| SECONDARY Cardiac Marker - Troponin-I |
3.0; 4.8 | — |
| SECONDARY Cardiac Marker - Troponin-I |
3.0; 4.8 | — |
| SECONDARY Cardiac Marker - Troponin-I |
3.0; 4.8 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01681095). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.