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Histidine-Tryptophan-Ketoglutarate Solution Versus Blood Cardioplegia in CABG

NCT04203680 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 320

Last updated 2020-05-07

No results posted yet for this study

Summary

Background: In cardiac surgery, myocardial protection is mandatory during cross clamp time followed by reperfusion. Use of cardioplegic solutions preserves myocardial energy stores, hindering electrolyte disturbances and acidosis during periods of myocardial ischemia. This study was designed to compare the efficacy and safety of Histidine-tryptophan-ketoglutarate (HTK) solution versus blood cardioplegia in coronary artery bypass graft surgery.

Methods: Three hundred and twenty patients were randomized into Histidine-tryptophan-ketoglutarate (HTK) group and blood cardioplegia group. Ventilation time, total bypass time, cross clamp time, length of ICU or hospital stay and the early postoperative outcomes were analysed.

Conditions

  • Cardioplegia Solution Adverse Reaction

Interventions

DRUG

HTK cardioplegic solution

30 ml/kg of HTK cardioplegic solution at 4°C through an antegrade fashion at an initial perfusion pressure of 80-100 mmHg

DRUG

blood cardioplegia

one liter of blood cardioplegia was given with the antegrade route at 30°C, or lower. Blood maintenance cardioplegia was repeated every 30-45mins

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Principal Investigators

  • Ayman shoeb · Ain Shams University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-25
Primary Completion
2020-03-31
Completion
2020-04-25

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04203680 on ClinicalTrials.gov