Histidine-Tryptophan-Ketoglutarate Solution Versus Blood Cardioplegia in CABG

NCT04203680 | Completed Early Phase 1 DMC

• 1 other identifier: FMASU R 61/ 2019
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (1)

• mortality rate

  mortality rate

  up to 30 days postoperative

Secondary Outcomes (3)

• Troponin I level

  Up to 24 hours postoperative

• length of ICU stay

  up to 3 days postoperative

• length of hospital stay

  up to 7 days postoperative

Study Arms (2)

HTK group

SHAM COMPARATOR

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

Drug: HTK cardioplegic solution

blood cardioplegia group

ACTIVE COMPARATOR

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

Drug: blood cardioplegia

Interventions

HTK cardioplegic solution DRUG

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

Also known as: Histidine-tryptophan-ketoglutarate solution

HTK group

blood cardioplegia DRUG

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

blood cardioplegia group

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age from 60-80 years old
• elective CABG
• no comorbidities

You may not qualify if:

• patients with Unstable angina
• Poor left ventricular function
• Patient with acute myocardial infarction
• previous renal failure
• Preoperative Aortic valve or Mitral valve disease requiring replacement

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (2)

Ain Shams university

Cairo, 11566, Egypt

Location

Ain Shams university

Cairo, Egypt

Location

MeSH Terms

Interventions

Bretschneider cardioplegic solution

Study Officials

• Ayman shoeb

  Ain Shams University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of Anaesthesiology

Study Record Dates

• First Submitted: December 16, 2019
• First Posted: December 18, 2019
• Study Start: December 25, 2019
• Primary Completion: March 31, 2020
• Study Completion: April 25, 2020
• Last Updated: May 7, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 4 months
• Access Criteria: Data were analyzed using SPSS Statistics version 23 (IBM© Corp., Armonk, NY, USA). Normally distributed numerical data were presented as mean and SD, and skewed data were presented as median and interquartile range. Qualitative data were presented as number and percentage or ratio. Normally distributed numerical data were compared using the unpaired t-test. Skewed numerical data were compared using the Mann-Whitney test and categorical data were compared using Fisher's exact test. P-value \< 0.05 were considered statistically significant.

Locations

EG (2)