Cardioplegia Solution Adverse Reaction Clinical Trial
Official title:
Efficacy of Histidine-Tryptophan-Ketoglutarate Solution Versus Blood Cardioplegia in Coronary Artery Bypass Graft Surgery: A Randomized Double Blinded Study
Verified date | May 2020 |
Source | Ain Shams University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 320 |
Est. completion date | April 25, 2020 |
Est. primary completion date | March 31, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 60 Years to 80 Years |
Eligibility |
Inclusion Criteria: - age from 60-80 years old - elective CABG - no comorbidities Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Egypt | Ain Shams university | Cairo | |
Egypt | Ain Shams university | Cairo |
Lead Sponsor | Collaborator |
---|---|
Ain Shams University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | mortality rate | mortality rate | up to 30 days postoperative | |
Secondary | Troponin I level | level of troponin in the blood | Up to 24 hours postoperative | |
Secondary | length of ICU stay | ICU stay duration | up to 3 days postoperative | |
Secondary | length of hospital stay | hospital stay duration | up to 7 days postoperative |
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