The Efficacy of Hypertonic Lactate Solution in CABG(Coronary Artery Bypass Grafting) Patients

Innogene Kalbiotech

Status and phase

Completed

Phase 3

Conditions

Low Cardiac Output

Treatments

Drug: Hypertonic lactate

Drug: Ringer's lactate

Study type

Interventional

Funder types

Industry

Identifiers

NCT00529711

001/IGK-KAL/DNA/04

Details and patient eligibility

About

Previous clinical trials with 11.2% Hypertonic Ringer's Lactate in post-operative CABG subjects have shown an increase in several cardiac performance parameters, with lesser volume of resuscitation fluid required to reach circulation volume, as compared to Sodium Chloride.It also does not cause hyperchloremic acidosis, which is of value in treating shock patients.

The primary objectives of this prospective, randomized, open-label trial are to evaluate the clinical efficacy of hypertonic lactate in comparison to Ringer's lactate to maintain hemodynamic stability in intra- and post-CABG subjects in relation to hemodynamic status and body fluid balance, as well as to assess its safety in terms of lab parameters and occurrence of adverse events.The secondary objectives are to evaluate comparative clinical efficacy of the two fluids in relation to reduction in concomitant drug utilization, duration of ventilator usage, length of stay in ICU as well as total duration of hospitalization and neurocognitive status upto a period of 1 year post-CABG.

Full description

Details provided in summary.

Enrollment

66 patients

Sex

All

Ages

45 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male or female
45 to 80 years
CABG patients with on or off pump procedure
Ejection fraction < 50%
Given informed consent

Exclusion criteria

Combined operations
Severe arrhythmia(VT, AF rapid response, heart blocks) and severe hemodynamic imbalance
Severe bleeding and/or re-operation
Hypernatremia > 155 mMol/L
Severe liver failure(SGOT, SGPT 2x normal)
Severe renal failure(Creatinine > 2 mg. %)
Major diseases(eg. cancer)