Official Title
The Efficacy of Hypertonic Lactate Solution in CABG(Coronary Artery Bypass Grafting) Patients
Phase
Phase 3Lead Sponsor
Innogene Kalbiotech Pte. LtdStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Low Cardiac OutputIntervention/Treatment
ringer's lactate lactic acid ...Study Participants
66Previous 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.
Details provided in summary.
Solution given parenterally as follows: Intraoperative 3 ml./kg BW for 15 minutes at beginning of surgery; During surgery 1.5 ml/kg BW/hour; Second loading 1.5 ml/kg BW for 15 minutes after protamin administration; Post-operative 1 ml/kg BW/hour for 12 hours.
Solution given parenterally as follows: Intraoperative 3 ml./kg BW for 15 minutes at beginning of surgery; During surgery 1.5 ml/kg BW/hour; Second loading 1.5 ml/kg BW for 15 minutes after protamin administration; Post-operative 1 ml/kg BW/hour for 12 hours.
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)
