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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary:

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.

Detailed Summary: Details provided in summary.
Sponsor: Innogene Kalbiotech Pte. Ltd

Current Primary Outcome: Hemodynamic status [ Time Frame: During and 12 hours after CABG surgery ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Safety of hypertonic sodium lactate for maintaining hemodynamic stability [ Time Frame: During and 12 hours after CABG surgery ]

Original Secondary Outcome: Same as current

Information By: Innogene Kalbiotech Pte. Ltd

Dates:
Date Received: September 12, 2007
Date Started: July 2005
Date Completion:
Last Updated: September 12, 2007
Last Verified: September 2007