Clinical Trial: Efficacy, Safety of Hypertonic Lactate Soln. as Fluid Resuscitation Compared With Ringer's Lactate in Post-CABG Pats

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

Official Title: The Efficacy and Safety of Hypertonic Lactate Solution as Fluid Resuscitation Compared With Ringer's Lactate in Post-CABG (Coronary Artery Bypass Grafting) Patients

Brief Summary: Prospective, randomized, open-label study to assess the efficacy and safety of hypertonic lactate solution, compared to Ringer's Lactate as fluid resuscitation to maintain hemodynamic stability in post-coronary artery bypass grafting(CABG) patients. Patients who were eligible received either hypertonic lactate solution or Ringer's Lactate post-CABG in the ICU when fluid resuscitation was needed.

Detailed Summary: Prospective, randomized, open-label study to assess the efficacy and safety of hypertonic lactate solution, compared to Ringer's Lactate as fluid resuscitation to maintain hemodynamic stability in post-coronary artery bypass grafting(CABG) patients. Patients who were eligible received either hypertonic lactate solution or Ringer's Lactate post-CABG observed in the first 12 hours in the ICU when fluid resuscitation was needed.
Sponsor: Innogene Kalbiotech Pte. Ltd

Current Primary Outcome: hemodynamic stability [ Time Frame: 12 hours post-CABG surgery ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Safety of hypertonic sodium lactate for maintaining the hemodynamic stability [ Time Frame: 12 hours post-CABG surgery ]

Original Secondary Outcome: Same as current

Information By: Innogene Kalbiotech Pte. Ltd

Dates:
Date Received: September 12, 2007
Date Started: March 2002
Date Completion:
Last Updated: September 12, 2007
Last Verified: September 2007