NCT00529490

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 230 (actual)
• Sponsor: Innogene Kalbiotech Pte. Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Low Cardiac Output

Interventions

Type	Name	Description
DRUG	Hypertonic lactate	Parenteral solution administered to a maximal volume of 10 ml/kg BW over the first 12 hours post-CABG
DRUG	Ringer's lactate	Parenteral solution administered to a maximal dose of 30 ml/kg BW over the first 12 hours post-CABG

Timeline

• Start date: 2002-03-01
• Completion: 2003-06-01
• First posted: 2007-09-14
• Last updated: 2007-09-14

Locations

1 site across 1 country: Indonesia