NCT00529711

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Innogene Kalbiotech Pte. Ltd · Industry
• Sex: All
• Age: 45 Years – 80 Years
• Healthy volunteers: Not accepted

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 description

Details provided in summary.

Conditions

• Low Cardiac Output

Interventions

Type	Name	Description
DRUG	Hypertonic lactate	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.
DRUG	Ringer's lactate	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.

Timeline

• Start date: 2005-07-01
• Completion: 2006-07-01
• First posted: 2007-09-14
• Last updated: 2007-09-14

Locations

1 site across 1 country: Indonesia