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

Phase 3

Completed

• Conditions: Low Cardiac Output
• Interventions: Drug: Hypertonic lactate; Drug: Ringer's lactate

• Registration Number: NCT00529711
• Lead Sponsor: Innogene Kalbiotech Pte. Ltd

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 Description

Details provided in summary.

Study Timeline

• Study Start: 2005-07
• Study Completion: 2006-07
• Status Verified: 2007-09
• Study First Submitted: 2007-09-12
• Study First Submitted QC: 2007-09-12
• Last Update Submitted: 2007-09-12
• Study First Posted: 2007-09-14
• Last Update Posted: 2007-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Hypertonic lactate	Hypertonic lactate
Group 2	Ringer's lactate	Ringer's lactate

Primary Outcome Measures

Name	Time	Method
Hemodynamic status	During and 12 hours after CABG surgery

Secondary Outcome Measures

Name	Time	Method
Safety of hypertonic sodium lactate for maintaining hemodynamic stability	During and 12 hours after CABG surgery

Trial Locations

Locations (1)

National Cardiac Center, Department of Surgery and Intensive Care Unit, Harapan Kita Hospital; 🇮🇩 Jakarta, Indonesia