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

Phase 3

Completed

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

• Registration Number: NCT00529490
• Lead Sponsor: Innogene Kalbiotech Pte. Ltd

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 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.

Study Timeline

• Study Start: 2002-03
• Study Completion: 2003-06
• 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: 230

Inclusion Criteria

• Patients who have given their written informed consent.
• Male or female, aged 18-75 years.
• Post-operative CABG on pump or off pump in ICU.
• Patients who need fluid resuscitation.

Exclusion Criteria

• Combined operations.
• Need for intra aortic balloon pump (IABP).
• Patients with severe arrhythmia (VT, AF rapid response, heart block).
• Severe hemodynamic imbalance.
• Severe bleeding and/or re-operation.
• Liver dysfunction(SGOT and SGPT 2x normal).
• Renal failure (Creatinine >2 mg%).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HL	Hypertonic lactate	Hypertonic lactate group
RL	Ringer's lactate	Ringer's lactate

Primary Outcome Measures

Name	Time	Method
hemodynamic stability	12 hours post-CABG surgery

Secondary Outcome Measures

Name	Time	Method
Safety of hypertonic sodium lactate for maintaining the hemodynamic stability	12 hours post-CABG surgery

Trial Locations

Locations (1)

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