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

Condition(s) targeted: Low Cardiac Output

Intervention: Hypertonic lactate (Drug); Ringer's lactate (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Innogene Kalbiotech Pte. Ltd

Official(s) and/or principal investigator(s):
Iqbal Mustafa, MD, Principal Investigator, Affiliation: National cardiac Centre, Harapan Kita Hospital, Dept. of Anaesthesiology, Intensive Care Unit, Jakarta, Indonesia
Xavier Leverve, MD, PhD, Principal Investigator, Affiliation: Director, INSERM-E0221-Bioenergetique Fondamentale et Appliquée Université, Joseph Fourier, France

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.

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

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment

Primary outcome: hemodynamic stability

Secondary outcome: Safety of hypertonic sodium lactate for maintaining the hemodynamic stability

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.

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

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%).

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

Starting date: March 2002
Ending date: June 2003
Last updated: September 12, 2007