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

NCT00529490 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 230

Last updated 2007-09-14

No results posted yet for this study

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.

Conditions

  • Low Cardiac Output

Interventions

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

Sponsors & Collaborators

  • Innogene Kalbiotech Pte. Ltd

    lead INDUSTRY

Principal Investigators

  • Iqbal Mustafa, MD · National cardiac Centre, Harapan Kita Hospital, Dept. of Anaesthesiology, Intensive Care Unit, Jakarta, Indonesia

  • Xavier Leverve, MD, PhD · Director, INSERM-E0221-Bioenergetique Fondamentale et Appliquée Université, Joseph Fourier, France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-03-31
Completion
2003-06-30

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00529490 on ClinicalTrials.gov