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

September 12, 2007 updated by: Innogene Kalbiotech Pte. Ltd

The Efficacy and Safety of Hypertonic Lactate Solution as Fluid Resuscitation Compared With Ringer's Lactate in Post-CABG (Coronary Artery Bypass Grafting) Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

230

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: HL
Hypertonic lactate group
Drug: Hypertonic lactate
Parenteral solution administered to a maximal volume of 10 ml/kg BW over the first 12 hours post-CABG
Other Names:
  • Totilac
ACTIVE_COMPARATOR: RL
Ringer's lactate
Drug: Ringer's lactate
Parenteral solution administered to a maximal dose of 30 ml/kg BW over the first 12 hours post-CABG

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
hemodynamic stability
Time Frame: 12 hours post-CABG surgery
12 hours post-CABG surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety of hypertonic sodium lactate for maintaining the hemodynamic stability
Time Frame: 12 hours post-CABG surgery
12 hours post-CABG surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Innogene Kalbiotech Pte. Ltd

Investigators

  • Principal Investigator: Iqbal Mustafa, MD, National cardiac Centre, Harapan Kita Hospital, Dept. of Anaesthesiology, Intensive Care Unit, Jakarta, Indonesia
  • Principal Investigator: Xavier Leverve, MD, PhD, Director, INSERM-E0221-Bioenergetique Fondamentale et Appliquée Université, Joseph Fourier, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2002

Study Completion (ACTUAL)

June 1, 2003

Study Registration Dates

First Submitted

September 12, 2007

First Submitted That Met QC Criteria

September 12, 2007

First Posted (ESTIMATE)

September 14, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

September 14, 2007

Last Update Submitted That Met QC Criteria

September 12, 2007

Last Verified

September 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 001/CT-KB/DNA/02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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