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

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Details provided in summary.

Study Type

Interventional

Enrollment (Actual)

66

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, 114210
        • 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

45 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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: Group 1
Hypertonic lactate
Drug: Hypertonic lactate

Solution given parenterally as follows:

Intraoperative 3 ml./kg BW for 15 minutes at beginning of surgery; During surgery 1.5 ml/kg BW/hour; Second loading 1.5 ml/kg BW for 15 minutes after protamin administration; Post-operative 1 ml/kg BW/hour for 12 hours.

Other Names:
  • Totilac
ACTIVE_COMPARATOR: Group 2
Ringer's lactate
Drug: Ringer's lactate

Solution given parenterally as follows:

Intraoperative 3 ml./kg BW for 15 minutes at beginning of surgery; During surgery 1.5 ml/kg BW/hour; Second loading 1.5 ml/kg BW for 15 minutes after protamin administration; Post-operative 1 ml/kg BW/hour for 12 hours.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hemodynamic status
Time Frame: During and 12 hours after CABG surgery
During and 12 hours after CABG surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety of hypertonic sodium lactate for maintaining hemodynamic stability
Time Frame: During and 12 hours after CABG surgery
During and 12 hours after 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: Xavier Leverve, MD, PhD, Director, INSERM-E0221-Bioenergetique Fondamentale et appliquee, Universite 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

July 1, 2005

Study Completion (ACTUAL)

July 1, 2006

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/IGK-KAL/DNA/04

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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