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

This study has been completed.
Sponsor:
Information provided by:
Innogene Kalbiotech Pte. Ltd
ClinicalTrials.gov Identifier:
NCT00529711
First received: September 12, 2007
Last updated: NA
Last verified: September 2007
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Low Cardiac Output
 Drug: Hypertonic lactate
Drug: Ringer's lactate
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Efficacy of Hypertonic Lactate Solution in CABG(Coronary Artery Bypass Grafting) Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Innogene Kalbiotech Pte. Ltd:

Primary Outcome Measures:
  • Hemodynamic status [ Time Frame: During and 12 hours after CABG surgery ]

Secondary Outcome Measures:
  • Safety of hypertonic sodium lactate for maintaining hemodynamic stability [ Time Frame: During and 12 hours after CABG surgery ]

Enrollment: 66
Study Start Date: July 2005
Study Completion Date: July 2006
Arms Assigned Interventions
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 Name: 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.

Detailed Description:

Details provided in summary.

  Eligibility

Ages Eligible for Study:   45 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00529711

Locations
Indonesia
National Cardiac Center, Department of Surgery and Intensive Care Unit, Harapan Kita Hospital
Jakarta, Indonesia, 114210
Sponsors and Collaborators
Innogene Kalbiotech Pte. Ltd
Investigators
Principal Investigator: Xavier Leverve, MD, PhD Director, INSERM-E0221-Bioenergetique Fondamentale et appliquee, Universite Joseph Fourier, France
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00529711     History of Changes
Other Study ID Numbers: 001/IGK-KAL/DNA/04
Study First Received: September 12, 2007
Last Updated: September 12, 2007
Health Authority: Indonesia:BPOM

Keywords provided by Innogene Kalbiotech Pte. Ltd:
coronary
artery
bypass
 grafting
IV
cardiac output

Additional relevant MeSH terms:
Cardiac Output, Low
Heart Diseases
Cardiovascular Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013