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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

September 12, 2007
September 12, 2007
July 2005
Not Provided
Hemodynamic status [ Time Frame: During and 12 hours after CABG surgery ]
Same as current
No Changes Posted
Safety of hypertonic sodium lactate for maintaining hemodynamic stability [ Time Frame: During and 12 hours after CABG surgery ]
Same as current
Not Provided
Not Provided
 
The Efficacy of Hypertonic Lactate Solution in CABG(Coronary Artery Bypass Grafting) Patients
The Efficacy of Hypertonic Lactate Solution in CABG(Coronary Artery Bypass Grafting) Patients

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.

Details provided in summary.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Low Cardiac Output
  • 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
  • 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.

  • Experimental: Group 1
    Hypertonic lactate
    Intervention: Drug: Hypertonic lactate
  • Active Comparator: Group 2
    Ringer's lactate
    Intervention: Drug: Ringer's lactate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
66
July 2006
Not Provided

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)
Both
45 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Indonesia
 
NCT00529711
001/IGK-KAL/DNA/04
No
Not Provided
Innogene Kalbiotech Pte. Ltd
Not Provided
Principal Investigator: Xavier Leverve, MD, PhD Director, INSERM-E0221-Bioenergetique Fondamentale et appliquee, Universite Joseph Fourier, France
Innogene Kalbiotech Pte. Ltd
September 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP