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

This study has been completed.
Sponsor:
Information provided by:
Innogene Kalbiotech Pte. Ltd
ClinicalTrials.gov Identifier:
NCT00529490
First received: September 12, 2007
Last updated: NA
Last verified: September 2007
History: No changes posted

September 12, 2007
September 12, 2007
March 2002
Not Provided
hemodynamic stability [ Time Frame: 12 hours post-CABG surgery ]
Same as current
No Changes Posted
Safety of hypertonic sodium lactate for maintaining the hemodynamic stability [ Time Frame: 12 hours post-CABG surgery ]
Same as current
Not Provided
Not Provided
 
Efficacy, Safety of Hypertonic Lactate Soln. as Fluid Resuscitation Compared With Ringer's Lactate in Post-CABG Pats
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.

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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Low Cardiac Output
  • Drug: Hypertonic lactate
    Parenteral solution administered to a maximal volume of 10 ml/kg BW over the first 12 hours post-CABG
    Other Name: Totilac
  • Drug: Ringer's lactate
    Parenteral solution administered to a maximal dose of 30 ml/kg BW over the first 12 hours post-CABG
  • Experimental: HL
    Hypertonic lactate group
    Intervention: Drug: Hypertonic lactate
  • Active Comparator: RL
    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
230
June 2003
Not Provided

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%).
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Indonesia
 
NCT00529490
001/CT-KB/DNA/02
No
Not Provided
Innogene Kalbiotech Pte. Ltd
Not Provided
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
Innogene Kalbiotech Pte. Ltd
September 2007

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