The Efficacy of Hypertonic Lactate Solution in CABG(Coronary Artery Bypass Grafting) Patients
Information source: Innogene Kalbiotech Pte. Ltd
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Low Cardiac Output
Intervention: Hypertonic lactate (Drug); Ringer's lactate (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Innogene Kalbiotech Pte. Ltd Official(s) and/or principal investigator(s):
Xavier Leverve, MD, PhD, Principal Investigator, Affiliation: Director, INSERM-E0221-Bioenergetique Fondamentale et appliquee, Universite Joseph Fourier, France
Summary
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.
Clinical Details
Official title: The Efficacy of Hypertonic Lactate Solution in CABG(Coronary Artery Bypass Grafting) Patients
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Hemodynamic status
Secondary outcome: Safety of hypertonic sodium lactate for maintaining hemodynamic stability
Detailed description:
Details provided in summary.
Eligibility
Minimum age: 45 Years.
Maximum age: 80 Years.
Gender(s): Both.
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)
Locations and Contacts
National Cardiac Center, Department of Surgery and Intensive Care Unit, Harapan Kita Hospital, Jakarta 114210, Indonesia
Additional Information
Starting date: July 2005
Ending date: July 2006
Last updated: September 12, 2007
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