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

Information source: Innogene Kalbiotech Pte. Ltd
ClinicalTrials.gov processed this data on August 23, 2015
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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

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
Last updated: September 12, 2007

Page last updated: August 23, 2015

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