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| Sponsor: | Innogene Kalbiotech Pte. Ltd |
|---|---|
| Information provided by: | Innogene Kalbiotech Pte. Ltd |
| ClinicalTrials.gov Identifier: | NCT00529711 |
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 III |
| 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 |
| 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. |
Details provided in summary.
Eligibility| Ages Eligible for Study: | 45 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Indonesia | |
| National Cardiac Center, Department of Surgery and Intensive Care Unit, Harapan Kita Hospital | |
| Jakarta, Indonesia, 114210 | |
| Principal Investigator: | Xavier Leverve, MD, PhD | Director, INSERM-E0221-Bioenergetique Fondamentale et appliquee, Universite Joseph Fourier, France |
More Information
| 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 |
|
coronary artery bypass |
grafting IV cardiac output |
|
Cardiac Output, Low Heart Diseases Cardiovascular Diseases Signs and Symptoms |
