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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | September 12, 2007 | ||||
| Last Updated Date | September 12, 2007 | ||||
| Start Date ICMJE | July 2005 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
Hemodynamic status [ Time Frame: During and 12 hours after CABG surgery ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
Safety of hypertonic sodium lactate for maintaining hemodynamic stability [ Time Frame: During and 12 hours after CABG surgery ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | The Efficacy of Hypertonic Lactate Solution in CABG(Coronary Artery Bypass Grafting) Patients | ||||
| Official Title ICMJE | The Efficacy of Hypertonic Lactate Solution in CABG(Coronary Artery Bypass Grafting) Patients | ||||
| Brief 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. |
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| Detailed Description | Details provided in summary. |
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| Study Phase | Phase III | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE | Low Cardiac Output | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups |
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| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 66 | ||||
| Completion Date | July 2006 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 45 Years to 80 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Indonesia | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00529711 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | 001/IGK-KAL/DNA/04 | ||||
| Study Sponsor ICMJE | Innogene Kalbiotech Pte. Ltd | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Innogene Kalbiotech Pte. Ltd | ||||
| Verification Date | September 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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