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

NCT ID: NCT00529711

Last Updated: 2007-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2006-07-31

Brief Summary

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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.

Detailed Description

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Details provided in summary.

Conditions

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Low Cardiac Output

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group 1

Hypertonic lactate

Group Type EXPERIMENTAL

Hypertonic lactate

Intervention Type DRUG

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.

Group 2

Ringer's lactate

Group Type ACTIVE_COMPARATOR

Ringer's lactate

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Totilac

Eligibility Criteria

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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)
Minimum Eligible Age

45 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Innogene Kalbiotech Pte. Ltd

INDUSTRY

Sponsor Role lead

Principal Investigators

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Xavier Leverve, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Director, INSERM-E0221-Bioenergetique Fondamentale et appliquee, Universite Joseph Fourier, France

Locations

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National Cardiac Center, Department of Surgery and Intensive Care Unit, Harapan Kita Hospital

Jakarta, Jakarta Special Capital Region, Indonesia

Site Status

Countries

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Indonesia

Other Identifiers

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001/IGK-KAL/DNA/04

Identifier Type: -

Identifier Source: org_study_id