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Efficacy, Safety of Hypertonic Lactate Soln. as Fluid Resuscitation Compared With Ringer's Lactate in Post-CABG Pats

NCT ID: NCT00529490

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

230 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-03-31

Study Completion Date

2003-06-30

Brief Summary

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Prospective, randomized, open-label study to assess the efficacy and safety of hypertonic lactate solution, compared to Ringer's Lactate as fluid resuscitation to maintain hemodynamic stability in post-coronary artery bypass grafting(CABG) patients. Patients who were eligible received either hypertonic lactate solution or Ringer's Lactate post-CABG in the ICU when fluid resuscitation was needed.

Detailed Description

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Prospective, randomized, open-label study to assess the efficacy and safety of hypertonic lactate solution, compared to Ringer's Lactate as fluid resuscitation to maintain hemodynamic stability in post-coronary artery bypass grafting(CABG) patients. Patients who were eligible received either hypertonic lactate solution or Ringer's Lactate post-CABG observed in the first 12 hours in the ICU when fluid resuscitation was needed.

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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HL

Hypertonic lactate group

Group Type EXPERIMENTAL

Hypertonic lactate

Intervention Type DRUG

Parenteral solution administered to a maximal volume of 10 ml/kg BW over the first 12 hours post-CABG

RL

Ringer's lactate

Group Type ACTIVE_COMPARATOR

Ringer's lactate

Intervention Type DRUG

Parenteral solution administered to a maximal dose of 30 ml/kg BW over the first 12 hours post-CABG

Interventions

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Hypertonic lactate

Parenteral solution administered to a maximal volume of 10 ml/kg BW over the first 12 hours post-CABG

Intervention Type DRUG

Ringer's lactate

Parenteral solution administered to a maximal dose of 30 ml/kg BW over the first 12 hours post-CABG

Intervention Type DRUG

Other Intervention Names

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Totilac

Eligibility Criteria

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Inclusion Criteria

* Patients who have given their written informed consent.
* Male or female, aged 18-75 years.
* Post-operative CABG on pump or off pump in ICU.
* Patients who need fluid resuscitation.

Exclusion Criteria

* Combined operations.
* Need for intra aortic balloon pump (IABP).
* Patients with severe arrhythmia (VT, AF rapid response, heart block).
* Severe hemodynamic imbalance.
* Severe bleeding and/or re-operation.
* Liver dysfunction(SGOT and SGPT 2x normal).
* Renal failure (Creatinine \>2 mg%).
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 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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Iqbal Mustafa, MD

Role: PRINCIPAL_INVESTIGATOR

National cardiac Centre, Harapan Kita Hospital, Dept. of Anaesthesiology, Intensive Care Unit, Jakarta, Indonesia

Xavier Leverve, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Director, INSERM-E0221-Bioenergetique Fondamentale et Appliquée Université, 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/CT-KB/DNA/02

Identifier Type: -

Identifier Source: org_study_id