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

Tracking Information

First Received Date ^ICMJE

September 12, 2007

Last Updated Date

September 12, 2007

Start Date ^ICMJE

March 2002

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

hemodynamic stability [ Time Frame: 12 hours post-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 the hemodynamic stability [ Time Frame: 12 hours post-CABG surgery ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

The Efficacy and Safety of Hypertonic Lactate Solution as Fluid Resuscitation Compared With Ringer's Lactate in Post-CABG (Coronary Artery Bypass Grafting) Patients

Brief Summary

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

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment

Condition ^ICMJE

Low Cardiac Output

Intervention ^ICMJE

Drug: Hypertonic lactate
Drug: Ringer's lactate

Study Arms / Comparison Groups

Experimental: Hypertonic lactate group
Active Comparator: Ringer's lactate

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

230

Completion Date

June 2003

Primary Completion Date

Eligibility Criteria ^ICMJE

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%).

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Indonesia

Administrative Information

NCT ID ^ICMJE

NCT00529490

Responsible Party

Study ID Numbers ^ICMJE

001/CT-KB/DNA/02

Study Sponsor ^ICMJE

Innogene Kalbiotech Pte. Ltd

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:	Iqbal Mustafa, MD	National cardiac Centre, Harapan Kita Hospital, Dept. of Anaesthesiology, Intensive Care Unit, Jakarta, Indonesia
Principal Investigator:	Xavier Leverve, MD, PhD	Director, INSERM-E0221-Bioenergetique Fondamentale et Appliquée Université, Joseph Fourier, France

Information Provided By

Innogene Kalbiotech Pte. Ltd

Verification Date

September 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP