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

Sponsor:	Innogene Kalbiotech Pte. Ltd
Information provided by:	Innogene Kalbiotech Pte. Ltd
ClinicalTrials.gov Identifier:	NCT00529490

Purpose

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.

Condition	Intervention	Phase
Low Cardiac Output	Drug: Hypertonic lactate Drug: Ringer's lactate	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment
Official Title:	The Efficacy and Safety of Hypertonic Lactate Solution as Fluid Resuscitation Compared With Ringer's Lactate in Post-CABG (Coronary Artery Bypass Grafting) Patients

Resource links provided by NLM:

MedlinePlus related topics: Coronary Artery Bypass Surgery Heart Failure

Drug Information available for: Lactic acid Ammonium lactate Ringer's lactate

U.S. FDA Resources

Further study details as provided by Innogene Kalbiotech Pte. Ltd:

Primary Outcome Measures:

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

Secondary Outcome Measures:

Safety of hypertonic sodium lactate for maintaining the hemodynamic stability [ Time Frame: 12 hours post-CABG surgery ]

Enrollment:	230
Study Start Date:	March 2002
Study Completion Date:	June 2003

Arms	Assigned Interventions
HL: Experimental Hypertonic lactate group	Drug: Hypertonic lactate Parenteral solution administered to a maximal volume of 10 ml/kg BW over the first 12 hours post-CABG
RL: Active Comparator Ringer's lactate	Drug: Ringer's lactate Parenteral solution administered to a maximal dose of 30 ml/kg BW over the first 12 hours post-CABG

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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%).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00529490

Locations

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

Sponsors and Collaborators

Innogene Kalbiotech Pte. Ltd

Investigators

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

More Information

No publications provided

Study ID Numbers:	001/CT-KB/DNA/02
Study First Received:	September 12, 2007
Last Updated:	September 12, 2007
ClinicalTrials.gov Identifier:	NCT00529490 History of Changes
Health Authority:	Indonesia:BPOM

Keywords provided by Innogene Kalbiotech Pte. Ltd:

coronary
artery
bypass

grafting
I.V.
cardiac output

Additional relevant MeSH terms:

Signs and Symptoms
Heart Diseases
Cardiovascular Diseases
Cardiac Output, Low

ClinicalTrials.gov processed this record on November 27, 2009