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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00529490
First Posted: September 14, 2007
Last Update Posted: September 14, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Innogene Kalbiotech Pte. Ltd
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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:


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
Experimental: HL
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
Other Name: Totilac
Active Comparator: RL
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00529490     History of Changes
Other Study ID Numbers: 001/CT-KB/DNA/02
First Submitted: September 12, 2007
First Posted: September 14, 2007
Last Update Posted: September 14, 2007
Last Verified: September 2007

Keywords provided by Innogene Kalbiotech Pte. Ltd:
coronary
artery
bypass
grafting
I.V.
cardiac output

Additional relevant MeSH terms:
Cardiac Output, Low
Heart Diseases
Cardiovascular Diseases
Signs and Symptoms