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

This study has been completed.
Sponsor:
Information provided by:
Innogene Kalbiotech Pte. Ltd
ClinicalTrials.gov Identifier:
NCT00529490
First received: September 12, 2007
Last updated: NA
Last verified: September 2007
History: No changes posted
  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: 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

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

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

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

ClinicalTrials.gov processed this record on April 16, 2014