Back to resultsEfficacy, Safety of Hypertonic Lactate Soln. as Fluid Resuscitation Compared With Ringer's Lactate in Post-CABG Pats
Primary Purpose
Low Cardiac Output
Status
Completed
Phase
Phase 3
Locations
Indonesia
Study Type
Interventional
Intervention
Hypertonic lactate
Ringer's lactate
Sponsored by
About this trial
This is an interventional treatment trial for Low Cardiac Output focused on measuring coronary, artery, bypass, grafting, I.V., cardiac output
Eligibility 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%).
Sites / Locations
- National Cardiac Center, Department of Surgery and Intensive Care Unit, Harapan Kita Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
HL
RL
Arm Description
Hypertonic lactate group
Ringer's lactate
Outcomes
Primary Outcome Measures
hemodynamic stability
Secondary Outcome Measures
Safety of hypertonic sodium lactate for maintaining the hemodynamic stability
Full Information
NCT ID
NCT00529490
First Posted
September 12, 2007
Last Updated
September 12, 2007
Sponsor
Innogene Kalbiotech Pte. Ltd
1. Study Identification
Unique Protocol Identification Number
NCT00529490
Brief Title
Efficacy, Safety of Hypertonic Lactate Soln. as Fluid Resuscitation Compared With Ringer's Lactate in Post-CABG Pats
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2007
Overall Recruitment Status
Completed
Study Start Date
March 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2003 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Innogene Kalbiotech Pte. Ltd
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Cardiac Output
Keywords
coronary, artery, bypass, grafting, I.V., cardiac output
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
230 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HL
Arm Type
Experimental
Arm Description
Hypertonic lactate group
Arm Title
RL
Arm Type
Active Comparator
Arm Description
Ringer's lactate
Intervention Type
Drug
Intervention Name(s)
Hypertonic lactate
Other Intervention Name(s)
Totilac
Intervention Description
Parenteral solution administered to a maximal volume of 10 ml/kg BW over the first 12 hours post-CABG
Intervention Type
Drug
Intervention Name(s)
Ringer's lactate
Intervention Description
Parenteral solution administered to a maximal dose of 30 ml/kg BW over the first 12 hours post-CABG
Primary Outcome Measure Information:
Title
hemodynamic stability
Time Frame
12 hours post-CABG surgery
Secondary Outcome Measure Information:
Title
Safety of hypertonic sodium lactate for maintaining the hemodynamic stability
Time Frame
12 hours post-CABG surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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%).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Iqbal Mustafa, MD
Organizational Affiliation
National cardiac Centre, Harapan Kita Hospital, Dept. of Anaesthesiology, Intensive Care Unit, Jakarta, Indonesia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xavier Leverve, MD, PhD
Organizational Affiliation
Director, INSERM-E0221-Bioenergetique Fondamentale et Appliquée Université, Joseph Fourier, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cardiac Center, Department of Surgery and Intensive Care Unit, Harapan Kita Hospital
City
Jakarta
Country
Indonesia
12. IPD Sharing Statement
Learn more about this trial
Efficacy, Safety of Hypertonic Lactate Soln. as Fluid Resuscitation Compared With Ringer's Lactate in Post-CABG Pats
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