search
Back to results

The Efficacy of Hypertonic Lactate Solution in CABG(Coronary Artery Bypass Grafting) Patients

Primary Purpose

Low Cardiac Output

Status
Completed
Phase
Phase 3
Locations
Indonesia
Study Type
Interventional
Intervention
Hypertonic lactate
Ringer's lactate
Sponsored by
Innogene Kalbiotech Pte. Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Cardiac Output focused on measuring coronary, artery, bypass, grafting, IV, cardiac output

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female
  • 45 to 80 years
  • CABG patients with on or off pump procedure
  • Ejection fraction < 50%
  • Given informed consent

Exclusion Criteria:

  • Combined operations
  • Severe arrhythmia(VT, AF rapid response, heart blocks) and severe hemodynamic imbalance
  • Severe bleeding and/or re-operation
  • Hypernatremia > 155 mMol/L
  • Severe liver failure(SGOT, SGPT 2x normal)
  • Severe renal failure(Creatinine > 2 mg. %)
  • Major diseases(eg. cancer)

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

Group 1

Group 2

Arm Description

Hypertonic lactate

Ringer's lactate

Outcomes

Primary Outcome Measures

Hemodynamic status

Secondary Outcome Measures

Safety of hypertonic sodium lactate for maintaining hemodynamic stability

Full Information

First Posted
September 12, 2007
Last Updated
September 12, 2007
Sponsor
Innogene Kalbiotech Pte. Ltd
search

1. Study Identification

Unique Protocol Identification Number
NCT00529711
Brief Title
The Efficacy of Hypertonic Lactate Solution in CABG(Coronary Artery Bypass Grafting) Patients
Official Title
The Efficacy of Hypertonic Lactate Solution in CABG(Coronary Artery Bypass Grafting) Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2007
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Innogene Kalbiotech Pte. Ltd

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Previous clinical trials with 11.2% Hypertonic Ringer's Lactate in post-operative CABG subjects have shown an increase in several cardiac performance parameters, with lesser volume of resuscitation fluid required to reach circulation volume, as compared to Sodium Chloride.It also does not cause hyperchloremic acidosis, which is of value in treating shock patients. The primary objectives of this prospective, randomized, open-label trial are to evaluate the clinical efficacy of hypertonic lactate in comparison to Ringer's lactate to maintain hemodynamic stability in intra- and post-CABG subjects in relation to hemodynamic status and body fluid balance, as well as to assess its safety in terms of lab parameters and occurrence of adverse events.The secondary objectives are to evaluate comparative clinical efficacy of the two fluids in relation to reduction in concomitant drug utilization, duration of ventilator usage, length of stay in ICU as well as total duration of hospitalization and neurocognitive status upto a period of 1 year post-CABG.
Detailed Description
Details provided in summary.

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, IV, cardiac output

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
Hypertonic lactate
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
Ringer's lactate
Intervention Type
Drug
Intervention Name(s)
Hypertonic lactate
Other Intervention Name(s)
Totilac
Intervention Description
Solution given parenterally as follows: Intraoperative 3 ml./kg BW for 15 minutes at beginning of surgery; During surgery 1.5 ml/kg BW/hour; Second loading 1.5 ml/kg BW for 15 minutes after protamin administration; Post-operative 1 ml/kg BW/hour for 12 hours.
Intervention Type
Drug
Intervention Name(s)
Ringer's lactate
Intervention Description
Solution given parenterally as follows: Intraoperative 3 ml./kg BW for 15 minutes at beginning of surgery; During surgery 1.5 ml/kg BW/hour; Second loading 1.5 ml/kg BW for 15 minutes after protamin administration; Post-operative 1 ml/kg BW/hour for 12 hours.
Primary Outcome Measure Information:
Title
Hemodynamic status
Time Frame
During and 12 hours after CABG surgery
Secondary Outcome Measure Information:
Title
Safety of hypertonic sodium lactate for maintaining hemodynamic stability
Time Frame
During and 12 hours after CABG surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female 45 to 80 years CABG patients with on or off pump procedure Ejection fraction < 50% Given informed consent Exclusion Criteria: Combined operations Severe arrhythmia(VT, AF rapid response, heart blocks) and severe hemodynamic imbalance Severe bleeding and/or re-operation Hypernatremia > 155 mMol/L Severe liver failure(SGOT, SGPT 2x normal) Severe renal failure(Creatinine > 2 mg. %) Major diseases(eg. cancer)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xavier Leverve, MD, PhD
Organizational Affiliation
Director, INSERM-E0221-Bioenergetique Fondamentale et appliquee, Universite 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
ZIP/Postal Code
114210
Country
Indonesia

12. IPD Sharing Statement

Learn more about this trial

The Efficacy of Hypertonic Lactate Solution in CABG(Coronary Artery Bypass Grafting) Patients

We'll reach out to this number within 24 hrs