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

NCT00529711 | Completed Phase 3

• 1 other identifier: 001/IGK-KAL/DNA/04
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Cardiac Output

Keywords

coronary; artery; bypass; grafting; IV; cardiac output

Outcome Measures

Primary Outcomes (1)

• Hemodynamic status

  During and 12 hours after CABG surgery

Secondary Outcomes (1)

• Safety of hypertonic sodium lactate for maintaining hemodynamic stability

  During and 12 hours after CABG surgery

Study Arms (2)

Group 1

EXPERIMENTAL

Hypertonic lactate

Drug: Hypertonic lactate

Group 2

ACTIVE COMPARATOR

Ringer's lactate

Drug: Ringer's lactate

Interventions

Hypertonic lactate DRUG

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.

Also known as: Totilac

Group 1

Ringer's lactate DRUG

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.

Group 2

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Innogene Kalbiotech Pte. Ltd: lead

Study Sites (1)

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

Jakarta, Jakarta Special Capital Region, 114210, Indonesia

Location

MeSH Terms

Conditions

Cardiac Output, Low

Interventions

Ringer's Lactate

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Xavier Leverve, MD, PhD

  Director, INSERM-E0221-Bioenergetique Fondamentale et appliquee, Universite Joseph Fourier, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 12, 2007
• First Posted: September 14, 2007
• Study Start: July 1, 2005
• Study Completion: July 1, 2006
• Last Updated: September 14, 2007

Record last verified: 2007-09

Locations

ID (1)