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

Low Cardiac Output Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00529711
• Other study ID #: 001/IGK-KAL/DNA/04
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2007
• Last updated: September 12, 2007
• Start date: July 2005
• Est. completion date: July 2006

Study information

• Verified date: September 2007
• Source: Innogene Kalbiotech Pte. Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Indonesia:BPOM
• Study type: Interventional

Clinical Trial 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.

Description:

Details provided in summary.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 80 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiac Output, Low
• Low Cardiac Output

Intervention

Drug:
• Hypertonic lactate
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.
• Ringer's lactate
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.

Locations

Country	Name	City	State
Indonesia	National Cardiac Center, Department of Surgery and Intensive Care Unit, Harapan Kita Hospital	Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Innogene Kalbiotech Pte. Ltd

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemodynamic status		During and 12 hours after CABG surgery
Secondary	Safety of hypertonic sodium lactate for maintaining hemodynamic stability		During and 12 hours after CABG surgery