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

Low Cardiac Output Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00529490
• Other study ID #: 001/CT-KB/DNA/02
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2007
• Last updated: September 12, 2007
• Start date: March 2002
• Est. completion date: June 2003

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

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: June 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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%).

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiac Output, Low
• Low Cardiac Output

Intervention

Drug:
• Hypertonic lactate
Parenteral solution administered to a maximal volume of 10 ml/kg BW over the first 12 hours post-CABG
• Ringer's lactate
Parenteral solution administered to a maximal dose of 30 ml/kg BW over the first 12 hours post-CABG

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 stability		12 hours post-CABG surgery
Secondary	Safety of hypertonic sodium lactate for maintaining the hemodynamic stability		12 hours post-CABG surgery