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

• Status: Completed
• Trial end date: 2003-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Innogene Kalbiotech Pte. Ltd

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%).