Trial | NCT00529490  Report issue

Title

Efficacy, Safety of Hypertonic Lactate Soln. as Fluid Resuscitation Compared With Ringer's Lactate in Post-CABG Pats
The Efficacy and Safety of Hypertonic Lactate Solution as Fluid Resuscitation Compared With Ringer's Lactate in Post-CABG (Coronary Artery Bypass Grafting) Patients

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    230
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.
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.
Study Started
Mar 31
2002
Study Completion
Jun 30
2003
Last Update
Sep 14
2007
Estimate

Drug Hypertonic lactate

Parenteral solution administered to a maximal volume of 10 ml/kg BW over the first 12 hours post-CABG

  • Other names: Totilac

Drug Ringer's lactate

Parenteral solution administered to a maximal dose of 30 ml/kg BW over the first 12 hours post-CABG

HL Experimental

Hypertonic lactate group

RL Active Comparator

Ringer's lactate

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%).
No Results Posted