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Completed

NCT Number: NCT00529490

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

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.

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Key information

Conditions

Low Cardiac Output Cardiac Output, Low Cardiovascular Diseases Heart Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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

Jakarta, Jakarta Special Capital Region, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%).

Treatment and study plan

Hypertonic lactate

Drug

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

Other names: Totilac

Ringer's Lactate

Drug

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

Primary outcomes

  1. hemodynamic stability

    Time frame: 12 hours post-CABG surgery

Secondary outcomes

  1. Safety of hypertonic sodium lactate for maintaining the hemodynamic stability

    Time frame: 12 hours post-CABG surgery

Sponsors and collaborators

Lead sponsor

Innogene Kalbiotech Pte. Ltd

Industry

Registry information

Official study 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

Important dates

Study start
2002
Study completion
2003
First posted
Sep 14, 2007
Registry last updated
Sep 14, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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