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Completed

NCT Number: NCT00529711

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

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.

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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

45 year–80 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, 114210, Indonesia

About this study

Details provided in summary.

Who can participate

Healthy volunteers accepted: No

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

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)

Treatment and study plan

Hypertonic lactate

Drug

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.

Other names: Totilac

Ringer's Lactate

Drug

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.

Primary outcomes

  1. Hemodynamic status

    Time frame: During and 12 hours after CABG surgery

Secondary outcomes

  1. Safety of hypertonic sodium lactate for maintaining hemodynamic stability

    Time frame: During and 12 hours after CABG surgery

Sponsors and collaborators

Lead sponsor

Innogene Kalbiotech Pte. Ltd

Industry

Registry information

Important dates

Study start
2005
Study completion
2006
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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