Low Cardiac Output Clinical Trial
Official title:
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.
Details provided in summary. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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