Low Cardiac Output
Conditions
Keywords
coronary, artery, bypass, grafting, IV, cardiac output
Brief summary
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.
Detailed description
Details provided in summary.
Interventions
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.
DRUGRinger's lactate
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.
Sponsors
Innogene Kalbiotech Pte. Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to 80 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hemodynamic status | During and 12 hours after CABG surgery |
Secondary
| Measure | Time frame |
|---|---|
| Safety of hypertonic sodium lactate for maintaining hemodynamic stability | During and 12 hours after CABG surgery |
Countries
Indonesia
Outcome results
None listed