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

Study Overview
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Brief Summary
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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
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Details provided in summary.

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

Conditions
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Low Cardiac Output

Intervention / Treatment
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* Drug: Hypertonic lactate
* Drug: Ringer's lactate


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Hypertonic lactate | Drug: Hypertonic lactate<br>* 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.<br>* Other names: Totilac;|
| Active Comparator: Group 2<br>Ringer's lactate | Drug: Ringer's lactate<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemodynamic status |  | During and 12 hours after CABG surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of hypertonic sodium lactate for maintaining hemodynamic stability |  | During and 12 hours after CABG surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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artery, coronary, bypass, grafting, IV, cardiac output