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

Innogene Kalbiotech Pte. Ltd66 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Low Cardiac Output

Interventions

Hypertonic lactateDRUG

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.

Ringer's lactateDRUG

Eligibility

Sex: ALLMin age: 45 YearsMax age: 80 Years

Medical Language ↔ Plain English

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)

Locations (1)

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

Jakarta, Jakarta Special Capital Region, Indonesia

Outcomes

Primary Outcomes

Hemodynamic status

Time frame: During and 12 hours after CABG surgery

Secondary Outcomes

Safety of hypertonic sodium lactate for maintaining hemodynamic stability

Time frame: During and 12 hours after CABG surgery

Data from ClinicalTrials.gov

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