Efficacy and Safety of Hypertonic Sodium Lactate Solution Compared With 6% HES Solution in CABG Patients

Study Overview
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Brief Summary
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The choice of fluid therapy is controversial in cardiac surgery. Numerous studies have shown that colloid is better as compared to crystalloids. Several previous studies have demonstrated that Hypertonic Sodium Lactate (HSL) administration during cardiac surgery shows a promising effect. This study aims to compare hemodynamic effects and fluid balance of HSL with 6% Hydroxy Ethyl Starch (HES).

Detailed Description
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The primary objectives of this prospective, randomized and open-label study are as follows: To evaluate the clinical efficacy of Hypertonic Sodium Lactate (HSL) in comparison with 6% HES to maintain hemodynamic stability in intra CABG patients related to hemodynamic status and Body fluid balance. To assess the safety of HSL in intra CABG patients related to defined laboratory parameters clinical adverse events which occur during the trial. Subjects meeting enrolment criteria will be randomly assigned to HSL or 6%HES treatment groups. Assessment of comparability will be done by unpaired student t-test or Chi-Square test or by a two-way ANOVA for repeated measures followed by post-hoc analysis when significant difference is found within the two groups. The hypothesis tested is that HSL is effective in intra CABG surgery patients, requiring less volume with better cardiac index, as compared to 6% HES.

Official Title
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A Phase , Prospective, Randomized, Open-label Study to Compare the Efficacy and Safety of Hypertonic Sodium Lactate Solution Compared With 6% HES Solution in CABG (Coronary Artery Bypass Grafting) Patients

Conditions
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Coronary Heart Disease

Intervention / Treatment
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* Drug: Hypertonic sodium lactate
* Drug: 6% Hydroxy Ethyl Starch


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, aged 45-80 years. CABG patients with on or off pump procedure. Ejection fraction <50% Patients who have given their written informed consent. Exclusion Criteria: Combined operations(surgeries) Patients with severe arrhythmia (VT, AF rapid response, heart block) and severe hemodynamic imbalance. Severe bleeding and/or re-operation. Hypernatremia> 155 mmol/L Severe liver failure: SGOT and SGPT more than twice normal. Severe renal failure: creatinine more than 2 mg%. Patients with major diseases such as cancer, etc.

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: HSL(Totilac)<br>Hypertonic Sodium Lactate | Drug: Hypertonic sodium lactate<br>* Administered at beginning of surgery as loading dose at 3 mL/kg body weight within 15 minutes. Additional fluid administered if needed and this was was managed similarly in both groups; the types and amount of additional fluid was measured and recorded. Surgery procedure and concomitant medication was managed similarly.<br>* Other names: Totilac;|
| Active Comparator: 6% HES (Voluven)<br>6% Hydroxyethyl Starch | Drug: 6% Hydroxy Ethyl Starch<br>* Administered at beginning of surgery as loading dose at 3 mL/kgBW within 15 minutes. Additional fluid given if needed and this was managed similarly in both groups; the types and amount of additional fluid was measured and recorded. Surgery procedure and concomitant medication was managed similarly<br>* Other names: Voluven;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy | • Evaluation of efficacy of Hypertonic Sodium Lactate against 6% HES to maintain hemodynamic stability in intra CABG patients: Hemodynamic status (CI, MAP, PVR/PVRI, SVR/SVRI, CVP, PAM, PAW, HR). Body fluid balance (urinary output; total fluid loss including urine and hemorrhage; total fluid infusion including HSL and 6% HES, blood product and other fluids). | Assessed from baseline till upto end of surgery(mean duration of surgery was 372.47 ± 122.82 min in HSLgroup vs 380.61 ± 82.08 min in HES group | 
| Safety | Assess safety of HSL in intra CABG patients: Lab parameters: Hb, HCT, Na,K, Cl, Mg, lactate, glucose, and arterial blood gas. Adverse events | Assessed from baseline till upto end of surgery(mean duration of surgery was 372.47 ± 122.82 min in HSLgroup vs 380.61 ± 82.08 min in HES group | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart disease, cardiac surgery, CABG, Totilac, Voluven, 6% HES