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

Phase 4

Completed

• Conditions: Coronary Heart Disease
• Interventions: Drug: Hypertonic sodium lactate; Drug: 6% Hydroxy Ethyl Starch

• Registration Number: NCT01654653
• Lead Sponsor: Innogene Kalbiotech Pte. Ltd

Brief Summary

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

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.

Study Timeline

• Study Start: 2008-07
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Study First Submitted: 2012-05-03
• Status Verified: 2012-07
• Study First Submitted QC: 2012-07-27
• Last Update Submitted: 2012-07-27
• Study First Posted: 2012-08-01
• Last Update Posted: 2012-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HSL(Totilac)	Hypertonic sodium lactate	Hypertonic Sodium Lactate
6% HES (Voluven)	6% Hydroxy Ethyl Starch	6% Hydroxyethyl Starch

Primary Outcome Measures

Name	Time	Method
Efficacy	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	• Evaluation of efficacy of Hypertonic Sodium Lactate against 6% HES to maintain hemodynamic stability in intra CABG patients: 1. Hemodynamic status (CI, MAP, PVR/PVRI, SVR/SVRI, CVP, PAM, PAW, HR).; 2. 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).
Safety	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	Assess safety of HSL in intra CABG patients: 1. Lab parameters: Hb, HCT, Na,K, Cl, Mg, lactate, glucose, and arterial blood gas.; 2. Adverse events

Trial Locations

Locations (1)

National Cardiovascular Center Harapan Kita; 🇮🇩 Jakarta, Indonesia