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

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

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).

Study Overview

• Status: Completed
• Conditions: Coronary Heart Disease
• Intervention / Treatment: Drug: Hypertonic sodium lactate; Drug: 6% Hydroxy Ethyl Starch

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• Indonesia
  • Jakarta, Indonesia, 11420
    • National Cardiovascular Center Harapan Kita

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: HSL(Totilac); Hypertonic Sodium Lactate	Drug: Hypertonic sodium lactate; 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.; Other Names: Totilac
ACTIVE_COMPARATOR: 6% HES (Voluven); 6% Hydroxyethyl Starch	Drug: 6% Hydroxy Ethyl Starch; 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; Other Names: Voluven

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Innogene Kalbiotech Pte. Ltd
• Investigators: Principal Investigator: Cindy E Boom, PhD, MD, National Cardiovascular Center Harapan Kita, Indonesia

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (ACTUAL): March 1, 2009
• Study Completion (ACTUAL): March 1, 2009

Study Registration Dates

• First Submitted: May 3, 2012
• First Submitted That Met QC Criteria: July 27, 2012
• First Posted (ESTIMATE): August 1, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): August 1, 2012
• Last Update Submitted That Met QC Criteria: July 27, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Keywords: cardiac surgery; CABG; Heart disease; Voluven; Totilac; 6% HES
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: LB.05.01.1.4.0.70