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

Coronary Heart Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01654653
• Other study ID #: LB.05.01.1.4.0.70
• Status: Completed
• Phase: Phase 4
• First received: May 3, 2012
• Last updated: July 27, 2012
• Start date: July 2008
• Est. completion date: March 2009

Study information

• Verified date: July 2012
• Source: Innogene Kalbiotech Pte. Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Indonesia: National Agency of Drug and Food Control
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Myocardial Ischemia

Intervention

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.
• 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

Locations

Country	Name	City	State
Indonesia	National Cardiovascular Center Harapan Kita	Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Innogene Kalbiotech Pte. Ltd

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	Yes