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

NCT ID: NCT01654653

Last Updated: 2012-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2009-03-31

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.

Conditions

Coronary Heart Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HSL(Totilac)

Hypertonic Sodium Lactate

Group Type: EXPERIMENTAL

Hypertonic sodium lactate

Intervention Type: DRUG

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% HES (Voluven)

6% Hydroxyethyl Starch

Group Type: ACTIVE_COMPARATOR

6% Hydroxy Ethyl Starch

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

Totilac; Voluven

Eligibility Criteria

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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Innogene Kalbiotech Pte. Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cindy E Boom, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

National Cardiovascular Center Harapan Kita, Indonesia

Locations

National Cardiovascular Center Harapan Kita

Jakarta, Jakarta Special Capital Region, Indonesia

Countries

Indonesia

Other Identifiers

LB.05.01.1.4.0.70

Identifier Type: -

Identifier Source: org_study_id