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

Sponsor

Innogene Kalbiotech Pte. Ltd (Industry)

Overall Status

Completed

CT.gov ID

NCT01654653

Collaborator

(none)

100

Enrollment

Location

Arms

Duration (Months)

12.5

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Coronary Heart Disease	Drug: Hypertonic sodium lactate Drug: 6% Hydroxy Ethyl Starch	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Jul 1, 2008

Actual Primary Completion Date :

Mar 1, 2009

Actual Study Completion Date :

Mar 1, 2009

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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: 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).
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: Lab parameters: Hb, HCT, Na,K, Cl, Mg, lactate, glucose, and arterial blood gas. Adverse events

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.