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

Innogene Kalbiotech

Status and phase

Completed

Phase 4

Conditions

Coronary Heart Disease

Treatments

Drug: 6% Hydroxy Ethyl Starch

Drug: Hypertonic sodium lactate

Study type

Interventional

Funder types

Industry

Identifiers

NCT01654653

LB.05.01.1.4.0.70

Details and patient eligibility

About

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).

Full 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.

Enrollment

100 patients

Sex

All

Ages

45 to 80 years old

Volunteers

No 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.