Clinical trial NCT01654653: Efficacy and Safety of Hypertonic Sodium Lactate Solution Compared With 6% HES Solution in CABG Patients
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Heart Disease
Keywords: Heart disease
cardiac surgery
CABG
Totilac
Voluven
6% HES
Lead sponsor: Innogene Kalbiotech Pte. Ltd
Sponsor class: INDUSTRY
First posted: 2012-08-01
Enrollment: 100
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Efficacy
timeFrame: 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
measure: Safety
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: National Cardiovascular Center Harapan Kita
Study officials:
affiliation: National Cardiovascular Center Harapan Kita, Indonesia
name: Cindy E Boom, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References: