Efficacy and Safety of Hypertonic Sodium Lactate Solution Compared With 6% HES Solution in CABG Patients
|Coronary Heart Disease||Drug: Hypertonic sodium lactate Drug: 6% Hydroxy Ethyl Starch||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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|
- Efficacy [ Time Frame: 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 [ Time Frame: 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
|Study Start Date:||July 2008|
|Study Completion Date:||March 2009|
|Primary Completion Date:||March 2009 (Final data collection date for primary outcome measure)|
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 Name: 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 Name: Voluven
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01654653
|National Cardiovascular Center Harapan Kita|
|Jakarta, Indonesia, 11420|
|Principal Investigator:||Cindy E Boom, PhD, MD||National Cardiovascular Center Harapan Kita, Indonesia|