A Phase 4 interventional study of Hypertonic sodium lactate and 6% Hydroxy Ethyl Starch in Coronary Heart Disease, sponsored by Innogene Kalbiotech Pte. Ltd. Completed at 1 site in Indonesia. Open to participants aged 45 Years to 80 Years. Per ClinicalTrials.gov, last updated 2012-08-01.
Sponsored by Innogene Kalbiotech Pte. Ltd · Phase 4, Interventional, and Treatment
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).
The primary objectives of this prospective, randomized and open-label study are as follows:
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.
3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.
This study's enrollment of 100 is close to the median of 100 across 1,778 interventional studies indexed under Heart Diseases.
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Hypertonic Sodium Lactate
Drug: Hypertonic sodium lactate
6% Hydroxyethyl Starch
Drug: 6% Hydroxy Ethyl Starch
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.
Also known as: Totilac
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
Also known as: Voluven
Efficacy
• Evaluation of efficacy of Hypertonic Sodium Lactate against 6% HES to maintain hemodynamic stability in intra CABG patients: 1. Hemodynamic status (CI, MAP, PVR/PVRI, SVR/SVRI, CVP, PAM, PAW, HR). 2. 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).
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
Safety
Assess safety of HSL in intra CABG patients: 1. Lab parameters: Hb, HCT, Na,K, Cl, Mg, lactate, glucose, and arterial blood gas. 2. Adverse events
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
This study is completed, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.
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Innogene Kalbiotech Pte. Ltd