Resucitation Using Plasma-Adapted Hydroxyethyl Starch Solutions: Does it Make Difference as Regarding Coagulation Profile and Liver Functions when Compared with Conventional Saline Based Hydroxyethyl Starch Solutions?,
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- Category: Vol. 84, March 2016
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Resucitation Using Plasma-Adapted Hydroxyethyl Starch Solutions: Does it Make Difference as Regarding Coagulation Profile and Liver Functions when Compared with Conventional Saline Based Hydroxyethyl Starch Solutions?, AHMED H. ABD ALSALAM, AHMED M. MUKHTAR, NAZMY E. SEIF, ABEER A. MOHAMED and AMR H. SAYED
Abstract
Background: Several clinical studies have shown that Hydroxyethyl Starch (HES) may be as effective and safe as, but less expensive than, albumin when used for perioperative plasma volume replacement. The new third generation HES solution was designed to reduce Adverse Drug Reactions (ADRs) especialy the effect on coagulation and liver functions and improve safety while maintaining efficacy.
Methods: Our study included 40 patients who were sched-uled to radical prostatectomy or cystectomy with bladder replacement. Age above 18 years, sex males and females underwent radical cystectomy with bladder replacement, and males underwent radical prostatectomy. Patients were randomly allocated to receive either 6% HES 130/0.4 in NaCl 0.9% (Voluven, Fresenius Kabi, Bad Hom-bourg, Germany) or 6% HES 130/0.42 in a balanced electrolyte containing Na+ 140 mmol/L, Cl– 118 mmol/L, K +4 mmol/L, Ca++ 2.5 mmol/L, Mg++ 1mmol/L, acetate– 24mmol/L and malate– 5mmol/L (Tetraspan, B. Braun, Melsungen, Germany). This prospective, randomized, study was designed to prove therapeutic equiv-alence of both HES formulations. The primary outcome was the volume of the study drug in milliliters that will be needed for hemodynamic stabilization until the end of surgery. The effect on coagulation (INR) and liver functions (Bilrubin, ALT, AST, Albumin) and perioperative Hemoglobin as a secondary outcome in patients underwent radical prostatectomy or cystectomy with bladder replacement.
Results: 36 patients completed the study; 16 patients in the voluven group and 20 patients in the tetraspan group. Regarding the liver functions and coagulation profile (bilirubin, ALT, AST, Albumin, INR) there was no statistical significance between both groups. Regarding the hemoglobin there were no statistical significance between both groups but there were significant difference between the baseline hemoglobin (T1) and the hemoglobin at the end of surgery (T2) among the voluven group also there were significant differences between the baseline hemoglobin (T 1) and hemoglobin at both end of surgery (T2) and first day post-operative (T3) among the tetraspan group.
Conclusion: This study showed that both balanced 6% HES 130/0.4 (Tetraspan) and saline-based 6% HES 130/0.4 (Voluven) were equally effective for hemodynamic stabilization of patients undergoing major urologic procedures without any significant impact on coagulation and liver function tests.