Use of Two Modern Hydroxyethyl Starch Solutions in Major Urological Procedures

Kasr El Aini Hospital40 enrolled

Overview

This study compares the effect of infusion of two types of modern hydroxyethyl starch on the renal function and acid-base in patients undergoing urologic surgery.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

SINGLE

Enrollment

Conditions

Urologic Surgical Procedures

Interventions

6% HES 130/0.4 in NaCl 0.9% (Voluven, Fresenius Kabi, Bad Hom-bourg, Germany)DRUG

Tetraspan, B. Braun, Melsungen, GermanyDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age group above 18 years, * ASA І and ІІ, * Patients who will be scheduled to undergo radical prostatectomy or cystectomy with bladder replacement Exclusion Criteria: * A known allergy to HES, * Renal insufﬁciency (serum creatinine of \>2.5 mg/dL), * Signiﬁcant hepatic disease (liver function tests more than three times the upper limit of normal), * Coagulation disorders (INR \> 1.5).

Locations (1)

Kasralainy Hospital

Cairo, Egypt

RECRUITING

Outcomes

Primary Outcomes

Intraoperative volume replacement therapy

volume of the study drug in milliliters that will be needed for hemodynamic stabilization until the end of surgery (ie, the cumulative volume of the study drug in milliliters administered up to this time point).

Time frame: From randomization, for the duration of surgery and up to transfer from the operating room to the ICU or recovery room, an expected average of 6 hours

Secondary Outcomes

Acid base and Renal function

differences in the plasma creatinine concentrations and acid-base homeostasis among the study groups

Time frame: 24 hours after randomization

Central Contacts

Amr Hussein, MSc

CONTACT

01069338998 amrhussein1981@hotmail.com

Ahmed Mukhtar, MD

CONTACT

01114208444 Ahmed.Mukhtar@kasralainy.edu.eg

Data from ClinicalTrials.gov

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