Urologic Surgical Procedures
Conditions
Brief summary
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.
Interventions
DRUG6% HES 130/0.4 in NaCl 0.9% (Voluven, Fresenius Kabi, Bad Hom-bourg, Germany)
DRUGTetraspan, B. Braun, Melsungen, Germany
Sponsors
Kasr El Aini Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative volume replacement therapy | 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 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acid base and Renal function | 24 hours after randomization | differences in the plasma creatinine concentrations and acid-base homeostasis among the study groups |
Countries
Egypt
Contacts
Primary ContactAmr Hussein, MSc
Backup ContactAhmed Mukhtar, MD
Outcome results
None listed