Use of Two Modern Hydroxyethyl Starch Solutions in Major Urological Procedures

Phase 4

• Conditions: Urologic Surgical Procedures
• Interventions: Drug: 6% HES 130/0.4 in NaCl 0.9% (Voluven, Fresenius Kabi, Bad Hom-bourg, Germany); Drug: Tetraspan, B. Braun, Melsungen, Germany

• Registration Number: NCT01670604
• Lead Sponsor: Kasr El Aini Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Status Verified: 2012-08
• Study First Submitted: 2012-08-05
• Study First Submitted QC: 2012-08-20
• Last Update Submitted: 2012-08-20
• Study First Posted: 2012-08-22
• Last Update Posted: 2012-08-22
• Primary Completion: 2013-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VOL group	6% HES 130/0.4 in NaCl 0.9% (Voluven, Fresenius Kabi, Bad Hom-bourg, Germany)	patients will receive 6% HES 130/0.4 in NaCl 0.9% (Voluven, Fresenius Kabi, Bad Hom-bourg, Germany)
TET group	Tetraspan, B. Braun, Melsungen, Germany	patient will receive 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++ 1 mmol/L, acetate- 24 mmol/L and malate-- 5 mmol/L

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Acid base and Renal function	24 hours after randomization	differences in the plasma creatinine concentrations and acid-base homeostasis among the study groups

Trial Locations

Locations (1)

Kasralainy Hospital; 🇪🇬 Cairo, Egypt