Use of Two Modern Hydroxyethyl Starch Solutions in Major Urological Procedures

Kasr El Aini Hospital

Status and phase: Unknown; Phase 4

Conditions: Urologic Surgical Procedures

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01670604

KAH012

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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).

Trial design

40 participants in 2 patient groups

VOL group

Experimental group

Description:

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

Treatment:

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

TET group

Experimental group

Description:

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

Treatment:

Drug: Tetraspan, B. Braun, Melsungen, Germany