Use of Two Modern Hydroxyethyl Starch Solutions in Major Urological Procedures

Urologic Surgical Procedures Clinical Trial

Official title:

The Use of Two Modern Hydroxyethyl Starch Solutions in Major Urological Procedures: Effect on Acid-Base Status and Renal Functions

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01670604
• Other study ID #: KAH012
• Status: Recruiting
• Phase: Phase 4
• First received: August 5, 2012
• Last updated: August 20, 2012
• Start date: January 2012

Study information

• Verified date: August 2012
• Source: Kasr El Aini Hospital
• Contact: Amr Hussein, MSc
• Phone: 01069338998
• Email: amrhussein1981[@]hotmail.com
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Age group above 18 years,

• ASA ? and ??,

• Patients who will be scheduled to undergo radical prostatectomy or cystectomy with bladder replacement

Exclusion Criteria:

• A known allergy to HES,

• Renal insuf?ciency (serum creatinine of >2.5 mg/dL),

• Signi?cant hepatic disease (liver function tests more than three times the upper limit of normal),

• Coagulation disorders (INR > 1.5).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Urologic Surgical Procedures

Intervention

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

• Tetraspan, B. Braun, Melsungen, Germany

Locations

Country	Name	City	State
Egypt	Kasralainy Hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Kasr El Aini Hospital

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

Birke ER. [On the action of antihypotensive agents in sympathicotonic orthostatic hypotension in geriartric patients: comparison between placebo and etilefrin (author's transl)]. Med Klin. 1977 Oct 14;72(41):1696-702. German. — View Citation

Kluft C, Jenks RL, Astrup T. Production of plasminogen actovatpr activity in factor XII-deficient plasma. Thromb Res. 1977 May;10(5):759-64. — View Citation

Mitchell AR, Erickson BW, Ryabtsev MN, Hodges RS, Merrifield RB. Tert-butoxycarbonylaminoacyl-4-(oxymethyl)-phenylacetamidomethyl-resin, a more acid-resistant support for solid-phase peptide synthesis. J Am Chem Soc. 1976 Nov 10;98(23):7357-62. — View Citation

Takayanagi I, Maruyama M, Takagi K. Beta-adrenoceptors in the guinea pig treated with egg-albumin. Jpn J Pharmacol. 1977 Apr;27(2):314-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	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	No
Secondary	Acid base and Renal function	differences in the plasma creatinine concentrations and acid-base homeostasis among the study groups	24 hours after randomization	Yes