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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01670604
Other study ID # KAH012
Secondary ID
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. completion date
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


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
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