Use of Two Modern Hydroxyethyl Starch Solutions in Major Urological Procedures

This study is currently recruiting participants.

Verified August 2012 by Kasr El Aini Hospital

Sponsor:

Information provided by (Responsible Party):

Ahmed Mukhtar, Kasr El Aini Hospital

ClinicalTrials.gov Identifier:

NCT01670604

First received: August 5, 2012

Last updated: August 20, 2012

Last verified: August 2012

History of Changes

Purpose

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.

Condition	Intervention	Phase
Urologic Surgical Procedures	Drug: 6% HES 130/0.4 in NaCl 0.9% (Voluven, Fresenius Kabi, Bad Hom-bourg, Germany) Drug: Tetraspan, B. Braun, Melsungen, Germany	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject)
Official Title:	The Use of Two Modern Hydroxyethyl Starch Solutions in Major Urological Procedures: Effect on Acid-Base Status and Renal Functions

Resource links provided by NLM:

Drug Information available for: Hetastarch

U.S. FDA Resources

Further study details as provided by Kasr El Aini Hospital:

Primary Outcome Measures:

Intraoperative volume replacement therapy [ Time Frame: 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 ] [ Designated as safety issue: No ]
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:

Acid base and Renal function [ Time Frame: 24 hours after randomization ] [ Designated as safety issue: Yes ]
differences in the plasma creatinine concentrations and acid-base homeostasis among the study groups

Estimated Enrollment:	40
Study Start Date:	January 2012
Estimated Primary Completion Date:	March 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: VOL group patients will receive 6% HES 130/0.4 in NaCl 0.9% (Voluven, Fresenius Kabi, Bad Hom-bourg, Germany)	Drug: 6% HES 130/0.4 in NaCl 0.9% (Voluven, Fresenius Kabi, Bad Hom-bourg, Germany)
Experimental: TET group 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	Drug: Tetraspan, B. Braun, Melsungen, Germany

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01670604

Contacts

Contact: Amr Hussein, MSc	01069338998 ext +2	amrhussein1981@hotmail.com
Contact: Ahmed Mukhtar, MD	01114208444 ext +2	Ahmed.Mukhtar@kasralainy.edu.eg

Locations

Egypt
Kasralainy Hospital	Recruiting
Cairo, Egypt, 11559
Contact: Amr Hussein, MSc 01069338998 ext +2 amrhussein1981@hotmail.com
Sub-Investigator: Abeer Ahmed, MD
Sub-Investigator: Nazmy Seif, MD
Sub-Investigator: Ahmed Helmy, MD
Sub-Investigator: Ahmed Mukhtar, MD
Principal Investigator: Amr Hussein, MSc

Sponsors and Collaborators

Kasr El Aini Hospital

More Information

Publications:

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

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.

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.

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.

Responsible Party:	Ahmed Mukhtar, Assistant professor of anesthesia Cairo University, Kasr El Aini Hospital
ClinicalTrials.gov Identifier:	NCT01670604 History of Changes
Other Study ID Numbers:	KAH012
Study First Received:	August 5, 2012
Last Updated:	August 20, 2012
Health Authority:	Egypt: Ministry of Higher Education

Additional relevant MeSH terms:

Hetastarch
Plasma Substitutes
Blood Substitutes

Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013

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