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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

August 5, 2012
August 20, 2012
January 2012
March 2013   (final data collection date for primary outcome measure)
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).
Same as current
Complete list of historical versions of study NCT01670604 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Use of Two Modern Hydroxyethyl Starch Solutions in Major Urological Procedures
The Use of Two Modern Hydroxyethyl Starch Solutions in Major Urological Procedures: Effect on Acid-Base Status and Renal Functions

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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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
  • Experimental: VOL group
    patients will receive 6% HES 130/0.4 in NaCl 0.9% (Voluven, Fresenius Kabi, Bad Hom-bourg, Germany)
    Intervention: 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
    Intervention: Drug: Tetraspan, B. Braun, Melsungen, Germany

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
Not Provided
March 2013   (final data collection date for primary outcome measure)

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).
Both
18 Years to 80 Years
No
Contact: Amr Hussein, MSc 01069338998 ext +2 amrhussein1981@hotmail.com
Contact: Ahmed Mukhtar, MD 01114208444 ext +2 Ahmed.Mukhtar@kasralainy.edu.eg
Egypt
 
NCT01670604
KAH012
Yes
Ahmed Mukhtar, Kasr El Aini Hospital
Kasr El Aini Hospital
Not Provided
Not Provided
Kasr El Aini Hospital
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP