Use of Two Modern Hydroxyethyl Starch Solutions in Major Urological Procedures

This study is currently recruiting participants. (see Contacts and Locations)
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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