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Use of Two Modern Hydroxyethyl Starch Solutions in Major Urological Procedures

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ClinicalTrials.gov Identifier: NCT01670604
Recruitment Status : Unknown
Verified August 2012 by Ahmed Mukhtar, Kasr El Aini Hospital.
Recruitment status was:  Recruiting
First Posted : August 22, 2012
Last Update Posted : August 22, 2012
Sponsor:
Information provided by (Responsible Party):
Ahmed Mukhtar, Kasr El Aini Hospital

Brief 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.

Condition or disease Intervention/treatment 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  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Official Title: The Use of Two Modern Hydroxyethyl Starch Solutions in Major Urological Procedures: Effect on Acid-Base Status and Renal Functions
Study Start Date : January 2012
Estimated Primary Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Tests
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 ]
    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 :
  1. Acid base and Renal function [ Time Frame: 24 hours after randomization ]
    differences in the plasma creatinine concentrations and acid-base homeostasis among the study groups



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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