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.

Study Overview

• Status: Unknown
• Conditions: Urologic Surgical Procedures
• Intervention / Treatment: Drug: 6% HES 130/0.4 in NaCl 0.9% (Voluven, Fresenius Kabi, Bad Hom-bourg, Germany); Drug: Tetraspan, B. Braun, Melsungen, Germany

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11559
    • Recruiting
    • Kasralainy Hospital
    • Contact: Amr Hussein, MSc; Phone Number: +2 01069338998; Email: 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acid base and Renal function	differences in the plasma creatinine concentrations and acid-base homeostasis among the study groups	24 hours after randomization

Collaborators and Investigators

• Sponsor: Kasr El Aini Hospital

Publications and helpful links

General 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. doi: 10.1016/0049-3848(77)90058-5. No abstract available.
• 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. doi: 10.1254/jjp.27.314. No abstract available.
• 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. doi: 10.1021/ja00439a041. No abstract available.
• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Anticipated): March 1, 2013

Study Registration Dates

• First Submitted: August 5, 2012
• First Submitted That Met QC Criteria: August 20, 2012
• First Posted (Estimate): August 22, 2012

Study Record Updates

• Last Update Posted (Estimate): August 22, 2012
• Last Update Submitted That Met QC Criteria: August 20, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Other Study ID Numbers: KAH012