Use of Two Modern Hydroxyethyl Starch Solutions in Major Urological Procedures
Study Details
Study Description
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 |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Intraoperative volume replacement therapy [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
- Acid base and Renal function [24 hours after randomization]
differences in the plasma creatinine concentrations and acid-base homeostasis among the study groups
Eligibility Criteria
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Kasralainy Hospital | Cairo | Egypt | 11559 |
Sponsors and Collaborators
- Kasr El Aini Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- Kluft C, Jenks RL, Astrup T. Production of plasminogen actovatpr activity in factor XII-deficient plasma. Thromb Res. 1977 May;10(5):759-64.
- 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.
- 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.
- KAH012