Suspended

The Use of Two Modern Hydroxyethyl Starch Solutions in Major Urological Procedures: Effect on Acid-Base Status and Renal Functions

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What is being tested

6% HES 130/0.4 in NaCl 0.9% (Voluven, Fresenius Kabi, Bad Hom-bourg, Germany)

+ Tetraspan, B. Braun, Melsungen, Germany

Drug
Who is being recruted

From 18 to 80 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Phase 4
Interventional
Study Start: January 2012
See protocol details

Summary

Principal SponsorKasr El Aini Hospital
Study ContactAmr Hussein, MScMore contacts
Last updated: August 22, 2012
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2012

Actual date on which the first participant was enrolled.

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.

NCT01670604
Principal SponsorKasr El Aini Hospital
Study ContactAmr Hussein, MScMore contacts
Last updated: August 22, 2012
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

40 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

3 inclusion criteria required to participate
ASA Í and ÍÍ
Age group above 18 years
Patients who will be scheduled to undergo radical prostatectomy or cystectomy with bladder replacement
4 exclusion criteria prevent from participating
A known allergy to HES
Coagulation disorders (INR > 1.5)
Renal insufficiency (serum creatinine of > 2.5 mg/dL)
Significant hepatic disease (liver function tests more than three times the upper limit of normal)

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
patients will receive 6% HES 130/0.4 in NaCl 0.9% (Voluven, Fresenius Kabi, Bad Hom-bourg, Germany)

Group II

Experimental
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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Kasralainy Hospital

Cairo, EgyptOpen Kasralainy Hospital in Google Maps
SuspendedOne Study Center