Use of Two Modern Hydroxyethyl Starch Solutions in Major Urological Procedures

NCT ID: NCT01670604

Last Updated: 2012-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Urologic Surgical Procedures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Participants

Study Groups

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VOL group

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

Group Type EXPERIMENTAL

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

Intervention Type DRUG

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

Group Type EXPERIMENTAL

Tetraspan, B. Braun, Melsungen, Germany

Intervention Type DRUG

Interventions

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

Intervention Type DRUG

Tetraspan, B. Braun, Melsungen, Germany

Intervention Type DRUG

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kasr El Aini Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Mukhtar

Assistant professor of anesthesia Cairo University

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kasralainy Hospital

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Amr Hussein, MSc

Role: CONTACT

Phone: 01069338998

Email: [email protected]

Ahmed Mukhtar, MD

Role: CONTACT

Phone: 01114208444

Email: [email protected]

Facility Contacts

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Amr Hussein, MSc

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 18813 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18633 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10319 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21345 (View on PubMed)

Other Identifiers

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KAH012

Identifier Type: -

Identifier Source: org_study_id