NCT01670604

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 5, 2012

Completed
17 days until next milestone

First Posted

Study publicly available on registry

August 22, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Last Updated

August 22, 2012

Status Verified

August 1, 2012

Enrollment Period

1.2 years

First QC Date

August 5, 2012

Last Update Submit

August 20, 2012

Conditions

Urologic Surgical Procedures

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Acid base and Renal function

    24 hours after randomization

Study Arms (2)

VOL group

EXPERIMENTAL

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)

TET group

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

Drug: Tetraspan, B. Braun, Melsungen, Germany

Interventions

6% HES 130/0.4 in NaCl 0.9% (Voluven, Fresenius Kabi, Bad Hom-bourg, Germany)DRUG
VOL group
Tetraspan, B. Braun, Melsungen, GermanyDRUG
TET group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age group above 18 years,
  • ASA І and ІІ,
  • Patients who will be scheduled to undergo radical prostatectomy or cystectomy with bladder replacement

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasralainy Hospital

Cairo, 11559, Egypt

RECRUITING

Related Publications (4)

  • 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.

    PMID: 18813BACKGROUND

  • 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.

    PMID: 18633BACKGROUND

  • 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.

    PMID: 10319BACKGROUND

  • 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.

    PMID: 21345BACKGROUND

MeSH Terms

Interventions

Hydroxyethyl Starch DerivativesHES 130-0.4

Intervention Hierarchy (Ancestors)

StarchDietary CarbohydratesCarbohydratesGlucansPolysaccharides

Central Study Contacts

Amr Hussein, MSc

CONTACT

01069338998amrhussein1981@hotmail.com

Ahmed Mukhtar, MD

CONTACT

01114208444Ahmed.Mukhtar@kasralainy.edu.eg

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor of anesthesia Cairo University

Study Record Dates

First Submitted

August 5, 2012

First Posted

August 22, 2012

Study Start

January 1, 2012

Primary Completion

March 1, 2013

Last Updated

August 22, 2012

Record last verified: 2012-08

Locations

EG(1)