NCT00230412

Brief Summary

The purpose of the investigators' study is to determine whether the production of heat shock proteins has an effect on the development and the outcome of acute renal failure in children.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2005

Longer than P75 for all trials

Geographic Reach
1 country

6 active sites

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

First Submitted

Initial submission to the registry

September 28, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 30, 2005

Completed
1 day until next milestone

Study Start

First participant enrolled

October 1, 2005

Completed
5.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

February 2, 2010

Status Verified

January 1, 2010

First QC Date

September 28, 2005

Last Update Submit

February 1, 2010

Conditions

Kidney Failure, Acute

Keywords

Kidney Failure, AcuteAcute Renal FailureKidney FailureHeat-Shock ProteinsChildren

Outcome Measures

Primary Outcomes (1)

  • Acute renal failure.

    28 days

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients on paediatric intensive care units.

You may qualify if:

  • Between 0 and 18 years of age.
  • Either severe sepsis, shock of any origin or asphyxia.
  • Operated patients with operative or post-operative transfusion requirement of at least 0.5 x 80 ml/kg body weight of erythrocyte concentrate.

You may not qualify if:

  • Existing affection of the kidney.
  • Kidney transplantation.
  • Missing written consent of the parents or guardian (if applicable).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Klinikum Augsburg, II. Klinik für Kinder und Jugendliche

Augsburg, Bavaria, 86156, Germany

RECRUITING

Kinderklinik Memmingen

Memmingen, Bavaria, 87700, Germany

RECRUITING

Klinikum der Universität München, Kinderklinik und Poliklinik im Dr. von Haunerschen Kinderspital

Munich, Bavaria, 80337, Germany

RECRUITING

Deutsches Herzzentrum München

Munich, Bavaria, 80636, Germany

NOT YET RECRUITING

Klinkum der Barmherzigen Brüder St. Hedwig

Regensburg, Bavaria, 93049, Germany

RECRUITING

Kinderklinik Rosenheim

Rosenheim, Bavaria, 83022, Germany

RECRUITING

Related Publications (4)

  • Lameire N, Van Biesen W, Vanholder R. Acute renal failure. Lancet. 2005 Jan 29-Feb 4;365(9457):417-30. doi: 10.1016/S0140-6736(05)17831-3.

    PMID: 15680458BACKGROUND

  • Schrier RW, Wang W. Acute renal failure and sepsis. N Engl J Med. 2004 Jul 8;351(2):159-69. doi: 10.1056/NEJMra032401. No abstract available.

    PMID: 15247356BACKGROUND

  • Thadhani R, Pascual M, Bonventre JV. Acute renal failure. N Engl J Med. 1996 May 30;334(22):1448-60. doi: 10.1056/NEJM199605303342207. No abstract available.

    PMID: 8618585BACKGROUND

  • Schiffl H, Lang SM, Fischer R. Daily hemodialysis and the outcome of acute renal failure. N Engl J Med. 2002 Jan 31;346(5):305-10. doi: 10.1056/NEJMoa010877.

    PMID: 11821506BACKGROUND

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, serum and urine.

MeSH Terms

Conditions

Acute Kidney InjuryRenal Insufficiency

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Karl Reiter, Dr. med.

    Klinikum der Universität München, Kinderklinik und Poliklinik im Dr. von Haunerschen Kinderspital

    STUDY CHAIR

  • Judith Glöckner-Pagel, Dr. med.

    Klinikum der Universität München, Kinderklinik und Poliklinik im Dr. von Haunerschen Kinderspital

    STUDY DIRECTOR

  • Dennis A. Ballwieser, cand. med.

    Klinikum der Universität München, Kinderklinik und Poliklinik im Dr. von Haunerschen Kinderspital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dennis A. Ballwieser, cand. med.

CONTACT

+49-89-2621-7564dennis.ballwieser@med.uni-muenchen.de

Judith Glöckner-Pagel, Dr. med.

CONTACT

+49-89-5160-2811judith.gloeckner@med.uni-muenchen.de

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 28, 2005

First Posted

September 30, 2005

Study Start

October 1, 2005

Study Completion

December 1, 2010

Last Updated

February 2, 2010

Record last verified: 2010-01

Locations

DE(6)