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NCT00230412 Clinical Trial

Study of Heat Shock Proteins as Prognostic Factor of Acute Renal Failure in Children (HSP-Study)

Kidney Failure, Acute Clinical Trial

— HSP  

Official title:
Study of Heat Shock Proteins as Prognostic Factor of Acute Renal Failure in Children (HSP-Study)

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00230412
Other study ID # HSP-233-05
Secondary ID Projektnummer 23
Status Recruiting
Phase N/A
First received September 28, 2005
Last updated February 1, 2010
Start date October 2005
Est. completion date December 2010

Study information
Verified date January 2010
Source University of Munich Children's Clinic
Contact Dennis A. Ballwieser, cand. med.
Phone +49-89-2621-7564
Email dennis.ballwieser@med.uni-muenchen.de
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Observational

Clinical Trial 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.

Description:

A prognostic factor for the development of acute renal failure (ANR) in children would be very valuable for therapy regulation. So-called chaperones out of the family of heat shock proteins (HSP) are promising candidates which are involved in the development of ANR as well. This could be a starting point for the development of new therapeutic approaches.

ANR occurs in up to 50 percent of all critical ill patients and has a high rate of morbidity and mortality despite advances in symptomatic therapy. Following severe sepsis, septic shock or other shocks, combined with multiple organ failure, the ANR is an autonomous prognosis worsening factor.

Should the results of our study show a correlation between the production of HSP and the outcome of children with ANR, further studies would be required, to examine the pathophysiological relevance of HSP in ANR. We would then be able to determine a high risk population for ANR. A modulation of ANR therapy might be a result of further studies.

Recruitment information / eligibility
Status Recruiting
Enrollment 120
Est. completion date December 2010
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A to 18 Years
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- Existing affection of the kidney.

- Kidney transplantation.

- Missing written consent of the parents or guardian (if applicable).

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Germany Klinikum Augsburg, II. Klinik für Kinder und Jugendliche Augsburg Bavaria
Germany Kinderklinik Memmingen Memmingen Bavaria
Germany Deutsches Herzzentrum München Munich Bavaria
Germany Klinikum der Universität München, Kinderklinik und Poliklinik im Dr. von Haunerschen Kinderspital Munich Bavaria
Germany Klinkum der Barmherzigen Brüder St. Hedwig Regensburg Bavaria
Germany Kinderklinik Rosenheim Rosenheim Bavaria

Sponsors (2)
Lead Sponsor Collaborator
University of Munich Children's Clinic Ludwig-Maximilians - University of Munich

Country where clinical trial is conducted

Germany, 

References & Publications (4)

Lameire N, Van Biesen W, Vanholder R. Acute renal failure. Lancet. 2005 Jan 29-Feb 4;365(9457):417-30. Review. — View Citation

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. — View Citation

Schrier RW, Wang W. Acute renal failure and sepsis. N Engl J Med. 2004 Jul 8;351(2):159-69. Review. — View Citation

Thadhani R, Pascual M, Bonventre JV. Acute renal failure. N Engl J Med. 1996 May 30;334(22):1448-60. Review. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Acute renal failure. 28 days No
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