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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by University of Munich Children's Clinic.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Ludwig-Maximilians - University of Munich
Information provided by:
University of Munich Children's Clinic
ClinicalTrials.gov Identifier:
NCT00230412
First received: September 28, 2005
Last updated: February 1, 2010
Last verified: January 2010

September 28, 2005
February 1, 2010
October 2005
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Acute renal failure. [ Time Frame: 28 days ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00230412 on ClinicalTrials.gov Archive Site
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Study of Heat Shock Proteins as Prognostic Factor of Acute Renal Failure in Children (HSP-Study)
Study of Heat Shock Proteins as Prognostic Factor of Acute Renal Failure in Children (HSP-Study)

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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
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Retention:   Samples With DNA
Description:

Whole blood, serum and urine.

Non-Probability Sample

Patients on paediatric intensive care units.

Kidney Failure, Acute
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
December 2010
Not Provided

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).
Both
up to 18 Years
No
Contact: Dennis A. Ballwieser, cand. med. +49-89-2621-7564 dennis.ballwieser@med.uni-muenchen.de
Contact: Judith Glöckner-Pagel, Dr. med. +49-89-5160-2811 judith.gloeckner@med.uni-muenchen.de
Germany
 
NCT00230412
HSP-233-05, Projektnummer 233-05
No
Dennis Ballwieser, LMU Munich
University of Munich Children's Clinic
Ludwig-Maximilians - University of Munich
Study Chair: Karl Reiter, Dr. med. Klinikum der Universität München, Kinderklinik und Poliklinik im Dr. von Haunerschen Kinderspital
Study Director: Judith Glöckner-Pagel, Dr. med. Klinikum der Universität München, Kinderklinik und Poliklinik im Dr. von Haunerschen Kinderspital
Principal Investigator: Dennis A. Ballwieser, cand. med. Klinikum der Universität München, Kinderklinik und Poliklinik im Dr. von Haunerschen Kinderspital
University of Munich Children's Clinic
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP