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

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ClinicalTrials.gov Identifier: NCT00230412
Recruitment Status : Unknown
Verified January 2010 by University of Munich Children's Clinic.
Recruitment status was:  Recruiting
First Posted : September 30, 2005
Last Update Posted : February 2, 2010
Sponsor:
Collaborator:
Ludwig-Maximilians - University of Munich
Information provided by:
University of Munich Children's Clinic

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.

Condition or disease
Kidney Failure, Acute

Detailed 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.


Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Study of Heat Shock Proteins as Prognostic Factor of Acute Renal Failure in Children (HSP-Study)
Study Start Date : October 2005
Estimated Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock




Primary Outcome Measures :
  1. Acute renal failure. [ Time Frame: 28 days ]

Biospecimen Retention:   Samples With DNA
Whole blood, serum and urine.


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients on paediatric intensive care units.
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00230412


Contacts
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

Locations
Germany
Klinikum Augsburg, II. Klinik für Kinder und Jugendliche Recruiting
Augsburg, Bavaria, Germany, 86156
Contact: Gernot Buheitel, Prof. Dr.    +49-821-400-3431    sekretariat@2.kk.augsburg-med.de   
Contact: Wilfried Schenk, Dr. med.    +49-821-400-3431    sekretariat@2.kk.augsburg-med.de   
Principal Investigator: Dennis A Ballwieser, cand. med.         
Kinderklinik Memmingen Recruiting
Memmingen, Bavaria, Germany, 87700
Contact: Martin Ries, Prof. Dr.    +49-8331-70-2300    info@kinderklinik-memmingen.de   
Principal Investigator: Dennis A Ballwieser, cand. med.         
Sub-Investigator: Benjamin Ackermann, cand. med.         
Klinikum der Universität München, Kinderklinik und Poliklinik im Dr. von Haunerschen Kinderspital Recruiting
Munich, Bavaria, Germany, 80337
Contact: Dennis A. Ballwieser, cand. med.    +49-89-5160-7813    dennis.ballwieser@med.uni-muenchen.de   
Contact: Judith Glöckner-Pagel, Dr. med.    +49-89-5160-7895    judith.gloeckner@med.uni-muenchen.de   
Principal Investigator: Dennis A. Ballwieser, cand. med.         
Principal Investigator: Judith Glöckner, Dr. med.         
Principal Investigator: Karl Reiter, Dr. med.         
Deutsches Herzzentrum München Not yet recruiting
Munich, Bavaria, Germany, 80636
Contact: Gunter Balling, M. D.    +49-89-1218 ext 3303    balling@dhm.mhn.de   
Principal Investigator: Dennis A Ballwieser, cand. med.         
Klinkum der Barmherzigen Brüder St. Hedwig Recruiting
Regensburg, Bavaria, Germany, 93049
Contact: Hugo Segerer, Prof. Dr.    +49-941-369-5401    kinderundjugendmedizin@barmherzige-regensburg.de   
Contact: Peter Schindler, Physician    +49-941-369-5401    kinderundjugendmedizin@barmherzige-regensburg.de   
Principal Investigator: Dennis A Ballwieser, cand. med.         
Kinderklinik Rosenheim Recruiting
Rosenheim, Bavaria, Germany, 83022
Contact: Torsten Uhlig, Dr. med.    +49-8031-3634-51    kinderklinik@kliro.de   
Contact: Wolfgang John, Dr. med.    +49-8031-3634-51    kinderklinik@kliro.de   
Principal Investigator: Dennis A Ballwieser, cand. med.         
Sponsors and Collaborators
University of Munich Children's Clinic
Ludwig-Maximilians - University of Munich
Investigators
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

Additional Information:
Publications:
Responsible Party: Dennis Ballwieser, LMU Munich
ClinicalTrials.gov Identifier: NCT00230412     History of Changes
Other Study ID Numbers: HSP-233-05
Projektnummer 233-05
First Posted: September 30, 2005    Key Record Dates
Last Update Posted: February 2, 2010
Last Verified: January 2010

Keywords provided by University of Munich Children's Clinic:
Kidney Failure, Acute
Acute Renal Failure
Kidney Failure
Heat-Shock Proteins
Children

Additional relevant MeSH terms:
Renal Insufficiency
Acute Kidney Injury
Kidney Diseases
Urologic Diseases