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

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Design

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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

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

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

Biospecimen Retention:   Samples With DNA

Whole blood, serum and urine.

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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).

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Universität München/University of Munich 

City of Memmingen Children's Clinic 

City of Augsburg Clinic 

City of Rosenheim Clinic 

The Brothers of Mercy's Hospital at Regensburg 

Publications:

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

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

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

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.

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
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