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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
History of Changes
  Purpose

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
Kidney Failure, Acute

Study Type: Observational
Study Design: 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)

Resource links provided by NLM:

MedlinePlus related topics: Shock
U.S. FDA Resources

Further study details as provided by University of Munich Children's Clinic:

Primary Outcome Measures:
  • Acute renal failure. [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Whole blood, serum and urine.
Estimated Enrollment: 120
Study Start Date: October 2005
Estimated Study Completion Date: December 2010
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.

  Eligibility
Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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.         
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.         
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.         
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

Additional Information:
Universität München/University of Munich  This link exits the ClinicalTrials.gov site
Homepage of the HSP-Study  This link exits the ClinicalTrials.gov site
City of Memmingen Children's Clinic  This link exits the ClinicalTrials.gov site
City of Augsburg Clinic  This link exits the ClinicalTrials.gov site
City of Rosenheim Clinic  This link exits the ClinicalTrials.gov site
The Brothers of Mercy's Hospital at Regensburg  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Dennis Ballwieser, LMU Munich
ClinicalTrials.gov Identifier: NCT00230412     History of Changes
Other Study ID Numbers: HSP-233-05, Projektnummer 233-05
Study First Received: September 28, 2005
Last Updated: February 1, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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:
Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on March 01, 2015