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

Sponsors and Collaborators:	University of Munich Children's Clinic Ludwig-Maximilians - University of Munich
Information provided by:	University of Munich Children's Clinic
ClinicalTrials.gov Identifier:	NCT00230412

Purpose

The purpose of our 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

MedlinePlus related topics: Kidney Failure

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case Control, Prospective
Official Title:	Study of Heat Shock Proteins as Prognostic Factor of Acute Renal Failure in Children (HSP-Study)

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

Biospecimen Description:

Whole blood, serum and urine.

Estimated Enrollment:	120
Study Start Date:	October 2005
Estimated Study Completion Date:	September 2008

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00230412

Contacts

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

Locations

Germany, Bavaria
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.
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 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 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.
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.

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:

Dr. von Haunersches Kinderspital München/University of Munich Children's Clinic This link exits the ClinicalTrials.gov site

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:

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. No abstract available.

Thadhani R, Pascual M, Bonventre JV. Acute renal failure. N Engl J Med. 1996 May 30;334(22):1448-60. Review. No abstract available.

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:	LMU Munich ( Dennis Ballwieser )
Study ID Numbers:	HSP-233-05, Projektnummer 233-05
Study First Received:	September 28, 2005
Last Updated:	December 6, 2007
ClinicalTrials.gov Identifier:	NCT00230412 History of Changes
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

Study placed in the following topic categories:

Renal Insufficiency
Urologic Diseases
Shock
Renal Insufficiency, Acute

Kidney Diseases
Kidney Failure, Acute
Kidney Failure

Additional relevant MeSH terms:

Renal Insufficiency
Urologic Diseases
Renal Insufficiency, Acute

Kidney Diseases
Kidney Failure, Acute
Kidney Failure

ClinicalTrials.gov processed this record on May 07, 2009