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

Tracking Information

First Received Date ^ICMJE

September 28, 2005

Last Updated Date

February 1, 2010

Start Date ^ICMJE

October 2005

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00230412 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

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 ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case Control
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Retention: Samples With DNA

Description:

Whole blood, serum and urine.

Sampling Method

Non-Probability Sample

Study Population

Patients on paediatric intensive care units.

Condition ^ICMJE

Kidney Failure, Acute

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Not Provided

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

120

Estimated Completion Date

December 2010

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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).

Gender

Both

Ages

up to 18 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

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

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT00230412

Other Study ID Numbers ^ICMJE

HSP-233-05, Projektnummer 233-05

Has Data Monitoring Committee

Responsible Party

Dennis Ballwieser, LMU Munich

Study Sponsor ^ICMJE

University of Munich Children's Clinic

Collaborators ^ICMJE

Ludwig-Maximilians - University of Munich

Investigators ^ICMJE

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

Information Provided By

University of Munich Children's Clinic

Verification Date

January 2010

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

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