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

NCT ID: NCT00230412

Last Updated: 2010-02-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-10-31

Study Completion Date

2010-12-31

Brief Summary

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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

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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.

Conditions

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Kidney Failure, Acute

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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).
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ludwig-Maximilians - University of Munich

OTHER

Sponsor Role collaborator

University of Munich Children's Clinic

OTHER

Sponsor Role lead

Responsible Party

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LMU Munich

Principal Investigators

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Karl Reiter, Dr. med.

Role: STUDY_CHAIR

Klinikum der Universität München, Kinderklinik und Poliklinik im Dr. von Haunerschen Kinderspital

Judith Glöckner-Pagel, Dr. med.

Role: STUDY_DIRECTOR

Klinikum der Universität München, Kinderklinik und Poliklinik im Dr. von Haunerschen Kinderspital

Dennis A. Ballwieser, cand. med.

Role: PRINCIPAL_INVESTIGATOR

Klinikum der Universität München, Kinderklinik und Poliklinik im Dr. von Haunerschen Kinderspital

Locations

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Klinikum Augsburg, II. Klinik für Kinder und Jugendliche

Augsburg, Bavaria, Germany

Site Status RECRUITING

Kinderklinik Memmingen

Memmingen, Bavaria, Germany

Site Status RECRUITING

Klinikum der Universität München, Kinderklinik und Poliklinik im Dr. von Haunerschen Kinderspital

Munich, Bavaria, Germany

Site Status RECRUITING

Deutsches Herzzentrum München

Munich, Bavaria, Germany

Site Status NOT_YET_RECRUITING

Klinkum der Barmherzigen Brüder St. Hedwig

Regensburg, Bavaria, Germany

Site Status RECRUITING

Kinderklinik Rosenheim

Rosenheim, Bavaria, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Dennis A. Ballwieser, cand. med.

Role: CONTACT

+49-89-2621-7564

Judith Glöckner-Pagel, Dr. med.

Role: CONTACT

+49-89-5160-2811

Facility Contacts

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Gernot Buheitel, Prof. Dr.

Role: primary

+49-821-400-3431

Wilfried Schenk, Dr. med.

Role: backup

+49-821-400-3431

Martin Ries, Prof. Dr.

Role: primary

+49-8331-70-2300

Dennis A. Ballwieser, cand. med.

Role: primary

+49-89-5160-7813

Judith Glöckner-Pagel, Dr. med.

Role: backup

+49-89-5160-7895

Gunter Balling, M. D.

Role: primary

+49-89-1218 ext. 3303

Hugo Segerer, Prof. Dr.

Role: primary

+49-941-369-5401

Peter Schindler, Physician

Role: backup

+49-941-369-5401

Torsten Uhlig, Dr. med.

Role: primary

+49-8031-3634-51

Wolfgang John, Dr. med.

Role: backup

+49-8031-3634-51

References

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Lameire N, Van Biesen W, Vanholder R. Acute renal failure. Lancet. 2005 Jan 29-Feb 4;365(9457):417-30. doi: 10.1016/S0140-6736(05)17831-3.

Reference Type BACKGROUND
PMID: 15680458 (View on PubMed)

Schrier RW, Wang W. Acute renal failure and sepsis. N Engl J Med. 2004 Jul 8;351(2):159-69. doi: 10.1056/NEJMra032401. No abstract available.

Reference Type BACKGROUND
PMID: 15247356 (View on PubMed)

Thadhani R, Pascual M, Bonventre JV. Acute renal failure. N Engl J Med. 1996 May 30;334(22):1448-60. doi: 10.1056/NEJM199605303342207. No abstract available.

Reference Type BACKGROUND
PMID: 8618585 (View on PubMed)

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. doi: 10.1056/NEJMoa010877.

Reference Type BACKGROUND
PMID: 11821506 (View on PubMed)

Related Links

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http://hauner.klinikum.uni-muenchen.de/

Dr. von Haunersches Kinderspital München/University of Munich Children's Clinic

http://www.lmu.de

Universität München/University of Munich

http://www.klinikum-augsburg.de

City of Augsburg Clinic

http://www.kliro.de

City of Rosenheim Clinic

http://www.barmherzige-regensburg.de

The Brothers of Mercy's Hospital at Regensburg

Other Identifiers

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Projektnummer 233-05

Identifier Type: -

Identifier Source: secondary_id

HSP-233-05

Identifier Type: -

Identifier Source: org_study_id

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