Clinical trial NCT00230412: Study of Heat Shock Proteins as Prognostic Factor of Acute Renal Failure in Children (HSP-Study)
Official title: Study of Heat Shock Proteins as Prognostic Factor of Acute Renal Failure in Children (HSP-Study)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Kidney Failure, Acute
Keywords: Kidney Failure, Acute
Acute Renal Failure
Kidney Failure
Heat-Shock Proteins
Children
Lead sponsor: University of Munich Children's Clinic
Sponsor class: OTHER
Collaborators: name: Ludwig-Maximilians - University of Munich
First posted: 2005-09-30
Enrollment: 120
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients on paediatric intensive care units.

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.

Eligibility 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).

Primary outcomes:
measure: Acute renal failure.
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Augsburg
country: Germany
facility: Klinikum Augsburg, II. Klinik für Kinder und Jugendliche
state: Bavaria
city: Memmingen
country: Germany
facility: Kinderklinik Memmingen
state: Bavaria
city: Munich
country: Germany
facility: Klinikum der Universität München, Kinderklinik und Poliklinik im Dr. von Haunerschen Kinderspital
state: Bavaria
city: Munich
country: Germany
facility: Deutsches Herzzentrum München
state: Bavaria
city: Regensburg
country: Germany
facility: Klinkum der Barmherzigen Brüder St. Hedwig
state: Bavaria
city: Rosenheim
country: Germany
facility: Kinderklinik Rosenheim
state: Bavaria
Study officials:
affiliation: Klinikum der Universität München, Kinderklinik und Poliklinik im Dr. von Haunerschen Kinderspital
name: Karl Reiter, Dr. med.
role: STUDY_CHAIR
affiliation: Klinikum der Universität München, Kinderklinik und Poliklinik im Dr. von Haunerschen Kinderspital
name: Judith Glöckner-Pagel, Dr. med.
role: STUDY_DIRECTOR
affiliation: Klinikum der Universität München, Kinderklinik und Poliklinik im Dr. von Haunerschen Kinderspital
name: Dennis A. Ballwieser, cand. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.