Kidney Failure, AcuteHSPNCT00230412
Study of Heat Shock Proteins as Prognostic Factor of Acute Renal Failure in Children (HSP-Study)
An observational study of Kidney Failure, Acute, run by University of Munich Children's Clinic at 6 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Kidney Failure, Acute
- How many people
- 120 participants
- Where
- 6 sitesGermany
- Study dates
- Oct 2005to Dec 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients on paediatric intensive care units.
Who may be able to join
- 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.
Who cannot join
- Existing affection of the kidney.
- Kidney transplantation.
- Missing written consent of the parents or guardian (if applicable).
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Germany6 sites, 6 recruiting
- Recruiting
Klinikum Augsburg, II. Klinik für Kinder und Jugendliche
Augsburg, Bavaria, 86156
Gernot Buheitel, Prof. Dr., +49-821-400-3431, sekretariat@2.kk.augsburg-med.de
Wilfried Schenk, Dr. med., +49-821-400-3431, sekretariat@2.kk.augsburg-med.de
- Recruiting
Kinderklinik Memmingen
Memmingen, Bavaria, 87700
Martin Ries, Prof. Dr., +49-8331-70-2300, info@kinderklinik-memmingen.de
Dennis A Ballwieser, cand. med.
- Recruiting
Klinikum der Universität München, Kinderklinik und Poliklinik im Dr. von Haunerschen Kinderspital
Munich, Bavaria, 80337
Dennis A. Ballwieser, cand. med., +49-89-5160-7813, dennis.ballwieser@med.uni-muenchen.de
Judith Glöckner-Pagel, Dr. med., +49-89-5160-7895, judith.gloeckner@med.uni-muenchen.de
- Not yet recruiting
Deutsches Herzzentrum München
Munich, Bavaria, 80636
Gunter Balling, M. D., +49-89-1218 ext. 3303, balling@dhm.mhn.de
Dennis A Ballwieser, cand. med.
- Recruiting
Klinkum der Barmherzigen Brüder St. Hedwig
Regensburg, Bavaria, 93049
Hugo Segerer, Prof. Dr., +49-941-369-5401, kinderundjugendmedizin@barmherzige-regensburg.de
Peter Schindler, Physician, +49-941-369-5401, kinderundjugendmedizin@barmherzige-regensburg.de
- Recruiting
Kinderklinik Rosenheim
Rosenheim, Bavaria, 83022
Torsten Uhlig, Dr. med., +49-8031-3634-51, kinderklinik@kliro.de
Wolfgang John, Dr. med., +49-8031-3634-51, kinderklinik@kliro.de
About this study
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.
Read the 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.
- Conditions
- Kidney Failure, Acute
- Keywords
- Kidney Failure, Acute, Acute Renal Failure, Kidney Failure, Heat-Shock Proteins, Children
- Medical subject headings
- Acute Kidney Injury, Renal Insufficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute renal failure.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2005 (estimated)
- Study startOct 2005
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Kidney Failure, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Munich Children's Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Ludwig-Maximilians - University of Munich
- Investigators
- Karl Reiter, Dr. med., Study chair, Klinikum der Universität München, Kinderklinik und Poliklinik im Dr. von Haunerschen KinderspitalJudith Glöckner-Pagel, Dr. med., Study director, Klinikum der Universität München, Kinderklinik und Poliklinik im Dr. von Haunerschen KinderspitalDennis A. Ballwieser, cand. med., Principal investigator, Klinikum der Universität München, Kinderklinik und Poliklinik im Dr. von Haunerschen Kinderspital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00230412
- Sponsor's protocol ID
- HSP-233-05
- Other IDs
- Projektnummer 233-05
- Acronym
- HSP
- Status last verified
- Jan 2010
- First submitted
- 28 Sep 2005
- Last updated
- 2 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 15680458Schrier 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.
PubMed 15247356Thadhani 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.
PubMed 8618585Schiffl 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.
PubMed 11821506
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Heat Shock Proteins as Prognostic Factor of Acute Renal Failure in Children (HSP-Study)
- ClinicalTrials.gov ID
- NCT00230412
- Acronym / sponsor ID
- HSP / HSP-233-05
- Conditions
- Kidney Failure, Acute
- Keywords
- Kidney Failure, Acute, Acute Renal Failure, Kidney Failure, Heat-Shock Proteins, Children
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of Munich Children's ClinicUniversity, hospital or other
- Collaborators
- Ludwig-Maximilians - University of Munich
- Study start
- Oct 2005
- Study completion
- Dec 2010 (estimated)
- First posted
- 30 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients on paediatric intensive care units.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Existing affection of the kidney.
- Kidney transplantation.
- Missing written consent of the parents or guardian (if applicable).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Acute renal failure.
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2010.
- Background: PubMed 15680458Lameire 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.
- Background: PubMed 15247356Schrier 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.
- Background: PubMed 8618585Thadhani 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.
- Background: PubMed 11821506Schiffl 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.
- Dr. von Haunersches Kinderspital München/University of Munich Children's ClinicLink provided by the sponsor.
- Universität München/University of MunichLink provided by the sponsor.
- City of Memmingen Children's ClinicLink provided by the sponsor.
- City of Augsburg ClinicLink provided by the sponsor.
- City of Rosenheim ClinicLink provided by the sponsor.
- The Brothers of Mercy's Hospital at RegensburgLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karl Reiter, Dr. med. study chair
Klinikum der Universität München, Kinderklinik und Poliklinik im Dr. von Haunerschen Kinderspital
Judith Glöckner-Pagel, Dr. med. study director
Klinikum der Universität München, Kinderklinik und Poliklinik im Dr. von Haunerschen Kinderspital
Dennis A. Ballwieser, cand. med. principal investigator
Klinikum der Universität München, Kinderklinik und Poliklinik im Dr. von Haunerschen Kinderspital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Failure, Acute, run by University of Munich Children's Clinic at 6 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dennis A. Ballwieser, cand. med. (+49-89-2621-7564, dennis.ballwieser@med.uni-muenchen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute renal failure. (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00230412, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2010.