PeritonitisNCT00173485
The Study of Infection and Cell Inflammation in Peritoneal Dialysate
An observational study of Peritonitis and Kidney Failure, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
A progressive decline of plasma triggering receptor expressed on myeloid cells-1 (TREM-1) concentration indicates a favorable clinical evolution during the recovery phase of sepsis. The expression of TREM-1 in dialysate of peritoneal dialysis patients was not yet documented. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Peritonitis, Kidney Failure
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- Jun 2005to Jun 2009
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- peritoneal dialysis patients, dialysis period for more than 3 months.
Who cannot join
- age younger than 18 years old, Pregnant or lactating women. (Pre-menopause women, capable of bearing children will undergo pregnancy test)
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
Vincent Wu, MD, 886-2-2356-2000, walt-wu@yahoo.com.tw
About this study
A progressive decline of plasma triggering receptor expressed on myeloid cells-1 (TREM-1) concentration indicates a favorable clinical evolution during the recovery phase of sepsis. The expression of TREM-1 in dialysate of peritoneal dialysis patients was not yet documented. We will collect the dialysate of peritonitis in peritoenal dialysis patients and analyze the time serial change.
Read the detailed description
The triggering receptor expressed on myeloid cells-1 (TREM-1) is a member of the immunoglobulin superfamily, and its expression is upregulated on phagocytic cells in the presence of bacteria or fungi (1). Several experiments by Bouchon and colleagues showed that TREM-1 mediates the acute inflammatory response to microbial products. Human tissues infected with bacteria are infiltrated with neutrophils and macrophages that express high levels of TREM-1. Conversely, TREM-1 is only weakly expressed in samples from patients with noninfectious inflammatory disorders. In addition, TREM-1 is shed from the membrane of activated phagocytes and can be found in a soluble form in body fluids. The presence of a soluble form of TREM-1 in samples of bronchoalveolar lavage fluid from mechanically ventilated patients has been shown to be a good indicator of infectious pneumonia. During sepsis, a progressive decline of plasma sTREM-1 concentration indicates a favorable clinical evolution during the recovery phase of sepsis. In addition, baseline sTREM-1 level may prove useful in predicting outcome of septic patients. We will collect the dialysate of peritonitis in peritoneal dialysis patients and analyze the time serials change.
- Conditions
- Peritonitis, Kidney Failure
- Keywords
- peritonitis, peritoneal dialysis, dialysate
- Medical subject headings
- Peritonitis, Renal Insufficiency
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startJun 2005
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PeritonitisStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Defined population
- Time perspective
- Other
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Kwan-Dun Wu, MD, PhD, Study chair, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00173485
- Sponsor's protocol ID
- 9461700636
- Status last verified
- Jun 2005
- First submitted
- 12 Sep 2005
- Last updated
- 24 Nov 2005
- Results posted
- No
Publications
Bouchon A, Dietrich J, Colonna M. Cutting edge: inflammatory responses can be triggered by TREM-1, a novel receptor expressed on neutrophils and monocytes. J Immunol. 2000 May 15;164(10):4991-5. doi: 10.4049/jimmunol.164.10.4991.
PubMed 10799849Bouchon A, Facchetti F, Weigand MA, Colonna M. TREM-1 amplifies inflammation and is a crucial mediator of septic shock. Nature. 2001 Apr 26;410(6832):1103-7. doi: 10.1038/35074114.
PubMed 11323674Gibot S, Cravoisy A, Levy B, Bene MC, Faure G, Bollaert PE. Soluble triggering receptor expressed on myeloid cells and the diagnosis of pneumonia. N Engl J Med. 2004 Jan 29;350(5):451-8. doi: 10.1056/NEJMoa031544.
PubMed 14749453
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of Infection and Cell Inflammation in Peritoneal Dialysate
- ClinicalTrials.gov ID
- NCT00173485
- Acronym / sponsor ID
- 9461700636
- Conditions
- Peritonitis, Kidney Failure
- Keywords
- peritonitis, peritoneal dialysis, dialysate
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jun 2005
- Study completion
- Jun 2009
- First posted
- 15 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.
A progressive decline of plasma triggering receptor expressed on myeloid cells-1 (TREM-1) concentration indicates a favorable clinical evolution during the recovery phase of sepsis. The expression of TREM-1 in dialysate of peritoneal dialysis patients was not yet documented. We will collect the dialysate of peritonitis in peritoenal dialysis patients and analyze the time serial change.
Detailed description
The triggering receptor expressed on myeloid cells-1 (TREM-1) is a member of the immunoglobulin superfamily, and its expression is upregulated on phagocytic cells in the presence of bacteria or fungi (1). Several experiments by Bouchon and colleagues showed that TREM-1 mediates the acute inflammatory response to microbial products. Human tissues infected with bacteria are infiltrated with neutrophils and macrophages that express high levels of TREM-1. Conversely, TREM-1 is only weakly expressed in samples from patients with noninfectious inflammatory disorders. In addition, TREM-1 is shed from the membrane of activated phagocytes and can be found in a soluble form in body fluids. The presence of a soluble form of TREM-1 in samples of bronchoalveolar lavage fluid from mechanically ventilated patients has been shown to be a good indicator of infectious pneumonia. During sepsis, a progressive decline of plasma sTREM-1 concentration indicates a favorable clinical evolution during the recovery phase of sepsis. In addition, baseline sTREM-1 level may prove useful in predicting outcome of septic patients. We will collect the dialysate of peritonitis in peritoneal dialysis patients and analyze the time serials change.
Study design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- peritoneal dialysis patients, dialysis period for more than 3 months.
Key exclusion criteria (1 listed)
- age younger than 18 years old, Pregnant or lactating women. (Pre-menopause women, capable of bearing children will undergo pregnancy test)
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2005.
- Background: PubMed 10799849Bouchon A, Dietrich J, Colonna M. Cutting edge: inflammatory responses can be triggered by TREM-1, a novel receptor expressed on neutrophils and monocytes. J Immunol. 2000 May 15;164(10):4991-5. doi: 10.4049/jimmunol.164.10.4991.
- Background: PubMed 11323674Bouchon A, Facchetti F, Weigand MA, Colonna M. TREM-1 amplifies inflammation and is a crucial mediator of septic shock. Nature. 2001 Apr 26;410(6832):1103-7. doi: 10.1038/35074114.
- Background: PubMed 14749453Gibot S, Cravoisy A, Levy B, Bene MC, Faure G, Bollaert PE. Soluble triggering receptor expressed on myeloid cells and the diagnosis of pneumonia. N Engl J Med. 2004 Jan 29;350(5):451-8. doi: 10.1056/NEJMoa031544.
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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.
Kwan-Dun Wu, MD, PhD study chair
National Taiwan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peritonitis and Kidney Failure, run by National Taiwan University Hospital at 1 site in Taiwan.
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 1 inclusion and 1 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 24 Nov 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. 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 Vin-cent Wu, MD (886-2-2356-2000, walt-wu@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00173485, which also lists 3 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 24 Nov 2005.