HemodialysisNCT00173823
Malnutrition and Inflammation in Dialysis Patients in Taiwan
An observational study of Hemodialysis and Hypercholesterolemia, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
According to the reports of the United States Renal Data System (USRDS), there is a 25% annual mortality rate with nearly 50% of all reported maintenance hemodialysis (HD) patient deaths attributed to atherosclerosis-related complications. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Hemodialysis, Hypercholesterolemia, Malnutrition
- How many people
- 1,500 participants
- Where
- 1 siteTaiwan
- Study dates
- Jun 2004to not given
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- On HD three times a week for more than 3 months (minimizing the confounding effects of residual renal function)
Who cannot join
- Malignancy;
- Obvious infections or inflammatory diseases;
- Preexisting haematological disorders; and,
- Clinically significant bleeding, transfusion, hospitalization, surgery, or renal transplantation
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital and collegues
Taipei
Chih-Kang Chiang, MD, +886-23123456 ext. 3921, ckchiang@ha.mc.ntu.edu.tw
About this study
Official title: Malnutrition and Inflammation in Taiwan: Prospective Outcome Evaluation Method (MIT-POEM) in Dialysis Patients
According to the reports of the United States Renal Data System (USRDS), there is a 25% annual mortality rate with nearly 50% of all reported maintenance hemodialysis (HD) patient deaths attributed to atherosclerosis-related complications. Although traditional risk factors of cardiovascular disease (CVD) are common in end-stage renal disease (ESRD) patients, they alone may be insufficient to account for their high prevalence of CVD. Recent evidence demonstrated high plasma homocysteine levels have been established as a risk factor of chronic inflammation and atherosclerosis in patients with ESRD.
Malnutrition and inflammation was associated with poor quality of life, morbidity and mortality. We, the researchers at National Taiwan University Hospital, hope to establish the best predictive profile of HD patient outcome. Thus, we establish several protocols to complete this work.
- Medical subject headings
- Hypercholesterolemia, Malnutrition, Inflammation, Kidney Failure, Chronic
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 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemodialysisStudies 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
- 1,500 participants
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Chih-Kang Chiang, MD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00173823
- Sponsor's protocol ID
- 9461700840
- Status last verified
- Aug 2005
- First submitted
- 13 Sep 2005
- Last updated
- 13 Mar 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Malnutrition and Inflammation in Taiwan: Prospective Outcome Evaluation Method (MIT-POEM) in Dialysis Patients
- ClinicalTrials.gov ID
- NCT00173823
- Acronym / sponsor ID
- 9461700840
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jun 2004
- 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.
According to the reports of the United States Renal Data System (USRDS), there is a 25% annual mortality rate with nearly 50% of all reported maintenance hemodialysis (HD) patient deaths attributed to atherosclerosis-related complications. Although traditional risk factors of cardiovascular disease (CVD) are common in end-stage renal disease (ESRD) patients, they alone may be insufficient to account for their high prevalence of CVD. Recent evidence demonstrated high plasma homocysteine levels have been established as a risk factor of chronic inflammation and atherosclerosis in patients with ESRD.
Malnutrition and inflammation was associated with poor quality of life, morbidity and mortality. We, the researchers at National Taiwan University Hospital, hope to establish the best predictive profile of HD patient outcome. Thus, we establish several protocols to complete this work.
Study design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- On HD three times a week for more than 3 months (minimizing the confounding effects of residual renal function)
Key exclusion criteria (4 listed)
- Malignancy;
- Obvious infections or inflammatory diseases;
- Preexisting haematological disorders; and,
- Clinically significant bleeding, transfusion, hospitalization, surgery, or renal transplantation
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 13 Mar 2006.
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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.
National Taiwan University Hospital and collegues
Taipei, Taiwan
Chih-Kang Chiang, MD principal investigator
National Taiwan University Hospital
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 Hemodialysis and Hypercholesterolemia, 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 4 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 13 Mar 2006. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
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 13 Mar 2006.