HemodialysisNCT00190125
The Influences of Malnutrition and Inflammation Complex Syndrome in Hemodialysis Patients
An observational study of Hemodialysis and Malnutrition, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
Trial summary
The purpose of this study is to explore the severity of malnutrition and inflammation in Taiwanese hemodialysis patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodialysis, Malnutrition, Inflammation
- How many people
- 300 participants
- Where
- 1 siteTaiwan
- Study dates
- Start not givento Aug 2007
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who have received hemodialysis therapy for more than three months
Who cannot join
- Having active infection diseases now
- Patients who have a malignancy
- Had cardiovascular events in recent three months
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Far Eastern Memorial Hospital
Pan-Chiao, Taipei Country, 220
Yu-Sen Peng, M.D., 886-89667000 ext. 1514, taan70@yahoo.com.tw
Chih-Kang Chiang, M.D.
About this study
The purpose of this study is to explore the severity of malnutrition and inflammation in Taiwanese hemodialysis patients.
Read the detailed description
Cardiovascular disease is the major of cause of mortality of hemodialysis patients. In addition to diabetes and hypertension, malnutrition and chronic inflammation are well-known to be major risk factors of cardiovascular diseases in normal population. For detecting the malnutrition and chronic inflammation and understanding the exact influences to hemodialysis patients, we conduct this study. We will collect the biochemical parameters, inflammatory markers, lipid parameters, hematologic parameters, and genomic DNA of patients. Then we will prospectively record the hospitalization, cardiovascular events, complications of arteriovenous fistula/graft, and mortality. According to the above results, we try to explore the exact role of malnutrition and inflammation in hemodialysis patients.
- Keywords
- Hemodialysis, Malnutrition, Inflammation
- Medical subject headings
- Malnutrition, Inflammation, Myocardial Ischemia, Stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study completionAug 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HemodialysisStudies 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
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Taiwan University
- Investigators
- Yu-Sen Peng, M.D., Principal investigator, Far Eastern Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00190125
- Sponsor's protocol ID
- FEMH-94008
- Status last verified
- Aug 2005
- First submitted
- 11 Sep 2005
- Last updated
- 9 Feb 2009
- Results posted
- No
Publications
Kalantar-Zadeh K, Ikizler TA, Block G, Avram MM, Kopple JD. Malnutrition-inflammation complex syndrome in dialysis patients: causes and consequences. Am J Kidney Dis. 2003 Nov;42(5):864-81. doi: 10.1016/j.ajkd.2003.07.016.
PubMed 14582032Kalantar-Zadeh K, Kopple JD, Block G, Humphreys MH. Association among SF36 quality of life measures and nutrition, hospitalization, and mortality in hemodialysis. J Am Soc Nephrol. 2001 Dec;12(12):2797-2806. doi: 10.1681/ASN.V12122797.
PubMed 11729250Kalantar-Zadeh K, McAllister CJ, Lehn RS, Lee GH, Nissenson AR, Kopple JD. Effect of malnutrition-inflammation complex syndrome on EPO hyporesponsiveness in maintenance hemodialysis patients. Am J Kidney Dis. 2003 Oct;42(4):761-73. doi: 10.1016/s0272-6386(03)00915-6.
PubMed 14520627Kalantar-Zadeh K, Block G, McAllister CJ, Humphreys MH, Kopple JD. Appetite and inflammation, nutrition, anemia, and clinical outcome in hemodialysis patients. Am J Clin Nutr. 2004 Aug;80(2):299-307. doi: 10.1093/ajcn/80.2.299.
PubMed 15277149Kalantar-Zadeh K, Mehrotra R, Fouque D, Kopple JD. Metabolic acidosis and malnutrition-inflammation complex syndrome in chronic renal failure. Semin Dial. 2004 Nov-Dec;17(6):455-65. doi: 10.1111/j.0894-0959.2004.17606.x.
PubMed 15660576
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influences of Malnutrition and Inflammation Complex Syndrome in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT00190125
- Acronym / sponsor ID
- FEMH-94008
- Keywords
- Hemodialysis, Malnutrition, Inflammation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Collaborators
- National Taiwan University
- Study completion
- Aug 2007 (estimated)
- First posted
- 19 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 this study is to explore the severity of malnutrition and inflammation in Taiwanese hemodialysis patients.
Detailed description
Cardiovascular disease is the major of cause of mortality of hemodialysis patients. In addition to diabetes and hypertension, malnutrition and chronic inflammation are well-known to be major risk factors of cardiovascular diseases in normal population. For detecting the malnutrition and chronic inflammation and understanding the exact influences to hemodialysis patients, we conduct this study. We will collect the biochemical parameters, inflammatory markers, lipid parameters, hematologic parameters, and genomic DNA of patients. Then we will prospectively record the hospitalization, cardiovascular events, complications of arteriovenous fistula/graft, and mortality. According to the above results, we try to explore the exact role of malnutrition and inflammation in hemodialysis patients.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who have received hemodialysis therapy for more than three months
Key exclusion criteria (3 listed)
- Having active infection diseases now
- Patients who have a malignancy
- Had cardiovascular events in recent three months
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 9 Feb 2009.
- Background: PubMed 14582032Kalantar-Zadeh K, Ikizler TA, Block G, Avram MM, Kopple JD. Malnutrition-inflammation complex syndrome in dialysis patients: causes and consequences. Am J Kidney Dis. 2003 Nov;42(5):864-81. doi: 10.1016/j.ajkd.2003.07.016.
- Background: PubMed 11729250Kalantar-Zadeh K, Kopple JD, Block G, Humphreys MH. Association among SF36 quality of life measures and nutrition, hospitalization, and mortality in hemodialysis. J Am Soc Nephrol. 2001 Dec;12(12):2797-2806. doi: 10.1681/ASN.V12122797.
- Background: PubMed 14520627Kalantar-Zadeh K, McAllister CJ, Lehn RS, Lee GH, Nissenson AR, Kopple JD. Effect of malnutrition-inflammation complex syndrome on EPO hyporesponsiveness in maintenance hemodialysis patients. Am J Kidney Dis. 2003 Oct;42(4):761-73. doi: 10.1016/s0272-6386(03)00915-6.
- Background: PubMed 15277149Kalantar-Zadeh K, Block G, McAllister CJ, Humphreys MH, Kopple JD. Appetite and inflammation, nutrition, anemia, and clinical outcome in hemodialysis patients. Am J Clin Nutr. 2004 Aug;80(2):299-307. doi: 10.1093/ajcn/80.2.299.
- Background: PubMed 15660576Kalantar-Zadeh K, Mehrotra R, Fouque D, Kopple JD. Metabolic acidosis and malnutrition-inflammation complex syndrome in chronic renal failure. Semin Dial. 2004 Nov-Dec;17(6):455-65. doi: 10.1111/j.0894-0959.2004.17606.x.
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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.
Yu-Sen Peng, M.D. principal investigator
Far Eastern Memorial 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 Malnutrition, run by Far Eastern Memorial 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 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 9 Feb 2009. 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 Yu-Sen Peng, M.D. (886-2-89667000 ext. 1514, taan70@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 NCT00190125, which also lists 5 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 9 Feb 2009.