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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT00190125
Other study ID # FEMH-94008
Secondary ID
Status Not yet recruiting
Phase N/A
First received September 11, 2005
Last updated February 6, 2009
Est. completion date August 2007

Study information

Verified date August 2005
Source Far Eastern Memorial Hospital
Contact Yu-Sen Peng, M.D.
Phone 886-2-89667000
Email taan70@yahoo.com.tw
Is FDA regulated No
Health authority Taiwan: Department of Health
Study type Observational

Clinical Trial Summary

The purpose of this study is to explore the severity of malnutrition and inflammation in Taiwanese hemodialysis patients.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 300
Est. completion date August 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients who have received hemodialysis therapy for more than three months

Exclusion Criteria:

- Having active infection diseases now

- Patients who have a malignancy

- Had cardiovascular events in recent three months

Study Design

Time Perspective: Prospective


Locations

Country Name City State
Taiwan Far Eastern Memorial Hospital Pan-Chiao, Taipei country

Sponsors (2)

Lead Sponsor Collaborator
Far Eastern Memorial Hospital National Taiwan University

Country where clinical trial is conducted

Taiwan, 

References & Publications (5)

Kalantar-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. — View Citation

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. Review. — View Citation

Kalantar-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):2797-806. — View Citation

Kalantar-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. — View Citation

Kalantar-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. Review. — View Citation

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