Clinical trial NCT00190125: The Influences of Malnutrition and Inflammation Complex Syndrome in Hemodialysis Patients
Official title: The Influences of Malnutrition and Inflammation Complex Syndrome in Hemodialysis Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hemodialysis
Malnutrition
Inflammation
Myocardial Ischemia
Cerebrovascular Accident
Keywords: Hemodialysis
Malnutrition
Inflammation
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
Collaborators: name: National Taiwan University
First posted: 2005-09-19
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: 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.

Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Pan-Chiao, Taipei country
country: Taiwan
facility: Far Eastern Memorial Hospital
Study officials:
affiliation: Far Eastern Memorial Hospital
name: Yu-Sen Peng, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1016/j.ajkd.2003.07.016.
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):2797-2806. doi: 10.1681/ASN.V12122797.
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. doi: 10.1016/s0272-6386(03)00915-6.
citation: 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. doi: 10.1093/ajcn/80.2.299.
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. doi: 10.1111/j.0894-0959.2004.17606.x.