The Influences of Malnutrition and Inflammation Complex S... | NCT00190125

Studies
The Influences of Malnutrition and Inflammation Complex Syndrome in Hemodialysis Patients

NCT00190125

Sponsor

Far Eastern Memorial Hospital

Status

Unknown status

Last Update Posted

Feb 9, 2009Estimated

Enrollment

300Estimated

Phase

Not provided

Conditions

Hemodialysis
Malnutrition
Inflammation
Myocardial Ischemia
Cerebrovascular Accident

Interventions

Not provided

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2005

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Aug 2007Estimated

First Submitted Date

Sep 11, 2005

First Submission Date that Met QC Criteria

Sep 11, 2005

First Posted Date

Sep 19, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 6, 2009

Last Update Posted Date

Feb 9, 2009Estimated

Name	Class
National Taiwan University	OTHER

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yu-Sen Peng, M.D.	Contact	886-2-89667000	1514	taan70@yahoo.com.tw
Chih-Kang Chiang, M.D.	Contact	886-2-23123456	3923	ckchiang@mail.femh.org.tw

Overall Officials

Name	Affiliation	Role
Yu-Sen Peng, M.D.	Far Eastern Memorial Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Far Eastern Memorial Hospital		Pan-Chiao, Taipei Country		220	Taiwan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
14582032	Background	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.
11729250	Background	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.

ID	Term
D044342	Malnutrition
D007249	Inflammation
D017202	Myocardial Ischemia
D020521	Stroke

ID	Term
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms