Effect of Intradialytic Parenteral Nutrition on Morbidity and Mortality of Malnourished Hemodialysis Patients
NCT ID: NCT00314834
Last Updated: 2006-04-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE4
204 participants
INTERVENTIONAL
2001-01-31
2004-12-31
Brief Summary
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Detailed Description
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Patient eligibility: adult patients ≤ 82 y with HD vintage \> 6 mo. and 2 of the following malnutrition criteria: BMI ≤ 20 kg/m2, BW loss/6 mo. ≥ 10%, serum albumin ≤ 35 g/L, prealbumin ≤ 300 mg/L.
Recruitment: patients in 38 HD units from January 2001 to December 2002 Study protocol. Patients are randomized into 2 groups: IDPN group, given IDPN during one year, and control group. For ethical reasons, the 2 groups are given oral supplementation during the same period.
Follow-up: two years after start of nutritional therapy. Study end: December 31, 2004. Final results will be available in early 2005.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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Intradialytic parenteral nutrition
Eligibility Criteria
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Inclusion Criteria
* hemodialysis vintage more than 6 months
* two of the following markers of malnutrition:
* body mass index (BMI) \<= 20 kg/m2
* body weight loss within 6 months \>= 10 percent
* serum albumin \<= 35 g/L
* prealbumin \<= 300 mg/L
Exclusion Criteria
* urea Kt/V index \< 1.2
* serum albumin \> 38 g/L
* prealbumin \> 330 mg/L
* hypertriglyceridemia \> 2.5 mmol/L
* associated comorbidities compromising the one-year survival
* treatment by oral, enteral or parenteral feeding during the last 3 months
* hospitalization at time of randomization
18 Years
82 Years
ALL
No
Sponsors
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Institut National de la Santé Et de la Recherche Médicale, France
OTHER_GOV
Societe Francaise de Dialyse
UNKNOWN
Societe Francophone de Nutrition Enterale et Parenterale
OTHER
EZUS-LYON 1
OTHER
Principal Investigators
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Noel JM Cano, MD-PhD
Role: STUDY_DIRECTOR
References
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Cano NJ, Fouque D, Roth H, Aparicio M, Azar R, Canaud B, Chauveau P, Combe C, Laville M, Leverve XM; French Study Group for Nutrition in Dialysis. Intradialytic parenteral nutrition does not improve survival in malnourished hemodialysis patients: a 2-year multicenter, prospective, randomized study. J Am Soc Nephrol. 2007 Sep;18(9):2583-91. doi: 10.1681/ASN.2007020184. Epub 2007 Jul 26.
Other Identifiers
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EZUS-A1244
Identifier Type: -
Identifier Source: org_study_id