Clinical trial NCT00314834: Effect of Intradialytic Parenteral Nutrition on Morbidity and Mortality of Malnourished Hemodialysis Patients
Official title: Effect of Intradialytic Parenteral Nutrition on Morbidity and Mortality of Malnourished Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Hemodialysis
Malnutrition
Keywords: hemodialysis
intradialytic parenteral nutrition
oral supplementation
survival
hospitalization
serum albumin
prealbumin
transthyretin
Lead sponsor: EZUS-LYON 1
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
name: Societe Francaise de Dialyse
name: Societe Francophone de Nutrition Enterale et Parenterale
First posted: 2006-04-17
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Maximum age (years): 82
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: IDPN is widely used in HD patients without clue of its effectiveness. Study objectives: to evaluate IDPN effects on mortality (main objective), hospitalization rates, nutritional status, dialysis efficacy, Karnofsky score

Detailed description: IDPN is widely used in HD patients without clue of its effectiveness. Study objectives: to evaluate IDPN effects on mortality (main objective), hospitalization rates, nutritional status, dialysis efficacy, Karnofsky score.

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.

Eligibility criteria: Inclusion Criteria:

* age between 18 and 82 years
* 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:

* weekly dialysis time \< 12 h
* 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

Primary outcomes:
measure: mortality
Secondary outcomes:
measure: hospitalization rate, Karnofsky score, BMI, serum albumin and prealbumin
Other outcomes:
Locations:
Study officials:
name: Noel JM Cano, MD-PhD
role: STUDY_DIRECTOR
References:
citation: 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.