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TerminatedNCT00314834Updated Apr 17, 2006

Effect of Intradialytic Parenteral Nutrition on Morbidity and Mortality of Malnourished Hemodialysis Patients

A Phase 4 interventional study of Intradialytic parenteral nutrition in Hemodialysis and Malnutrition, sponsored by EZUS-LYON 1. Terminated. Open to participants aged 18 Years to 82 Years. Per ClinicalTrials.gov, last updated 2006-04-17.

Sponsored by EZUS-LYON 1 · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
204
Allocation
Randomized
Ages
18 Years to 82 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Hemodialysis
  • Malnutrition

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Keywords

  • hemodialysis
  • intradialytic parenteral nutrition
  • oral supplementation
  • survival
  • hospitalization
  • serum albumin
  • prealbumin
  • transthyretin
03

In context

Malnutrition

1,587 studies on the registry are indexed under Malnutrition; 237 are open to participants now.

This study's enrollment of 204 is above the median of 90 across 1,134 interventional studies indexed under Malnutrition.

Browse Malnutrition studies →

Lead sponsor

EZUS-LYON 1 is the lead sponsor of 5 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 82 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
204 participants

Interventions

  • DrugIntradialytic parenteral nutrition
06

What researchers measure

Primary outcomes

  1. mortality

Secondary outcomes

  1. hospitalization rate, Karnofsky score, BMI, serum albumin and prealbumin

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 17656473 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 17, 2006, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00314834
Lead sponsor
EZUS-LYON 1
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France, Societe Francaise de Dialyse, Societe Francophone de Nutrition Enterale et Parenterale
First posted
Apr 17, 2006
Start date
Jan 2001
Completion
Dec 2004
Last update
Apr 17, 2006

Study contacts

Noel JM Cano, MD-PhD
study director
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Mar 2005. You cannot join it, but the record below documents what was studied.

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