NCT00314834

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
204

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2001

Longer than P75 for phase_4

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2001

Completed
3.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

April 14, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 17, 2006

Completed
Last Updated

April 17, 2006

Status Verified

March 1, 2005

First QC Date

April 14, 2006

Last Update Submit

April 14, 2006

Conditions

HemodialysisMalnutrition

Keywords

hemodialysisintradialytic parenteral nutritionoral supplementationsurvivalhospitalizationserum albuminprealbumintransthyretin

Outcome Measures

Primary Outcomes (1)

  • mortality

Secondary Outcomes (1)

  • hospitalization rate, Karnofsky score, BMI, serum albumin and prealbumin

Interventions

Intradialytic parenteral nutritionDRUG

Eligibility Criteria

Age18 Years - 82 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 17656473DERIVED

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Noel JM Cano, MD-PhD

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 14, 2006

First Posted

April 17, 2006

Study Start

January 1, 2001

Study Completion

December 1, 2004

Last Updated

April 17, 2006

Record last verified: 2005-03