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

Primary Purpose

Hemodialysis, Malnutrition

Status
Terminated
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Intradialytic parenteral nutrition
Sponsored by
EZUS-LYON 1
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemodialysis focused on measuring hemodialysis, intradialytic parenteral nutrition, oral supplementation, survival, hospitalization, serum albumin, prealbumin, transthyretin

Eligibility Criteria

18 Years - 82 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    mortality

    Secondary Outcome Measures

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

    Full Information

    First Posted
    April 14, 2006
    Last Updated
    April 14, 2006
    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
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00314834
    Brief Title
    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

    2. Study Status

    Record Verification Date
    March 2005
    Overall Recruitment Status
    Terminated
    Study Start Date
    January 2001 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    December 2004 (undefined)

    3. Sponsor/Collaborators

    Name of the 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

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hemodialysis, Malnutrition
    Keywords
    hemodialysis, intradialytic parenteral nutrition, oral supplementation, survival, hospitalization, serum albumin, prealbumin, transthyretin

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    204 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Intradialytic parenteral nutrition
    Primary Outcome Measure Information:
    Title
    mortality
    Secondary Outcome Measure Information:
    Title
    hospitalization rate, Karnofsky score, BMI, serum albumin and prealbumin

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    82 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Noel JM Cano, MD-PhD
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    17656473
    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.
    Results Reference
    derived

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

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