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

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ClinicalTrials.gov Identifier: NCT00314834
Recruitment Status : Terminated
First Posted : April 17, 2006
Last Update Posted : April 17, 2006
Sponsor:
Collaborators:
Institut National de la Santé Et de la Recherche Médicale, France
Societe Francaise de Dialyse
Societe Francophone de Nutrition Enterale et Parenterale
Information provided by:
EZUS-LYON 1

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

Condition or disease Intervention/treatment Phase
Hemodialysis Malnutrition Drug: Intradialytic parenteral nutrition Phase 4

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.


Study Type : Interventional  (Clinical Trial)
Enrollment : 204 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Intradialytic Parenteral Nutrition on Morbidity and Mortality of Malnourished Hemodialysis Patients
Study Start Date : January 2001
Study Completion Date : December 2004

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. mortality

Secondary Outcome Measures :
  1. hospitalization rate, Karnofsky score, BMI, serum albumin and prealbumin


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 82 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00314834


Sponsors and Collaborators
EZUS-LYON 1
Institut National de la Santé Et de la Recherche Médicale, France
Societe Francaise de Dialyse
Societe Francophone de Nutrition Enterale et Parenterale
Investigators
Study Director: Noel JM Cano, MD-PhD

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00314834     History of Changes
Other Study ID Numbers: EZUS-A1244
First Posted: April 17, 2006    Key Record Dates
Last Update Posted: April 17, 2006
Last Verified: March 2005

Keywords provided by EZUS-LYON 1:
hemodialysis
intradialytic parenteral nutrition
oral supplementation
survival
hospitalization
serum albumin
prealbumin
transthyretin

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders