Effect of Intradialytic Parenteral Nutrition on Morbidity... | NCT00314834

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

NCT00314834

Sponsor

EZUS-LYON 1

Status

Terminated

Last Update Posted

Apr 17, 2006Estimated

Enrollment

204

Phase

Phase 4

Conditions

Hemodialysis
Malnutrition

Interventions

Intradialytic parenteral nutrition

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2005

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2001

Primary Completion Date

Not provided

Completion Date

Dec 2004

First Submitted Date

Apr 14, 2006

First Submission Date that Met QC Criteria

Apr 14, 2006

First Posted Date

Apr 17, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 14, 2006

Last Update Posted Date

Apr 17, 2006Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

EZUS-LYON 1OTHER

Collaborators

Name	Class
Institut National de la Santé Et de la Recherche Médicale, France	OTHER_GOV
Societe Francaise de Dialyse	UNKNOWN
Societe Francophone de Nutrition Enterale et Parenterale	OTHER

Description Module

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

204

Name	Type	Description	Arm Group Labels	Other Names
Intradialytic parenteral nutrition	Drug

Measure	Description	Time Frame
mortality

Measure	Description	Time Frame
hospitalization rate, Karnofsky score, BMI, serum albumin and prealbumin

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

82 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Noel JM Cano, MD-PhD		Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17656473	Derived	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.

ID	Term
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases