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The Effect of Intradialytic Parenteral Nutrition on Nutritional Status and Quality of Life in Hemodialysis Patients

NCT ID: NCT04094038

Last Updated: 2024-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

166 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-16

Study Completion Date

2025-09-30

Brief Summary

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Protein-energy wasting (PEW), a hypercatabolic state characterized by loss of muscle mass and fuel reserves, is highly prevalent in hemodialysis patients. Nutritional status and body composition are closely linked to morbidity, mortality and quality of life. Lean tissue mass (LTM) appears to be the best read-out for the association between nutritional status and outcomes. Intradialytic parenteral nutrition (IDPN) is occasionally used with the aim to reduce loss of LTM, but its efficacy has not been established. The goal of this study is to study the effect of IDPN on changes in LTM in hemodialysis patients.

Detailed Description

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Conditions

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End Stage Renal Disease Malnutrition Sarcopenia Hemodialysis Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Intervention

Intradialytic parenteral nutrition three times weekly during 16 weeks

Group Type EXPERIMENTAL

Olimel N12

Intervention Type DRUG

A mixture of glucose, lipids, amino acids.

Placebo

5% glucose three times weekly during 16 weeks

Group Type PLACEBO_COMPARATOR

Glucose IV

Intervention Type DRUG

Glucose 5%

Interventions

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Olimel N12

A mixture of glucose, lipids, amino acids.

Intervention Type DRUG

Glucose IV

Glucose 5%

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Undergoing chronic hemodialysis

Exclusion Criteria

* Life expectancy \< 6 months
* Planned kidney transplant within 4 months
* Severe overhydration leading to respiratory insufficiency
* Parenteral nutrition within four weeks prior to screening
* Severe hepatic insufficiency
* Pregnancy
* Unipolar pacemaker with a very low sensitivity threshold
* Active treatment for infection
* Acute myocardial infarction
* Circulatory shock
* Hypersensitivity for any Olimel N12 ingredient or excipient
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Baxter Healthcare Corporation

INDUSTRY

Sponsor Role collaborator

Erasmus Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Ewout Hoorn

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ewout J Hoorn, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Erasmus Medical Center

Locations

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Erasmus MC

Rotterdam, , Netherlands

Site Status

Franciscus Gasthuis & Vlietland

Rotterdam, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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2018-003899-13

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

NL65803.078.18

Identifier Type: OTHER

Identifier Source: secondary_id

MEC-2018-1452

Identifier Type: OTHER

Identifier Source: secondary_id

IDPN1

Identifier Type: -

Identifier Source: org_study_id