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

Primary Purpose

End Stage Renal Disease, Malnutrition, Sarcopenia

Status
Recruiting
Phase
Phase 4
Locations
Netherlands
Study Type
Interventional
Intervention
Olimel N12
Glucose IV
Sponsored by
Erasmus Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End Stage Renal Disease

Eligibility Criteria

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

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

Sites / Locations

  • Erasmus MCRecruiting
  • Franciscus Gasthuis & VlietlandRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intervention

Placebo

Arm Description

Intradialytic parenteral nutrition three times weekly during 16 weeks

5% glucose three times weekly during 16 weeks

Outcomes

Primary Outcome Measures

Change in lean tissue mass
Measured by body composition monitor (BCM)

Secondary Outcome Measures

Skeletal muscle quality index (SMQI)
Assessed by muscle ultrasound
Change in adipose tissue mass from baseline
Change in hand grip strength from baseline
Measured by hand dynamometer, expressed as percentile of reference (by age and gender)
Change in kidney disease quality of life (KDQoL-36) energy/fatigue scale from baseline
Assessed by Kidney Disease Quality of Life-36 (KDQoL-36) survey (energy/fatigue scale, 0-100, higher is better)
Change in kidney disease quality of life (KDQoL-36, overall health rating) from baseline
Assessed by Kidney Disease Quality of Life-36 (KDQoL-36) survey (0-100, higher is better)
Positive and negative affect
Assessed by Positive and Negative Affect Schedule (PANAS, 0-100, higher is better)
Change in phase angle from baseline
Assessed by Body Composition Monitor (BCM)
Change in body weight from baseline
Change in serum prealbumin concentration from baseline

Full Information

First Posted
September 12, 2019
Last Updated
July 26, 2022
Sponsor
Erasmus Medical Center
Collaborators
Baxter Healthcare Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT04094038
Brief Title
The Effect of Intradialytic Parenteral Nutrition on Nutritional Status and Quality of Life in Hemodialysis Patients
Official Title
The Effect of Intradialytic Parenteral Nutrition on Nutritional Status and Quality of Life in Hemodialysis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 16, 2019 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Erasmus Medical Center
Collaborators
Baxter Healthcare Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease, Malnutrition, Sarcopenia, Hemodialysis Complication

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
166 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Intradialytic parenteral nutrition three times weekly during 16 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
5% glucose three times weekly during 16 weeks
Intervention Type
Drug
Intervention Name(s)
Olimel N12
Intervention Description
A mixture of glucose, lipids, amino acids.
Intervention Type
Drug
Intervention Name(s)
Glucose IV
Intervention Description
Glucose 5%
Primary Outcome Measure Information:
Title
Change in lean tissue mass
Description
Measured by body composition monitor (BCM)
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Skeletal muscle quality index (SMQI)
Description
Assessed by muscle ultrasound
Time Frame
16 weeks
Title
Change in adipose tissue mass from baseline
Time Frame
16 weeks
Title
Change in hand grip strength from baseline
Description
Measured by hand dynamometer, expressed as percentile of reference (by age and gender)
Time Frame
16 weeks
Title
Change in kidney disease quality of life (KDQoL-36) energy/fatigue scale from baseline
Description
Assessed by Kidney Disease Quality of Life-36 (KDQoL-36) survey (energy/fatigue scale, 0-100, higher is better)
Time Frame
16 weeks
Title
Change in kidney disease quality of life (KDQoL-36, overall health rating) from baseline
Description
Assessed by Kidney Disease Quality of Life-36 (KDQoL-36) survey (0-100, higher is better)
Time Frame
16 weeks
Title
Positive and negative affect
Description
Assessed by Positive and Negative Affect Schedule (PANAS, 0-100, higher is better)
Time Frame
16 weeks
Title
Change in phase angle from baseline
Description
Assessed by Body Composition Monitor (BCM)
Time Frame
16 weeks
Title
Change in body weight from baseline
Time Frame
16 weeks
Title
Change in serum prealbumin concentration from baseline
Time Frame
16 weeks
Other Pre-specified Outcome Measures:
Title
Subjective global assessment (SGA)
Description
7-point scale, 7 indicates normal nutritional status, 1 indicates severe protein energy wasting
Time Frame
16 weeks
Title
Change in serum albumin concentration
Time Frame
16 weeks
Title
Appetite
Description
Numeric rating scale (0-10, 10 being best appetite)
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Severs, MD
Phone
+31107040704
Email
d.severs@erasmusmc.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ewout J Hoorn, MD PhD
Organizational Affiliation
Erasmus Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Erasmus MC
City
Rotterdam
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ewout J Hoorn
Phone
+31107040704
First Name & Middle Initial & Last Name & Degree
David Severs, MD
First Name & Middle Initial & Last Name & Degree
Wesley Visser, RD
Facility Name
Franciscus Gasthuis & Vlietland
City
Rotterdam
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martine Verhoeven, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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