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

Erasmus University

Status and phase: Active, not recruiting; Phase 4

Conditions: Hemodialysis Complication; Malnutrition; End Stage Renal Disease; Sarcopenia

Treatments: Drug: Olimel N12; Drug: Glucose IV

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04094038

NL65803.078.18 (Other Identifier)

IDPN1

2018-003899-13 (EudraCT Number)

MEC-2018-1452 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 166 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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166 participants in 2 patient groups, including a placebo group

Intervention

Experimental group

Description:

Intradialytic parenteral nutrition three times weekly during 16 weeks

Treatment:

Drug: Olimel N12

Placebo

Placebo Comparator group

Description:

5% glucose three times weekly during 16 weeks

Treatment:

Drug: Glucose IV