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

Phase 4Active Not RecruitingNCT04094038

Erasmus Medical Center166 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

166

Conditions

End Stage Renal Disease Malnutrition Sarcopenia Hemodialysis Complication

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change in lean tissue mass

Measured by body composition monitor (BCM)

Time frame: 16 weeks

Secondary Outcomes

Skeletal muscle quality index (SMQI)

Assessed by muscle ultrasound

Time frame: 16 weeks

Change in adipose tissue mass from baseline

Time frame: 16 weeks

Change in hand grip strength from baseline

Measured by hand dynamometer, expressed as percentile of reference (by age and gender)

Time frame: 16 weeks

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)

Time frame: 16 weeks

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)

Time frame: 16 weeks

Positive and negative affect

Assessed by Positive and Negative Affect Schedule (PANAS, 0-100, higher is better)

Time frame: 16 weeks

Change in phase angle from baseline

Assessed by Body Composition Monitor (BCM)

Time frame: 16 weeks

Change in body weight from baseline

Time frame: 16 weeks

Change in serum prealbumin concentration from baseline

Time frame: 16 weeks

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

Overview

Conditions

Interventions

Eligibility

Locations (2)

Outcomes

Primary Outcomes

Secondary Outcomes