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

Study Overview
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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.

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

Conditions
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End Stage Renal Disease, Malnutrition, Sarcopenia, Hemodialysis Complication

Intervention / Treatment
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* Drug: Olimel N12
* Drug: Glucose IV


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Intradialytic parenteral nutrition three times weekly during 16 weeks | Drug: Olimel N12<br>* A mixture of glucose, lipids, amino acids.<br>|
| Placebo Comparator: Placebo<br>5% glucose three times weekly during 16 weeks | Drug: Glucose IV<br>* Glucose 5%<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in lean tissue mass | Measured by body composition monitor (BCM) | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skeletal muscle quality index (SMQI) | Assessed by muscle ultrasound | 16 weeks | 
| Change in adipose tissue mass from baseline |  | 16 weeks | 
| Change in hand grip strength from baseline | Measured by hand dynamometer, expressed as percentile of reference (by age and gender) | 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) | 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) | 16 weeks | 
| Positive and negative affect | Assessed by Positive and Negative Affect Schedule (PANAS, 0-100, higher is better) | 16 weeks | 
| Change in phase angle from baseline | Assessed by Body Composition Monitor (BCM) | 16 weeks | 
| Change in body weight from baseline |  | 16 weeks | 
| Change in serum prealbumin concentration from baseline |  | 16 weeks |