End Stage Renal Disease, Hemodialysis Complication, Malnutrition, Sarcopenia
Conditions
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.
Interventions
DRUGOlimel N12
A mixture of glucose, lipids, amino acids.
DRUGGlucose IV
Glucose 5%
Sponsors
Erasmus Medical Center
Baxter Healthcare Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in lean tissue mass | 16 weeks | Measured by body composition monitor (BCM) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Skeletal muscle quality index (SMQI) | 16 weeks | Assessed by muscle ultrasound |
| Change in adipose tissue mass from baseline | 16 weeks | — |
| Change in hand grip strength from baseline | 16 weeks | 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 | 16 weeks | 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 | 16 weeks | Assessed by Kidney Disease Quality of Life-36 (KDQoL-36) survey (0-100, higher is better) |
| Positive and negative affect | 16 weeks | Assessed by Positive and Negative Affect Schedule (PANAS, 0-100, higher is better) |
| Change in phase angle from baseline | 16 weeks | Assessed by Body Composition Monitor (BCM) |
| Change in body weight from baseline | 16 weeks | — |
| Change in serum prealbumin concentration from baseline | 16 weeks | — |
Countries
Netherlands
Contacts
PRINCIPAL_INVESTIGATOREwout J Hoorn, MD PhD
Erasmus Medical Center
Outcome results
None listed