Clinical trial NCT04094038: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: End Stage Renal Disease
Malnutrition
Sarcopenia
Hemodialysis Complication
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
Collaborators: name: Baxter Healthcare Corporation
First posted: 2019-09-18
Enrollment: 166
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in lean tissue mass
timeFrame: 16 weeks
Secondary outcomes:
measure: Skeletal muscle quality index (SMQI)
timeFrame: 16 weeks
measure: Change in adipose tissue mass from baseline
timeFrame: 16 weeks
measure: Change in hand grip strength from baseline
timeFrame: 16 weeks
measure: Change in kidney disease quality of life (KDQoL-36) energy/fatigue scale from baseline
timeFrame: 16 weeks
measure: Change in kidney disease quality of life (KDQoL-36, overall health rating) from baseline
timeFrame: 16 weeks
measure: Positive and negative affect
timeFrame: 16 weeks
measure: Change in phase angle from baseline
timeFrame: 16 weeks
measure: Change in body weight from baseline
timeFrame: 16 weeks
measure: Change in serum prealbumin concentration from baseline
timeFrame: 16 weeks
Other outcomes:
measure: Subjective global assessment (SGA)
timeFrame: 16 weeks
measure: Change in serum albumin concentration
timeFrame: 16 weeks
measure: Appetite
timeFrame: 16 weeks
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus MC
city: Rotterdam
country: Netherlands
facility: Franciscus Gasthuis & Vlietland
Study officials:
affiliation: Erasmus Medical Center
name: Ewout J Hoorn, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: