A Phase 4 interventional study of Olimel N12 and Glucose IV in End Stage Renal Disease, Malnutrition and Sarcopenia, sponsored by Erasmus Medical Center. Active, not recruiting at 2 sites in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-12.
Sponsored by Erasmus Medical Center · Phase 4, Interventional, and Treatment
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.
2,085 studies on the registry are indexed under Kidney Failure, Chronic; 260 are open to participants now.
This study's planned enrollment of 166 is above the median of 55 across 1,557 interventional studies indexed under Kidney Failure, Chronic.
Browse Kidney Failure, Chronic studies →Erasmus Medical Center is the lead sponsor of 466 studies on the registry; 179 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Intradialytic parenteral nutrition three times weekly during 16 weeks
Drug: Olimel N12
5% glucose three times weekly during 16 weeks
Drug: Glucose IV
A mixture of glucose, lipids, amino acids.
Glucose 5%
Change in lean tissue mass
Measured by body composition monitor (BCM)
Time frame: 16 weeks
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
Subjective global assessment (SGA)
7-point scale, 7 indicates normal nutritional status, 1 indicates severe protein energy wasting
Time frame: 16 weeks
Change in serum albumin concentration
Time frame: 16 weeks
Appetite
Numeric rating scale (0-10, 10 being best appetite)
Time frame: 16 weeks
Plan to share: Undecided
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Erasmus Medical Center