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Clinical Trial Details

Trial ID: L1474
Source ID: NCT04094038
Associated Drug: Olimel N12
Title: The Effect of Intradialytic Parenteral Nutrition on Nutritional Status and Quality of Life in Hemodialysis Patients
Acronym:
Status: ACTIVE_NOT_RECRUITING
Study Results: NO
Results:
Conditions: End Stage Renal Disease|Malnutrition|Sarcopenia|Hemodialysis Complication
Interventions: DRUG: Olimel N12|DRUG: Glucose IV
Outcome Measures: Primary: Change in lean tissue mass, Measured by body composition monitor (BCM), 16 weeks | Secondary: 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 | Other: Subjective global assessment (SGA), 7-point scale, 7 indicates normal nutritional status, 1 indicates severe protein energy wasting, 16 weeks|Change in serum albumin concentration, 16 weeks|Appetite, Numeric rating scale (0-10, 10 being best appetite), 16 weeks
Sponsor/Collaborators: Sponsor: Erasmus Medical Center | Collaborators: Baxter Healthcare Corporation
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 166
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2019-09-16
Completion Date: 2025-09
Results First Posted:
Last Update Posted: 2024-12-27
Locations: Erasmus MC, Rotterdam, Netherlands|Franciscus Gasthuis & Vlietland, Rotterdam, Netherlands
URL: https://clinicaltrials.gov/show/NCT04094038