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

Phase 4

Active, not recruiting

• Conditions: End Stage Renal Disease; Malnutrition; Sarcopenia; Hemodialysis Complication
• Interventions: Drug: Olimel N12; Drug: Glucose IV

• Registration Number: NCT04094038
• Lead Sponsor: Erasmus Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-09-12
• Study Start: 2019-09-16
• Study First Submitted QC: 2019-09-16
• Study First Posted: 2019-09-18
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-24
• Last Update Posted: 2024-12-27
• Primary Completion: 2025-03
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 166

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Olimel N12	Intradialytic parenteral nutrition three times weekly during 16 weeks
Placebo	Glucose IV	5% glucose three times weekly during 16 weeks

Primary Outcome Measures

Name	Time	Method
Change in lean tissue mass	16 weeks	Measured by body composition monitor (BCM)

Secondary Outcome Measures

Name	Time	Method
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)
Change in phase angle from baseline	16 weeks	Assessed by Body Composition Monitor (BCM)
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)
Positive and negative affect	16 weeks	Assessed by Positive and Negative Affect Schedule (PANAS, 0-100, higher is better)
Change in body weight from baseline	16 weeks
Change in serum prealbumin concentration from baseline	16 weeks

Trial Locations

Locations (2)

Erasmus MC; 🇳🇱 Rotterdam, Netherlands

Franciscus Gasthuis & Vlietland; 🇳🇱 Rotterdam, Netherlands