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

Sarcopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04094038
• Other study ID #: IDPN1
• Secondary ID: 2018-003899-13NL
• Status: Recruiting
• Phase: Phase 4
• Start date: September 16, 2019
• Est. completion date: September 2023

Study information

• Verified date: July 2022
• Source: Erasmus Medical Center
• Contact: David Severs, MD
• Phone: +31107040704
• Email: d.severs[@]erasmusmc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 166
• Est. completion date: September 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• End Stage Renal Disease
• Hemodialysis Complication
• Kidney Failure, Chronic
• Malnutrition
• Sarcopenia

Intervention

Drug:
• Olimel N12
A mixture of glucose, lipids, amino acids.
• Glucose IV
Glucose 5%

Locations

Country	Name	City	State
Netherlands	Erasmus MC	Rotterdam
Netherlands	Franciscus Gasthuis & Vlietland	Rotterdam

Sponsors (2)

Lead Sponsor	Collaborator
Erasmus Medical Center	Baxter Healthcare Corporation

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Subjective global assessment (SGA)	7-point scale, 7 indicates normal nutritional status, 1 indicates severe protein energy wasting	16 weeks
Other	Change in serum albumin concentration		16 weeks
Other	Appetite	Numeric rating scale (0-10, 10 being best appetite)	16 weeks
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
Secondary	Change in adipose tissue mass from baseline		16 weeks
Secondary	Change in hand grip strength from baseline	Measured by hand dynamometer, expressed as percentile of reference (by age and gender)	16 weeks
Secondary	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
Secondary	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
Secondary	Positive and negative affect	Assessed by Positive and Negative Affect Schedule (PANAS, 0-100, higher is better)	16 weeks
Secondary	Change in phase angle from baseline	Assessed by Body Composition Monitor (BCM)	16 weeks
Secondary	Change in body weight from baseline		16 weeks
Secondary	Change in serum prealbumin concentration from baseline		16 weeks