The effect of nutritional infusion on nutritional status and quality of life in hemodialysis patients

Phase 1

• Conditions: Malnutrition / Sarcopenia (loss of muscle mass) in hemodialyse patients.; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2018-003899-13-NL

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-11-19
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 206

Inclusion Criteria

•Age: = 18 years
•Hemodialysis, 3 times / week, minimum 3,5 hours / session.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 126

Exclusion Criteria

•Life expectancy < 6 months
•Planned kidney transplant within 4 months
•Active treatment for infection
•Pregnancy
•Parenteral nutrition for at least four weeks prior to screening
•Unipolar pacemaker with a very low sensitivity threshold

Regular exclusion criteria for the use of parenteral nutrition in hemodialysis patients:
•Severe overhydration leading to respiratory insufficiency.
•Hypersensitivity for any ingredient or excipients
•Severe hepatic insufficiency, total bilirubin > 20 µmol/l, ASAT + ALAT: > 3 times higher
than reference values.
•Acute phase of circulatory shock
•Acute myocardial infarction
•Severe sepsis

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified