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

The effect of IntraDialytic Parenteral Nutrition on nutritional status and quality of life in hemodialysis patients - IDPN-Study

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-003899-13-NL

Enrollment

206

Registered

2018-11-19

Start date

2018-12-20

Completion date

Unknown

Last updated

2019-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malnutrition / Sarcopenia (loss of muscle mass) in hemodialyse patients.

Interventions

Trade Name: Olimel N9 Product Name: Olimel N9 Product Code: RVG 105718 Pharmaceutical Form: Infusion Pharmaceutical form of the placebo:

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: • Life expectancy 20 µmol/l, ASAT + ALAT: > 3 times higher than reference values. • Acute phase of circulatory shock • Acute myocardial infarction • Severe sepsis

Design outcomes

Primary

Measure	Time frame
Main Objective: To study the effect of intradialytic parenteral nutrition (Olimel N9) on lean tissue Mass (LTM) assessed by Body Composition Monitor (BCM) in adult hemodialysis patients; Secondary Objective: • Adipose Tissue Mass (ATM) assessed by Body Composition Monitor (BCM) • Body weight • Dry weight • Phase Angel, assessed by Body Composition Monitor (BCM) • Skeletal Muscle Quality Index (SMQI) assessed by ultrasound • Subjective Global Assessment (SGA), 7 point scale • Functionality assessed by hand grip strenght (HGS) • Appetite, Numeric Rating Scale (NRS) • Food intake assessed by 24-hours recall with global dietary history (calories and protein) • Normalized protein nitrogen appearance (nPNA) • Exercise, assessed by Activ8 and exercise diary • Quality of Life: assessed by questionnaire KDQoL and PANAS • Dialysis adequacy (KT/V) • Serum C-reactive protein (CRP) • Serum albumin • Serum pre-albumin • Serum bicarbonate ;Primary end point(s): Muscle mass (lean tissue mass);Timepoint(s) of evaluation of this end point: Baseline, after 1, 2 and 3 months, and 1 month after infusion	—

Measure

Time frame

Main Objective: To study the effect of intradialytic parenteral nutrition (Olimel N9) on lean tissue Mass (LTM) assessed by Body Composition Monitor (BCM) in adult hemodialysis patients; Secondary Objective: • Adipose Tissue Mass (ATM) assessed by Body Composition Monitor (BCM) • Body weight • Dry weight • Phase Angel, assessed by Body Composition Monitor (BCM) • Skeletal Muscle Quality Index (SMQI) assessed by ultrasound • Subjective Global Assessment (SGA), 7 point scale • Functionality assessed by hand grip strenght (HGS) • Appetite, Numeric Rating Scale (NRS) • Food intake assessed by 24-hours recall with global dietary history (calories and protein) • Normalized protein nitrogen appearance (nPNA) • Exercise, assessed by Activ8 and exercise diary • Quality of Life: assessed by questionnaire KDQoL and PANAS • Dialysis adequacy (KT/V) • Serum C-reactive protein (CRP) • Serum albumin • Serum pre-albumin • Serum bicarbonate ;Primary end point(s): Muscle mass (lean tissue mass);Timepoint(s) of evaluation of this end point: Baseline, after 1, 2 and 3 months, and 1 month after infusion

—

Secondary

Measure	Time frame
Secondary end point(s): Effects on body composition, nutritional status, dialysis characteristics an biochemical parameters. ;Timepoint(s) of evaluation of this end point: Baseline, after 1, 2 and 3 months, and 1 month after infusion	—

Countries

Netherlands

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026