The effect of intradialytic supplementation in chronic hemodialysis patients; a pilot study

Phase 2

Recruiting

Conditions: Renal failure
Hemodialysis
10038430

Registration Number: NL-OMON51287

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 16

Inclusion Criteria

- Age >=18 years.
- Hemodialysis treatment in the University Medical Centrer MCG or Dialysis
Center Groningen.
- Dialysis vintage >=2 months.
- Conventional hemodialysis, thrice weekly treatment with 3 to 5 hours per
dialysis session.
- Hemoglobin at previous routine monthly assessment greater than or equal to
6.5 mmol/l;
- Signed informed consent.

Exclusion Criteria

- Pregnancy.
- Presence of clinical signs of infection.
- Confirmed diagnosis of malignancies.
- Incapacity of the Dutch language.
- Inability to complete questionnaires.
- Short life expectancy.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main parameters for the pilot study are the plasma creatine concentration<br /><br>and intra-erythrocytic creatine concentration of both pre- and<br /><br>post-hemodialysis samples. Intra-erythrocytic creatine concentration will be<br /><br>used as a non-invasive proxy for creatine tissue uptake. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study parameters are hand grip strength as a measure of muscle<br /><br>strength, the combined interdialytic urinary and intradialytic dialysate<br /><br>excretion of creatinine as a measure of muscle mass [1], and bioelectrical<br /><br>impedance analysis (BIA) as a measure of body composition and nutritional<br /><br>status.<br /><br><br /><br>Other study parameters are N-terminal pro-brain natriuretic peptide (NT-proBNP)<br /><br>as a cardiac function marker, high sensitivity troponin T (hs-TNT) as a cardiac<br /><br>ischaemia marker, C-reactive protein as an inflammation marker, self-reported<br /><br>physical health using the EQ-6D, SF36, and the DSI, fatigue using the CIS and<br /><br>cognitive functions using the CFQ. </p><br>