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

The effect of intradialytic supplementation in chronic hemodialysis patients; a pilot study - Intradialytic creatine suppletion

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON51287

Enrollment

Registered

2022-09-27

Start date

2023-08-03

Completion date

Unknown

Last updated

2024-08-19

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

Conditions

Renal failure

Interventions

Creatine will be added to the dialysis fluid and will thus be continuously administered during the whole hemodialysis session. We will study the effect of four increasing dosages of creatine (3 out

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
The main parameters for the pilot study are the plasma creatine concentration and intra-erythrocytic creatine concentration of both pre- and post-hemodialysis samples. Intra-erythrocytic creatine concentration will be used as a non-invasive proxy for creatine tissue uptake.	—

Secondary

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

Measure

Time frame

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

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)