Intradialytic monitoring of mitochondrial oxygen tension and bioimpedance.

Intradialytic monitoring of mitochondrial oxygen tension and bioimpedance. - WITNESS

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON57354

Enrollment

Registered

2024-09-16

Start date

2025-07-05

Completion date

Unknown

Last updated

2026-03-16

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

Conditions

Chronic kidney disease Chronic kidney disease

Interventions

Phtonics Healthcare: Cellular Oxygen METabolism (COMET) monitor.&nbsp

AIKON Health: Health sensor platform 4.0 (manufactured by Analog devices).&nbsp

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: For dialysis patientsAge 18 years or higher. On hemodialysis treatment for at least three months. For pre-dialysis patientsAge 18 yers or higher Chronic kidney disease stage 4 or 5Not treated with dialysis 

Exclusion criteria

Exclusion criteria: Major limb amputations. Presence of cardiac implants. Skin conditions aggravated by sunlight or increased sensitivity to light. Hypersensitivity to 5-aminolevulinc acid. Pregnanty or breastfeeding. Insufficient comprehensibility of the Dutch or English language. Porphyria.

Design outcomes

Primary

Measure	Time frame
The primary objectives of this study are to is to describe the effects of the HD treatment with and without ultrafiltration on the change in mitoPO2 and mitoVO2.	—

Secondary

Measure	Time frame
The secondary objectives of this study are to - Compare pre-dialysis mitoPO2 and mitoVO2 baseline values to the values obtained in previous studies with the COMET. - Describe the relation between changes in skin mitoPO2 and mitoVO2 and intradialytic continuous thoracic bioimpedance. - Describe the relation between changes in skin mitoPO2 and mitoVO2 and intradialytic continuous calf bioimpedance. - Describe the relation between changes in skin mitoPO2 and mitoVO2 and the change in extracellular resistance ratio measured at the calf - To evaluate the change in mitoPO2 and bioimpedance prior to and after intradialytic hypotensive symptoms - To perform validation of the TBW algorithm from the bioimpedance results by use of the Body Composition Monitor (BCM) Secondary study parameters are - Symptoms of intradialytic hypotension - Interventions during HD treatment, e.g. positioning in Trendelenburg or terminating ultrafiltration. - Total body water from local thoracic bioimpedance measurements - Total body water from local calf bioimpedance measurements	—

Measure

Time frame

The secondary objectives of this study are to - Compare pre-dialysis mitoPO2 and mitoVO2 baseline values to the values obtained in previous studies with the COMET. - Describe the relation between changes in skin mitoPO2 and mitoVO2 and intradialytic continuous thoracic bioimpedance. - Describe the relation between changes in skin mitoPO2 and mitoVO2 and intradialytic continuous calf bioimpedance. - Describe the relation between changes in skin mitoPO2 and mitoVO2 and the change in extracellular resistance ratio measured at the calf - To evaluate the change in mitoPO2 and bioimpedance prior to and after intradialytic hypotensive symptoms - To perform validation of the TBW algorithm from the bioimpedance results by use of the Body Composition Monitor (BCM) Secondary study parameters are - Symptoms of intradialytic hypotension - Interventions during HD treatment, e.g. positioning in Trendelenburg or terminating ultrafiltration. - Total body water from local thoracic bioimpedance measurements - Total body water from local calf bioimpedance measurements

—

Countries

Netherlands

Contacts

Public ContactS.H. Josemans

Leids Universitair Medisch Centrum

s.h.josemans@lumc.nl+31715298163

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Mar 20, 2026