Feasibility of Intradialytic Monitoring During CKRT

Feasibility of Intradialytic Hematocrit and Oxygen Saturation Monitoring During Continuous Kidney Replacement Therapy

Status

Enrolling by invitation

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07428395

Enrollment

Registered

2026-02-23

Start date

2026-03-17

Completion date

2028-03-01

Last updated

2026-05-06

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

Conditions

Acute Kidney Injury, Dialysis, End Stage Chronic Renal Failure

Brief summary

This is a pilot observational cohort study to understand whether advanced monitoring techniques can be applied during continuous kidney replacement therapy (CKRT), which is the most common form of dialytic therapy provided in critically ill patients.

Detailed description

The CritLine-IV® monitor is a non-invasive device which integrates into the dialysis circuitry to continuous provide hematocrit and oxygen saturation values during dialysis. This monitoring has been used both in clinical and research settings with good accuracy over 4 hours of hemodialysis and has been used to guide real-time decisions on fluid management during intermittent hemodialysis. Given its non-invasive application, continuous measurements, and ease of integration into the dialysis circuitry, this technology has great potential for use in the critical care setting, where changes in clinical status and acuity of illness often require frequent reassessment and adjustment of dialysis settings. However, the reliability of Critline-IV® measurements over longer periods of time is unknown. In this study, we intend to determine the accuracy over time of Critline-IV® monitoring during CKRT, establish whether it impacts CKRT performance (primarily dialysis filter patency), and explore potential signal changes during various interventions commonly performed in the intensive care unit.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Patients who have been admitted to the Medical ICU or Cardiothoracic ICU at the Hospital of the University of Pennsylvania (HUP). 2. Patients who have been prescribed continuous venovenous hemodialysis (CVVHD) or Continuous Veno-Venous Hemofiltration (CVVH), the predominant modalities of continuous kidney replacement therapy (CKRT) at HUP. 3. Patients who have central venous catheters placed in either the left or right internal jugular veins.

Exclusion criteria

1. Patients who are prescribed other forms of CKRT, namely continuous venovenous hemofiltration (CVVH), slow continuous ultrafiltration (SCUF), or prolonged intermittent kidney replacement therapy (PIKRT). 2. Patients who have femoral vein dialysis catheters placed. 3. Patients who cannot provide consent or have a legal proxy to provide consent.

Design outcomes

Primary

Measure	Time frame
Accuracy (% deviation) of hematocrit measured by CLM (Hct CLM) and hematocrit as measured by complete blood count (Hct CBC).	48-hour dialysis treatment

Secondary

Measure	Time frame
Accuracy (% deviation) oxygen saturated measured by CLM (SpO2 CLM) and oxygen saturation as measured by complete blood count (SpO2 VBG)	48-hour dialysis treatment
Time of patency of the NxStage-CritLine cartridge/filter system	48-hour dialysis treatment

Countries

United States

Outcome results