Feasibility of Intradialytic Monitoring During CKRT

April 29, 2026 updated by: Christina Brotman, University of Pennsylvania

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients admitted to one of the Medical ICUs and the Cardiothoracic ICU who have been prescribed CKRT.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Collaborators

Fresenius Medical Care North America

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 17, 2026

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

March 1, 2028

Study Registration Dates

First Submitted

February 10, 2026

First Submitted That Met QC Criteria

February 19, 2026

First Posted (Actual)

February 23, 2026

Study Record Updates

Last Update Posted (Actual)

May 6, 2026

Last Update Submitted That Met QC Criteria

April 29, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 855545

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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