Feasibility of Intradialytic Monitoring During CKRT
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Acute Kidney Injury, End Stage Chronic Renal Failure, Dialysis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Feasibility of Intradialytic Hematocrit and Oxygen Saturation Monitoring During Continuous Kidney Replacement Therapy
Overview
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.
Primary outcome measures
- 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]
Secondary outcome measures (2)
- 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]
- Time of patency of the NxStage-CritLine cartridge/filter system [Time frame: 48-hour dialysis treatment]
Eligibility criteria
Inclusion criteria
- Patients who have been admitted to the Medical ICU or Cardiothoracic ICU at the Hospital of the University of Pennsylvania (HUP).
- 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.
- Patients who have central venous catheters placed in either the left or right internal jugular veins.
Exclusion criteria
- Patients who are prescribed other forms of CKRT, namely continuous venovenous hemofiltration (CVVH), slow continuous ultrafiltration (SCUF), or prolonged intermittent kidney replacement therapy (PIKRT).
- Patients who have femoral vein dialysis catheters placed.
- Patients who cannot provide consent or have a legal proxy to provide consent.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- University of Pennsylvania — Philadelphia
Identifiers
NCT: NCT07428395 · 855545