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Recruiting NCT07293936

Post-Filter Hematocrit

No phase Interventional Continuous Renal Replacement Therapy Renal Failure Hemofilter Clotting

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
The protocol lists: Calculated Post-Filter Hematocrit, Measured Post-Filter Hematocrit.
Who it may be relevant to
Registry conditions: Continuous Renal Replacement Therapy, Renal Failure, Hemofilter Clotting. 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

Validation of a Post-Filter Hematocrit Calculation Formula: A Comparative Analysis With Measured Post-Filter Hematocrit Values

Overview

Filter clotting is a major complication of continuous renal replacement therapy (CRRT), resulting in blood loss, reduced treatment efficacy, and increased cost. One modifiable factor associated with filter clotting is filtration fraction (FF), or the proportion of plasma water being removed from the blood over the course of the filter. In convention, a cutoff of FF\<20-30% has been used to prevent hemofilter clotting, but no evidence correlating FF with hemofilter clotting has been documented. Some experts have proposed that post-filter hematocrit (Hct) could be a more direct marker for determining hemofilter clotting risk, but evidence supporting clinical utility of this marker is lacking. HCTpost=HCTpre/(FF(HCTpre-1)+1) In our proposed validation study, we hope to determine whether our formula for post-filter Hct provides accurate results when compared to measured values. The information obtained from this study will potentially justify the use of utilizing the formula in future studies. The procedure of this study is collecting blood samples from the post-filter lines of patients on CRRT at different time points and different flow rates. This will be considered the "measured post-filter hematocrit" which will then be compared to the calculated formula above, using the other values obtained from daily labs (for pre-filter hematocrit) and CRRT machine settings.

Detailed description

This investigational study is listed as "other" because it is a validation study comparing two measurement methods-comparing a calculated versus a machine-measured post-filter hematocrit- and is typically classified as a cross-sectional investigational study in the context of diagnostic or method comparison research.

Interventions

  • Other Calculated Post-Filter Hematocrit
    using the formula: HCTpost=HCTpre/(FF(HCTpre-1)+1)
  • Other Measured Post-Filter Hematocrit
    Measured from blood sample taken from CRRT machine

Primary outcome measures

  • Agreement between measured and calculated post-filter hematocrit values. [Time frame: Participation begins at consent and includes a single study procedure in which four post-filter blood samples are collected over ~40 minutes. Participation ends after the final draw. Generally, no longer than 1 day.]
Secondary outcome measures (2)
  • Analyze the impact of CRRT settings on discrepancies between measured and calculated Filtration Fraction [Time frame: Participation begins at consent and includes a single study procedure in which four post-filter blood samples are collected over ~40 minutes. Participation ends after the final draw. Generally, no longer than one day.]
  • Subgroup analysis based on patient-specific factors [Time frame: Participation begins at consent and includes a single study procedure in which four post-filter blood samples are collected over ~40 minutes. Participation ends after the final draw.]

Eligibility criteria

Inclusion criteria

  • patients initiated on CRRT age equal than or greater to 18 years of age

Exclusion criteria

  • patients on ECMO

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

United States · 1 center
  • University of Iowa Hospitals and Clinics — Iowa City

Identifiers

NCT: NCT07293936 · 202412294

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗