Post-Filter Hematocrit

NCT07293936 | Recruiting

• 1 other identifier: 202412294
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Continuous Renal Replacement Therapy; Renal Failure; Hemofilter Clotting

Keywords

crrt; continuous renal replacement therapy; hemofilter clotting; post-filter hematocrit; filtration fraction

Outcome Measures

Primary Outcomes (1)

• Agreement between measured and calculated post-filter hematocrit values.

  Use Bland-Altman analysis to assess agreement and quantify bias and limits of agreement. Calculate correlation coefficients (Pearson or Spearman) to evaluate the strength of association.

  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 Outcomes (2)

• Analyze the impact of CRRT settings on discrepancies between measured and calculated Filtration Fraction

  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

  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.

Study Arms (1)

CRRT patients

OTHER

All participants will receive the same "intervention" of both measuring and calculating post-filter hematocrit.

Other: Calculated Post-Filter Hematocrit; Other: Measured Post-Filter Hematocrit

Interventions

Calculated Post-Filter Hematocrit OTHER

using the formula: HCTpost=HCTpre/(FF(HCTpre-1)+1)

CRRT patients

Measured Post-Filter Hematocrit OTHER

Measured from blood sample taken from CRRT machine

CRRT patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• patients on ECMO

Sponsors & Collaborators

• Gwyndolyn M. Radford: lead

Study Sites (1)

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Gwyndolyn M Radford, MD

CONTACT

7858179620; gradford@uiowa.edu

Benjamin R Griffin, MD

CONTACT

5073631404; benjamin-griffin@uiowa.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: All participants will undergo the same "intervention" of both using their blood samples to measure post-filter hematocrit and using their other lab values and CRRT settings to calculate post-filter hematocrit.

Study Record Dates

• First Submitted: March 4, 2025
• First Posted: December 19, 2025
• Study Start: March 15, 2025
• Primary Completion: February 1, 2026
• Study Completion: March 15, 2026
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)