Post-Filter Hematocrit for Kidney Failure

(CRRTHCT Trial)

Overseen By Benjamin R Griffin, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Gwyndolyn M. Radford

Disqualifiers: ECMO

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines kidney failure patients undergoing continuous renal replacement therapy (CRRT). The goal is to determine if measuring blood thickness after filtering, known as post-filter hematocrit, can predict filter clogging. By collecting blood samples and comparing these measurements, researchers aim to improve treatment effectiveness and reduce complications. This trial is suitable for those currently on CRRT and not using another machine called ECMO. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance future treatment options.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this method is safe for determining hemofilter clotting risk?

Research has shown that the treatment in this study is safe. The procedure involves checking the concentration of red blood cells in the blood, known as hematocrit (Hct). The study aims to determine if a mathematical formula can accurately predict Hct levels after filtering blood during kidney treatment.

The methods for calculating and measuring post-filter hematocrit are not new treatments. They are simply ways to measure blood components and do not involve administering any medication or new therapy, so there is no risk of side effects from the treatments themselves. The process only involves taking blood samples from patients already receiving continuous renal replacement therapy (CRRT), a standard hospital procedure for those with kidney failure.

Since this is a measurement study, the main focus is on ensuring the formula accurately predicts hematocrit levels. It is a low-risk study because it doesn't involve any new or experimental drugs or treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new approach to monitoring kidney failure treatment. Unlike traditional methods that might rely on standard lab tests, this trial examines both calculated and measured post-filter hematocrit levels in patients undergoing continuous renal replacement therapy (CRRT). The goal is to determine which method provides more accurate and timely information on blood concentration levels during treatment. This could lead to better patient outcomes by optimizing fluid removal and reducing complications associated with kidney failure.

Are You a Good Fit for This Trial?

This trial is for patients experiencing filter clotting during continuous renal replacement therapy (CRRT) due to kidney failure or other renal diseases. Participants should be currently undergoing CRRT and able to provide blood samples at various times and flow rates.

Inclusion Criteria

I am 18 or older and have started on continuous renal replacement therapy.

Exclusion Criteria

Patients on ECMO

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day

Study Procedure

Blood samples are collected from the post-filter lines of patients on CRRT at different time points and flow rates to compare measured and calculated post-filter hematocrit values.

1 day

Single visit (in-person)

Follow-up

Participants are monitored for any immediate post-procedure effects and data analysis is conducted to assess agreement between measured and calculated values.

1 day

What Are the Treatments Tested in This Trial?

Interventions

• Calculated Post-Filter Hematocrit
• Measured Post-Filter Hematocrit

Trial Overview

The study aims to validate a formula for calculating post-filter hematocrit (Hct), which may indicate the risk of hemofilter clotting in CRRT. It compares calculated Hct values against actual measurements taken from patients' blood samples during treatment.

How Is the Trial Designed?

Group I: CRRT patients Experimental Treatment 2 Interventions

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

Who Is Running the Clinical Trial?

Gwyndolyn M. Radford

Lead Sponsor

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07293936

Study Details | NCT07293936 | Post-Filter Hematocrit

Filter clotting is a major complication of continuous renal replacement therapy (CRRT), resulting in blood loss, reduced treatment efficacy, and ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8168834/

Impact of pre-transplant renal dysfunction on outcomes ...

Patients with HCT-CI score (excluding the renal component) of ≥5 also had an increased risk of dialysis-dependent renal failure after alloHCT than those with ...

3.

he01.tci-thaijo.org

he01.tci-thaijo.org/index.php/JNST/article/download/263943/179292/1100538

Factors Associated with Hemofilter Clotting in Patients with ...

The primary outcome was hemofilter survival. The secondary outcomes were the associations between FFHct, conventional FF, post-filter ...

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S0085253815497467

Association of hematocrit value with cardiovascular ...

We found higher hematocrit values to be associated with lower hospitalization and mortality (cardiac and all-cause) in incident hemodialysis patients, even in ...

5.

link.springer.com

link.springer.com/article/10.1186/s12882-024-03659-y

A safe and effective protocol for postdilution hemofiltration with ...

This is a monocentric prospective interventional study to evaluate a new RCA protocol for postdilution CVVH. We recruited surgical patients with ...