Effect of CRRT Duration on Solute Removal

Sponsor
University of Colorado, Denver (Other)
Overall Status
Recruiting
CT.gov ID
NCT04458571
Collaborator
(none)
112
1
32.9
3.4

Study Details

Study Description

Brief Summary

The only FDA approved treatment for acute kidney injury(AKI) for patients is Dialysis-also known as renal replacement therapy(RRT). Continuous RRT(CRRT) is the preferred method in the ICU. Patients receiving CRRT with AKI will be recruited to the study where blood and effluent will be collect prior to CRRT initiation and Day 1,2,and 3 following. Metabolites will be assessed to determine solute removal, and also to identify the time at which solute removal has reached steady state. This will help determine the best duration of CRRT.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Acute kidney injury (AKI) occurs in 30-50% of hospitalized patients admitted to the intensive care unit (ICU). Dialysis - also known as renal replacement therapy (RRT) - is the only FDA approved treatment for AKI and continuous RRT (CRRT) is generally the preferred method of RRT in the ICU. The in-hospital mortality of patients with AKI requiring dialysis in the ICU is over 50% which is much greater than other serious illnesses.Unfortunately, the quality of care delivered to patients with AKI receiving CRRT is poor due to practice variability and lack of quality indicators to assess CRRT performance. Since one of the fundamental purposes of CRRT is to remove the build-up of metabolites that accumulate during AKI, accurate methods to assess solute clearance would be especially valuable. Indeed, development of methods to assess solute clearance during CRRT has been identified as a research priority. Although changes in plasma creatinine has been suggested as a potential quality indicator of solute removal during CRRT, no study has assessed how reductions of plasma creatinine over time compare to the reductions of other plasma metabolites. Thus, the duration of CRRT necessary to achieve adequate solute removal is unknown - in fact, there is not yet even an agreed-upon working definition of what adequate solute removal during CRRT should be. The investigators propose to conduct a prospective, single center study of 112 CRRT patients to determine the effect of CRRT duration on solute removal in order to identify the time at which solute removal has reached steady state. To assess solute removal, 102 metabolites will be determined in the plasma and effluent via untargeted ultra high pressure liquid chromatography coupled to mass spectrometry (UHPLC-MS). Metabolites will be assessed on plasma collected immediately prior to CRRT initiation, and on plasma and effluent collected on days 1, 2, and 3 post-CRRT initiation. Steady state is defined as the time point at which a plasma metabolite is not significantly reduced during CRRT - as assessed over a 24 hour time period. Based on preliminary data, the investigators hypothesize that >90% of metabolites will reach steady state by day 2 of CRRT, and that >95% of metabolites will reach steady state by day 3 of CRRT.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    112 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Effect of CRRT Duration on Solute Removal
    Actual Study Start Date :
    Oct 1, 2020
    Anticipated Primary Completion Date :
    Jun 30, 2023
    Anticipated Study Completion Date :
    Jun 30, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Steady State Metabolites [3 years]

      The primary outcome of interest is the binary identification of steady state for each metabolite. Approximately 100 metabolites will be measured including amino acids, phosphorus, creatinine, and BUN

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • All adult patients being initiated on CRRT at University of Colorado Hospital (UCH) will be considered for enrollment.
    Exclusion Criteria:
    • Vulnerable populations such as children, pregnant women, and prisoners will be excluded.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Colorado Hospital Aurora Colorado United States 80045

    Sponsors and Collaborators

    • University of Colorado, Denver

    Investigators

    • Principal Investigator: Sarah Faubel, University of Colorado - Anschutz Medical Campus

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Colorado, Denver
    ClinicalTrials.gov Identifier:
    NCT04458571
    Other Study ID Numbers:
    • 18-0405
    First Posted:
    Jul 7, 2020
    Last Update Posted:
    Nov 2, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Nov 2, 2021