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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04458571
Other study ID # 18-0405
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 1, 2020
Est. completion date December 21, 2022

Study information

Verified date February 2023
Source University of Colorado, Denver
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 112
Est. completion date December 21, 2022
Est. primary completion date December 21, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States University of Colorado Hospital Aurora Colorado

Sponsors (1)

Lead Sponsor Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Steady State Metabolites 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 3 years
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