AzTrials
AzTrials

AKINCT04458571

Effect of CRRT Duration on Solute Removal

An observational study of AKI and Sepsis, run by University of Colorado, Denver at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
AKI, Sepsis
How many people
112 participants
Where
1 siteUnited States
Study dates
1 Oct 2020to 21 Dec 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Adult patients admitted to University of Colorado Hospital and being initiated on CRRT.

Who may be able to join

  • All adult patients being initiated on CRRT at University of Colorado Hospital (UCH) will be considered for enrollment.

Who cannot join

  • Vulnerable populations such as children, pregnant women, and prisoners will be excluded.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Colorado Hospital

    Aurora, Colorado, 80045

Other trials in United States

About this study

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.

Read the 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.

Conditions
AKI, Sepsis
Medical subject headings
Sepsis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jul 2020
  2. Study start1 Oct 2020
  3. Primary completion21 Dec 2022
  4. Study completion21 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
112 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04458571
Sponsor's protocol ID
18-0405
Status last verified
Feb 2023
First submitted
1 Jul 2020
Last updated
14 Feb 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of AKI and Sepsis, run by University of Colorado, Denver at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Steady State Metabolites (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2023.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in