Discontinuing CRRT in Patients with Acute Kidney Injury (DC-CRRT)

February 24, 2025 updated by: Khaled Shawwa, West Virginia University

Discontinuation of Continuous Renal Replacement Therapy in Patients with Acute Kidney Injury: a Pilot Quasi-experimental Study (DC-CRRT)

In this study, investigators are going to test whether a standardize approach to discontinuation of Continuous Renal Replacement Therapy (CRRT) using a set of criteria improves outcomes. These criteria are based on the best available evidence. In a systematic review, aside from urine output, there was no one factor that predicted successful weaning of RRT in patients with AKI. Urine output prior to discontinuation of RRT was the most commonly described and robust predictor. The pooled analysis found a sensitivity of 66.2% and specificity of 73.6% for urine output to predict successful RRT discontinuation. Patients with AKI on CRRT recruited during the first half of the study will be controls (usual process of care). After accrual, patients recruited for the second half will receive the intervention where discontinuation of CRRT will be guided by a set of criteria based on the patient's hemodynamic status and other factors.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

To the investigator's knowledge, no study has evaluated the impact of a standardized approach to de-escalation of Continuous Renal Replacement Therapy (CRRT) in patients with AKI. Exposure to more frequent and higher intensity RRT has been associated with delayed renal recovery. There is scant evidence in the literature on benefit or harm associated with a standardized approach to de-escalation of CRRT on the outcomes of successful weaning of CRRT, impact on CRRT duration, renal recovery, safety and adverse events. Thus, this generates a clinical equipoise. Therefore, this study should help guide nephrologists and intensivists on the appropriate management of CRRT in patients with AKI.

This is a prospective quasi-experimental (before-after) study of patients with acute kidney injury requiring continuous renal replacement therapy in the intensive care unit. It will be based on Good Clinical Practice Standards and performed under IRB supervision. This will be a quasi-experimental study design due to the nature of the intervention and the processes of care leading to making a clinical decision. Patients with AKI on CRRT will be prospectively recruited. Patients recruited during the first half of the study will be in the control arm where usual process of care will not be altered. After accrual, patients recruited for the second half will receive the intervention where discontinuation of CRRT will be guided by a set of criteria based on the patient's hemodynamic status and other factors. A decision tree form would be filled by one of the team members each day. This will increase adherence to the protocol and allow us to track reasons for not discontinuing CRRT when it is suggested to do so.

Patients will be approached within 24-36 hours of starting CRRT. Patients will be eligible for trial entry after the decision is made to pursue CRRT. Patients with provided informed consent will be accrued in the study.

The hypothesis is that the intervention arm will lead to earlier discontinuation of CRRT. This may translate to less treatment-associated adverse events, namely intradialytic hypotension, and potentially improve the chance of renal recovery. Investigators will collect data on persistent kidney dysfunction at 30 days after AKI as defined by persistent need for RRT or doubling of baseline creatinine.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
67

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • West Virginia
      • Morgantown, West Virginia, United States, 26508
        • West Virginia University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

  • Diagnosis of acute kidney injury
  • Being started on continuous renal replacement therapy

Exclusion criteria:

  • Diagnosis of chronic kidney disease stage 5 or end-stage renal disease
  • Having received a kidney transplant
  • Moribund patients (who are expected to die within 1 day of CRRT initiation)
  • Presence of an intoxication requiring extracorporeal removal
  • RRT within the previous 1 month
  • Rapidly progressive glomerulonephritis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Usual Process of Care
No intervention
Experimental: Standardized approach to discontinuation of CRRT
Criteria-driven approach
Procedure: Discontinuation of CRRT
Discontinuation of CRRT will be guided by an algorithm based on patient current condition.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Successful discontinuation of Continuous Renal Replacement Therapy
Time Frame: 7 consecutive days post last CRRT performed
Successful discontinuation of CRRT is defined by being free from any form of renal replacement therapy for at least 7 consecutive days. We will measure the difference in the proportion of participants who achieve successful discontinuation of CRRT between the two groups.
7 consecutive days post last CRRT performed

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Major adverse kidney events (MAKE30)
Time Frame: Up to 30 days
The composite outcome of death, continued need of dialysis, and persistent kidney dysfunction (defined as doubling of baseline creatinine) at day 30 after starting CRRT.
Up to 30 days
CRRT duration
Time Frame: 1 to 100 days
Absolute number of days the subject received CRRT prior to first discontinuation.
1 to 100 days
Intermittent hemodialysis after CRRT discontinuation
Time Frame: Within 7 days post DC CRRT
Number of subjects that require intermittent hemodialysis after discontinuation of CRRT
Within 7 days post DC CRRT
Adverse events occurring within 7 days after discontinuation of CRRT
Time Frame: Within 7 days post DC CRRT

Any adverse events, from the below list, that occur within 7 days after discontinuation of CRRT

  • Hyperkalemia with potassium of >6.1 mmol/L
  • Severe metabolic acidosis (defined as pH ≤7·20, PaCO2 ≤45 mm Hg, and bicarbonate concentration ≤20 mmol/L)
  • Complications of hypervolemia
  • Catheter-related blood stream infections
Within 7 days post DC CRRT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
West Virginia University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Khaled Shawwa, MD, West Virginia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 12, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 12, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 19, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 19, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 24, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 24, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2101226767

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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