search
Back to results

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

Primary Purpose

Acute Kidney Injury

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Discontinuation of CRRT
Sponsored by
West Virginia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Kidney Injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • West Virginia UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual Process of Care

Standardized approach to discontinuation of CRRT

Arm Description

No intervention

Criteria-driven approach

Outcomes

Primary Outcome Measures

Successful discontinuation of Continuous Renal Replacement Therapy
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.

Secondary Outcome Measures

Major adverse kidney events (MAKE30)
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.
CRRT duration
Absolute number of days the subject received CRRT prior to first discontinuation.
Intermittent hemodialysis after CRRT discontinuation
Number of subjects that require intermittent hemodialysis after discontinuation of CRRT
Adverse events occurring within 7 days after discontinuation of 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

Full Information

First Posted
May 19, 2021
Last Updated
April 27, 2023
Sponsor
West Virginia University
search

1. Study Identification

Unique Protocol Identification Number
NCT04898595
Brief Title
Discontinuing CRRT in Patients With Acute Kidney Injury
Acronym
DC-CRRT
Official Title
Discontinuation of Continuous Renal Replacement Therapy in Patients With Acute Kidney Injury: A Pilot Quasi-experimental Study (DC-CRRT)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
West Virginia University

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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. 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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
142 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Usual Process of Care
Arm Type
No Intervention
Arm Description
No intervention
Arm Title
Standardized approach to discontinuation of CRRT
Arm Type
Experimental
Arm Description
Criteria-driven approach
Intervention Type
Procedure
Intervention Name(s)
Discontinuation of CRRT
Intervention Description
Discontinuation of CRRT will be guided by an algorithm based on patient current condition.
Primary Outcome Measure Information:
Title
Successful discontinuation of Continuous Renal Replacement Therapy
Description
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.
Time Frame
7 consecutive days post last CRRT performed
Secondary Outcome Measure Information:
Title
Major adverse kidney events (MAKE30)
Description
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.
Time Frame
Up to 30 days
Title
CRRT duration
Description
Absolute number of days the subject received CRRT prior to first discontinuation.
Time Frame
1 to 100 days
Title
Intermittent hemodialysis after CRRT discontinuation
Description
Number of subjects that require intermittent hemodialysis after discontinuation of CRRT
Time Frame
Within 7 days post DC CRRT
Title
Adverse events occurring within 7 days after discontinuation of CRRT
Description
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
Time Frame
Within 7 days post DC CRRT

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Khaled Shawwa, MD
Phone
3042932551
Email
khaled.shawwa@hsc.wvu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Khaled Shawwa, MD
Organizational Affiliation
West Virginia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
West Virginia University
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26508
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Khaled Shawwa, MD
Phone
304-293-2551
Email
khaled.shawwa@hsc.wvu.edu

12. IPD Sharing Statement

Learn more about this trial

Discontinuing CRRT in Patients With Acute Kidney Injury

We'll reach out to this number within 24 hrs