Discontinuing CRRT in Patients with Acute Kidney Injury

NCT04898595 | Completed

• 1 other identifier: 2101226767
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

• 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.

  7 consecutive days post last CRRT performed

Secondary Outcomes (4)

• Major adverse kidney events (MAKE30)

  Up to 30 days

• CRRT duration

  1 to 100 days

• Intermittent hemodialysis after CRRT discontinuation

  Within 7 days post DC CRRT

• Adverse events occurring within 7 days after discontinuation of CRRT

  Within 7 days post DC CRRT

Study Arms (2)

Usual Process of Care

NO INTERVENTION

No intervention

Standardized approach to discontinuation of CRRT

EXPERIMENTAL

Criteria-driven approach

Procedure: Discontinuation of CRRT

Interventions

Discontinuation of CRRT PROCEDURE

Discontinuation of CRRT will be guided by an algorithm based on patient current condition.

Standardized approach to discontinuation of CRRT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• West Virginia University: lead

Study Sites (1)

West Virginia University

Morgantown, West Virginia, 26508, United States

Location

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Khaled Shawwa, MD

  West Virginia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: May 19, 2021
• First Posted: May 24, 2021
• Study Start: June 1, 2021
• Primary Completion: December 12, 2024
• Study Completion: December 12, 2024
• Last Updated: February 27, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)