Acute Kidney Injury Clinical Trial
— DC-CRRTOfficial title:
Discontinuation of Continuous Renal Replacement Therapy in Patients With Acute Kidney Injury: A Pilot Quasi-experimental Study (DC-CRRT)
NCT number | NCT04898595 |
Other study ID # | 2101226767 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | June 1, 2021 |
Est. completion date | May 2024 |
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.
Status | Recruiting |
Enrollment | 142 |
Est. completion date | May 2024 |
Est. primary completion date | May 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | West Virginia University | Morgantown | West Virginia |
Lead Sponsor | Collaborator |
---|---|
West Virginia University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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. | Up to 30 days | |
Secondary | CRRT duration | Absolute number of days the subject received CRRT prior to first discontinuation. | 1 to 100 days | |
Secondary | Intermittent hemodialysis after CRRT discontinuation | Number of subjects that require intermittent hemodialysis after discontinuation of CRRT | Within 7 days post DC CRRT | |
Secondary | 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 =7ยท20, PaCO2 =45 mm Hg, and bicarbonate concentration =20 mmol/L) Complications of hypervolemia Catheter-related blood stream infections |
Within 7 days post DC CRRT |
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