Acute Kidney Injury Clinical Trial
Official title:
Uplift Modeling to More Narrowly Target Alerts for Acute Kidney Injury
The primary objective of this study is to determine whether the use of uplift (also known as Conditional Average Treatment Effect - CATE) modeling to empirically identify patients expected to benefit the most from AKI alerting and to target AKI alerts to these patients will reduce the rates of AKI progression, dialysis, and mortality.
Status | Recruiting |
Enrollment | 3900 |
Est. completion date | August 2025 |
Est. primary completion date | February 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Adults = 18 years 2. Admitted to a participating hospital 3. Has AKI as defined by creatinine criteria: - 0.3 mg/dl increase in inpatient serum creatinine over 48 hours OR - 50% relative increase in inpatient serum creatinine over 7 days Exclusion Criteria: 1. Dialysis order prior to AKI onset 2. Initial creatinine = 4.0 mg/dl 3. Prior admission in which patient was randomized 4. Admission to hospice service or comfort measures only order 5. ESKD diagnosis code 6. Kidney transplant within six months 7. Opted out of electronic health record research |
Country | Name | City | State |
---|---|---|---|
United States | Yale New Haven Hospital | New Haven | Connecticut |
Lead Sponsor | Collaborator |
---|---|
Yale University | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of patients with progression to a higher stage of AKI OR Dialysis OR Death | Progression of AKI is defined as the increase in KDIGO stage from the time of randomization to the present. For patients who are discharged, we will impute 14-day creatinine using the last observation carried forward method. Dialysis is defined as the receipt of hemodialysis, continuous renal replacement therapy, or peritoneal dialysis. Isolated ultrafiltration treatments will not be included. Mortality will be determined from hospital administrative records. |
Within 14 days from randomization | |
Secondary | 14-day Mortality | Proportion of patients who expire from any cause | Assessed from point of randomization to date of death within 14 days of randomization | |
Secondary | Inpatient mortality | Proportion of patients who expire from any cause | Assessed from point of randomization to date of death from any cause, up to one year post-randomization | |
Secondary | 14-day dialysis | Proportion of patients who receive dialysis (hemodialysis, continuous renal replacement therapy, or peritoneal dialysis) | Assessed from point of randomization to date of first documented dialysis order, within 14 days of randomization | |
Secondary | Inpatient dialysis | Proportion of patients who receive dialysis (hemodialysis, continuous renal replacement therapy, or peritoneal dialysis) | Assess from point of randomization to date of first documented dialysis order during index hospitalization, up to one year post-randomization | |
Secondary | Discharge on dialysis | Assessed as active orders for dialysis at point of discharge from index hospitalization | Assessed at point of discharge from index hospitalization, up to one year post-randomization | |
Secondary | Progression to stage 2 AKI | Proportion of patients with a doubling of serum creatinine from the date of randomization to 14 days post randomization | Assessed from the date of randomization to 14 days post randomization | |
Secondary | Progression to stage 3 AKI | Proportion of patients with a tripling of serum creatinine from the date of randomization to 14 days post randomization | Assessed from the date of randomization to 14 days post randomization | |
Secondary | Duration of AKI | Defined as the time in hours between AKI onset and AKI cessation during index hospitalization | Assessed from the date of randomization to the cessation of AKI during index hospitalization, up to one year | |
Secondary | 30 day readmission rate | Proportion of patients with readmission within 30 days of index hospitalization discharge | Assessed from discharge date of index hospitalization to 30 days post discharge date | |
Secondary | Index hospitalization cost | Total cost of index hospitalization | Assessed from point of randomization to date of discharge from index hospitalization, up to one year | |
Secondary | Chart documentation of AKI | Proportion of patients with chart documentation of AKI as assessed by post-discharge ICD-10 codes | Assessed from date of randomization to date of discharge from index hospitalization, up to one year | |
Secondary | Proportion of AKI "Best Practices" Achieved Per Subject During Index Hospitalization | Contrast administration (de novo order of IV contrast agent within 24 hours of randomization), fluid administration (within 24 hours of randomization), aminoglycoside administration (de novo order within 24 hours of randomization), NSAID administration/cessation (de novo order or cessation of order/absence of de novo order of NSAID within 24 hours of randomization), ACE inhibitor administration/cessation, urinalysis order (with or without microscopy within 24 hours of randomization), documentation of AKI (by ICD-9 and ICD-10 codes during index hospitalization), monitoring of creatinine (at least one serum creatinine measurement within 36 hours of randomization), documentation of urine output (within 24 hours of randomization), renal consult order during index hospitalization. Each metric is binary. Outcome is reported as a composite best practice outcome representing the proportion of best practices achieved per subject. | 24 hours from randomization to discharge, up to one year post randomization |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05538351 -
A Study to Support the Development of the Enhanced Fluid Assessment Tool for Patients With Acute Kidney Injury
|
||
Recruiting |
NCT06027788 -
CTSN Embolic Protection Trial
|
N/A | |
Completed |
NCT03938038 -
Guidance of Ultrasound in Intensive Care to Direct Euvolemia
|
N/A | |
Recruiting |
NCT05805709 -
A Patient-centered Trial of a Process-of-care Intervention in Hospitalized AKI Patients: the COPE-AKI Trial
|
N/A | |
Recruiting |
NCT05318196 -
Molecular Prediction of Development, Progression or Complications of Kidney, Immune or Transplantation-related Diseases
|
||
Recruiting |
NCT05897840 -
Continuous Central Venous Oxygen Saturation Measurement as a Tool to Predict Hemodynamic Instability Related to Renal Replacement Therapy in Critically Ill Patients
|
N/A | |
Recruiting |
NCT04986137 -
Fractional Excretion of Urea for the Differential Diagnosis of Acute Kidney Injury in Cirrhosis
|
||
Terminated |
NCT04293744 -
Acute Kidney Injury After Cardiac Surgery
|
N/A | |
Completed |
NCT04095143 -
Ultrasound Markers of Organ Congestion in Severe Acute Kidney Injury
|
||
Not yet recruiting |
NCT06026592 -
Detection of Plasma DNA of Renal Origin in Kidney Transplant Patients
|
||
Not yet recruiting |
NCT06064305 -
Transcriptional and Proteomic Analysis of Acute Kidney Injury
|
||
Terminated |
NCT03438877 -
Intensive Versus Regular Dosage For PD In AKI.
|
N/A | |
Terminated |
NCT03305549 -
Recovery After Dialysis-Requiring Acute Kidney Injury
|
N/A | |
Completed |
NCT05990660 -
Renal Assist Device (RAD) for Patients With Renal Insufficiency Undergoing Cardiac Surgery
|
N/A | |
Completed |
NCT04062994 -
A Clinical Decision Support Trial to Reduce Intraoperative Hypotension
|
||
Terminated |
NCT02860130 -
Clinical Evaluation of Use of Prismocitrate 18 in Patients Undergoing Acute Continuous Renal Replacement Therapy (CRRT)
|
Phase 3 | |
Completed |
NCT06000098 -
Consol Time and Acute Kidney Injury in Robotic-assisted Prostatectomy
|
||
Not yet recruiting |
NCT05548725 -
Relation Between Acute Kidney Injury and Mineral Bone Disease
|
||
Completed |
NCT02665377 -
Prevention of Akute Kidney Injury, Hearttransplant, ANP
|
Phase 3 | |
Terminated |
NCT03539861 -
Immunomodulatory Biomimetic Device to Treat Myocardial Stunning in End-stage Renal Disease Patients
|
N/A |