Acute Kidney Injury, AKI, Critically Ill Acute Kidney Injury, Dialysis, Renal Replacement Therapy, Renal Replacement Therapy for Acute Kidney Injury in ICU
Conditions
Keywords
AKI, ICU, RRT, Latin America, acute kidney injury, renal replacement therapy, intensive care unit, dialysis
Brief summary
This is an international, multicenter, observational study aimed at investigating acute kidney injury requiring renal replacement therapy (AKI-RRT) in Latin American countries. The main questions this study aims to answer are: * What is the epidemiology, outcomes, and processes of care for patients with AKI-RRT in Latin America? * How do outcomes differ across different countries in Latin America? * What factors (demographics, clinical, socioeconomic) influence outcomes in patients with AKI-RRT in Latin America? The main aims of this study are to: * Establish a comprehensive database containing clinical, laboratory, treatment, process, and outcome data of patients with AKI-RRT in Latin America * Describe current epidemiology of AKI-RRT in Latin America * Compare processes of care and outcomes across different countries in Latin America * Provide data resources to facilitate and promote clinical research in AKI-RRT
Interventions
None listed
Sponsors
University of Alabama at Birmingham
Vantive Health LLC
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patient (≥18) admitted to the ICU * First ICU admission during current hospitalization * Diagnosis of acute kidney injury stage 3 according to KDIGO guidelines * RRT initiated no earlier than 3 days before or no later than 7 days after ICU admission
Exclusion criteria
* Transfer from outside hospital with ongoing RRT * RRT exposure of less than 2 days (if CRRT or PD was provided) or less than 2 HD/SLED sessions * Kidney failure (ESRD) patients on maintenance dialysis * Kidney transplant recipients * Previous or new diagnosis of glomerulonephritis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| In-hospital mortality | From enrollment to hospital discharge or 90 days (whichever occurs first) | The variable is coded as 1 = deceased and 0 = alive by the time of hospital discharge |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ICU mortality | From enrollment to ICU discharge or 90 days (whichever occurs first) | The variable is coded as 1 = deceased and 0 = alive by the time of ICU discharge |
| 90-day follow-up mortality | From enrollment to 90-days post-ICU admission follow-up | The variable is coded as 1 = deceased and 0 = alive by the time of 90-day follow-up |
| Length of stay in the ICU | From ICU admission to death or ICU discharge (truncated at 90 days) | Length of stay will be calculated as the total number of full days between admission and discharge from the ICU. A calendar day will be counted toward the total only if the duration of stay on that day is two hours or longer. |
| Length of stay in the hospital | From hospital admission to death or hospital discharge (truncated at 90 days) | Length of stay will be calculated as the total number of full days between admission and discharge from the hospital. A calendar day will be counted toward the total only if the duration of stay on that day is two hours or longer. |
| Renal function recovery at hospital discharge | From enrollment to hospital discharge or 90 days (whichever occurs first) | Recovery will be defined as improvement in kidney function based on serum creatinine value at hospital discharge compared with baseline serum creatinine. Baseline serum creatinine will be defined as either of the following (in order of priority) 1) Average of 3 closest outpatient values 7-365 days before index hospitalization; 2) Lowest value in the inpatient setting 7-365 days before index hospitalization; 3) Lowest value in the first 30 days during index hospitalization (not during or within 48h after RRT discontinuation). Patients who have serum creatinine \<0.3 mg/dL higher than baseline at hospital discharge will be considered to have recovered renal function. |
| Renal function recovery at follow-up | From enrollment to 90-days post-ICU admission follow-up | Recovery will be defined as improvement in kidney function based of serum creatinine value at follow-up compared with baseline serum creatinine. Baseline serum creatinine will be defined as either of the following (in order to priority) 1) Average of 3 closest outpatient values 7-365 days before index hospitalization; 2) Lowest value in the inpatient setting 7-365 days before index hospitalization; 3) Lowest value in the first 30 days during index hospitalization (not during or within 48h after RRT discontinuation). Patients who have serum creatinine \<0.3 mg/dl higher than baseline at follow-up will be considered to have recovered renal function. |
| RRT dependence at hospital discharge | From RRT initiation to hospital discharge or 90 days (whichever occurs first) | Patients will be classified as RRT-dependent if they continue to require any form of RRT at discharge. Patients who no longer require RRT will be classified as RRT-independent. |
| RRT dependence at follow-up | From RRT initiation (day 0) to 90-days post-ICU admission follow-up | Patients will be classified as RRT-dependent if they continue to require any form of RRT at follow-up assessment. Patients who no longer require RRT will be considered RRT-independent. |
| Anticoagulation-related complications associated with RRT | RRT initiation (day 0) to RRT day 6 or RRT termination (whichever occurs first) | These include complications attributable to different types of anticoagulation (systemic unfractionated heparin, systemic low molecular weight heparin, regional citrate anticoagulation, other) used during RRT. Events include hemorrhage, heparin-induced thrombocytopenia (where relevant), citrate excess (where relevant), and citrate deficit (where relevant). |
| Infectious complications associated with RRT | RRT initiation (day 0) to RRT day 6 or RRT termination (whichever occurs first) | These include infections associated with RRT. Events include catheter-related bloodstream infections, catheter insertion-site infections, and secondary peritonitis. |
| RRT-related procedural complications | RRT initiation (day 0) to RRT day 6 or RRT termination (whichever occurs first) | Procedural or mechanical complications occurring during RRT will be identified from medical records and bedside documentation. These include catheter malfunction (e.g., kinking, disconnection, malposition, migration, catheter tip adherence to vessel wall), circuit interruptions, circuit replacements, RRT downtime (where relevant). |
Countries
Bolivia, Brazil, Chile, Colombia, Dominican Republic, Ecuador, Guatemala, Mexico, Peru
Contacts
CONTACTJavier A Neyra, MD, MSCS
CONTACTPatricia J Busta Flores
PRINCIPAL_INVESTIGATORJavier A Neyra, MD, MSCS
University of Alabama at Birmingham
Outcome results
None listed