AKI - Acute Kidney Injury, Biomarkers, CKD, Transition to CKD
Conditions
Keywords
AKI, Biomarkers, no recovery
Brief summary
Justification: Studies in recent years have shown that suffering an episode of acute kidney injury (AKI) is an independent risk factor for developing chronic kidney disease (CKD), which is associated with cardiovascular complications, increases medical care costs, and decreases survival. These AKI to ERC transition cases add to the growing number of CKD cases already being seen globally. It is for them that in recent years therapeutic strategies have been sought to reduce or stop this process of transition from AKI to CKD. Objective: To evaluate the efficacy and safety of the use of dapagliflozin plus standard medical treatment (TMS), compared with only TMS for 21 days, in hospitalized patients with a diagnosis of severe AKI (KDIGO 3) in reducing the incidence of CKD to 18 months of follow-up. Design: Randomized, single center, open study. 100 hospitalized patients with a diagnosis of AKI KDIGO 3, without previous CKD, will be randomized to receive 10 mg of dapagliflozin every 24 h for 21 days + TMS or only TMS. During their follow-up, baseline blood and urine samples will be taken and at 3, 6, 12 and 18 months. At 18 months, the development of CKD will be assessed using the KDIGO clinical criteria and with the determination of urinary biomarkers (Serpina A3, HSP72, KIM 1 and NGAL).
Detailed description
It is planned to randomize 100 patients, 50 for each arm of the study. The randomization will be 1: 1 based on an open access computer program. Group 1: Dapagliflozin 10 mg, will be administered orally or by nasogastric tube every 24 h for 21 days. Group 2: Standard of care strategy, patients will receive the usual treatment for their pathology according to the judgment of their treating physician and the Institutional practices, without receiving any of the interventional drugs. Eligibility: Adults (aged \>18 years) with AKI 3 diagnosis for less than 24 h (KDIGO classification, creatinine level or urine output criteria), hospitalized in general admission floor and/or intensive care unit. AKI diagnosis must be compatible with the diagnosis of acute tubular necrosis in a context of ischemic or toxic aggression.
Interventions
DRUGDapagliflozin
dapagliflozin is given for 21 days vs standard of care
Sponsors
Noemi del Toro Cisneros
Olynka Vega Vega
Miguel Ángel Martínez Rojas
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Group 1: Dapagliflozin 10 mg, will be administered orally or by nasogastric tube every 24 h for 21 days. Group 2: Standard of care strategy, patients will receive the usual treatment for their pathology according to the judgment of their treating physician and the Institutional practices, without receiving any of the interventional drugs, but blood and urinary samples will be taken to determine the biomarkers at the times established in the schedule.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Adults (aged \>18 years) with AKI 3 diagnosis for less than 24 h (KDIGO classification, creatinine level or urine output criteria), hospitalized in general admission floor and/or intensive care unit. AKI diagnosis must be compatible with the diagnosis of acute tubular necrosis in a context of ischemic or toxic aggression.
Exclusion criteria
* CKD Stage 3b (KDIGO) or more, renal transplant, urinary tract obstruction, thrombotic microangiopathy, acute glomerulopathy, cardiac arrest without awakening, oncological diagnosis with a life expectancy of less than 5 years, use of norephinephrine \>0.30 mcg/kg/min for 6 h or more, use of two vasopressors, PaO2/FiO2 ratio \<150, Type 1 DM, fasting for more than 48 h, previous inclusion in other study, pregnant or breastfeeding woman.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome will be the mean change in urinary Serpin A3 (uSerpinA3) levels 18 months after randomization of the patients. | 18 months |
Secondary
| Measure | Time frame |
|---|---|
| Urine HSP-72 levels 18 months after randomization of the patients | 18 months |
| Urine NGAL levels 18 months after randomization of the patients | 18 months |
| GFR at 18 months of randomization calcutated with CKD-EPI creatinine-Cystatin C Equation. | 18 months |
| Serum Cystatin C levels 18 months after randomization of the patients | 18 months |
| Serum creatinine levels 18 months after randomization of the patients | 18 months |
| Urine KIM-1 levels 18 months after randomization of the patients | 18 months |
Countries
Mexico
Outcome results
None listed