1. What data in particular will be shared?
   Response - All of the individual participant data collected during the trial, after de-identification.
   


2. What additional supporting information will be shared?
   Response -  Study Protocol
   Response -  Statistical Analysis Plan
   Response - Informed Consent Form
   Response - Clinical Study Report
   Response -  Analytic Code
   
   
3. Who will be able to view these files?
   Response - Anyone
   


4. For what types of analyses will this data be available?
   Response - Any purpose.
   


5. By what mechanism will data be made available?
   Response - Proposals should be directed to [ysrgadwal490@gmail.com].
   


6. For how long will this data be available start date provided 27-05-2028 and end date provided 27-05-2033?
   Response - Beginning 3 months and ending 5 years following article publication.
   


7. Any URL or additional information regarding plan/policy for sharing IPD? 
   Additional Information - NIL

Summary

This dissertation, titled “Epidemiology and Short-term Outcomes of Hospital-Acquired Acute Kidney Injury (AKI) in Critically Ill Adults: A Prospective Cohort Study”, addresses an important knowledge gap in the burden and prognosis of AKI in resource-limited settings. AKI, defined by KDIGO criteria, is a frequent complication in critically ill patients and is strongly associated with morbidity, mortality, and long-term progression to chronic kidney disease. However, there is limited high-quality, prospective data from India and other low- and middle-income countries (LMICs).

The study is designed as a prospective observational cohort enrolling adult patients admitted to the Critical Care Unit (CCU) of a tertiary care hospital. Patients with pre-existing AKI, CKD, renal transplantation, or terminal illness are excluded. Consecutive eligible patients will be followed from admission until 90 days post-discharge. Detailed demographic, clinical, and biochemical data will be collected, including severity scores (APACHE II, SOFA), hemodynamic support, ventilation parameters, and renal biomarkers. AKI will be defined and staged by KDIGO serum creatinine criteria, excluding urine output due to measurement limitations.

The primary objective is to determine the incidence of hospital-acquired AKI (HA-AKI). Secondary objectives include identifying epidemiological risk factors, evaluating outcomes such as length of stay, mechanical ventilation days, and mortality, and specifically assessing Major Adverse Kidney Events (MAKE-30 and MAKE-90)—a composite of death, new renal replacement therapy, or persistent renal dysfunction. Statistical analyses will include regression models for risk factor identification, survival analysis, and relative risk estimation.

The expected outcome is to provide robust epidemiological data on the incidence and short-term prognosis of HA-AKI in critically ill Indian patients. This work will contribute to early recognition, risk stratification, and management strategies, ultimately aiming to reduce AKI-related morbidity and mortality in similar clinical settings.