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CTRI Number  CTRI/2025/03/081780 [Registered on: 06/03/2025] Trial Registered Prospectively
Last Modified On: 27/02/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   "Acute kidney Injury and its long term consequences in hospitalised patient" 
Scientific Title of Study   A Prospective Evaluation of long-term outcomes and survival after Acute Kidney Injury- the AKI-LOS study 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shayoli Sarkar 
Designation  PhD Scholar 
Affiliation   
Address  Department of Nephrology Kasturba Medical College, Manipal

Udupi
KARNATAKA
576104
India 
Phone  7337298748  
Fax    
Email  shayoli.kmcmpl2024@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Indu Ramachandra Rao 
Designation  Associate Professor 
Affiliation  Kasturba Medical College, Manipal 
Address  Department of Nephrology, Kasturba Medical College, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9592896393  
Fax    
Email  indu.rao@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Shayoli Sarkar 
Designation  PhD Scholar 
Affiliation  Kasturba Medical College, Manipal 
Address  Department of Nephrology Kasturba Medical College, Manipal

Udupi
KARNATAKA
576104
India 
Phone  7337298748  
Fax    
Email  shayoli.kmcmpl2024@learner.manipal.edu  
 
Source of Monetary or Material Support  
Kasturba Medical College, Manipal,Manipal Academy of Higher Education, Manipal, Karnataka, India, 576104 
 
Primary Sponsor  
Name  Nil 
Address  Nil 
Type of Sponsor  Other [Nil] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shayoli Sarkar  Kasturba Medical College  Department of Nephrology, Kasturba medical college, Manipal-576104
Udupi
KARNATAKA 		 7337298748

shayoli.kmcmpl2024@learner.manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba medical college and kasturba hospital institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N179||Acute kidney failure, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  All adult patients with AKI (Stage II and Stage III) who are 18 years of age or older (according to the KDIGO creatinine criteria from 2012) who are discharged alive after hospitalization for an acute/chronic illness will be included (irrespective of degree of recovery from AKI at discharge). 
 
ExclusionCriteria 
Details  Patients with transient AKI (AKI that resolves within 48 hours of onset, as defined by KDIGO), known Chronic kidney disease (CKD) that already existed (or imaging suggestive of CKD), those with previous history of AKI (defined as one or more episodes of AKI known to have occurred in the past five years), those with acute glomerulonephritis, kidney transplant recipients and those who do not consent for participation and subsequent follow-up will be excluded. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
New onset CKD is defined as (eGFR less than 60 mL/min/1.73 m2, as assessed by the CKD-EPI formula or a random urine protein to-creatinine ratio more than 150 mg/g.  At baseline,12 months and 24 months 
 
Secondary Outcome  
Outcome  TimePoints 
1. To analyse cardiovascular & all-cause mortality rates & risk factors among AKI survivors.
2. To assess the knowledge of AKI in survivors of an AKI episode using a validated questionnaire.
3. To explore AKI experience & potential barriers to post discharge AKI care in survivors of an AKI episode.
4. To study the incidence of new onset hypertension, recurrent AKI & hospitalizations in AKI survivors.
 		 Secondary objective 1:At baseline, 12 months & 24 months
Secondary objective 2:At baseline, 6 months
Secondary objective 3:At baseline, 6 months
Secondary objective 4:At baseline, 12 months & 24 months
 
 
Target Sample Size   Total Sample Size="640"
Sample Size from India="640" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/04/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Acute Kidney Injury (AKI) affects approximately 13.3 million people globally each year, with a higher prevalence in low- and middle-income countries (LMICs). Despite evidence linking AKI to chronic kidney disease  and long-term adverse outcomes, most studies focus on high-income countries. Limited data exist on post-AKI recovery, patient-reported outcomes, and follow-up care in LMICs, particularly India. This study aims to fill this knowledge gap by evaluating the long-term consequences of AKI, risk factors for CKD, and barriers to post-discharge care among AKI survivors. The Primary Objective is to estimate the incidence of new-onset CKD in AKI survivors. The Secondary Objectives are: To analyse cardiovascular and all-cause mortality rates among AKI survivors, to study new-onset hypertension, recurrent AKI, and hospitalization rates post-AKI. To assess AKI knowledge and awareness using a validated questionnaire among AKI survivors and to identify barriers to post-discharge AKI care through qualitative interviews. Study Design: Prospective cohort study at Kasturba Hospital, Manipal. Population: Adults (greater than or equal to eighteen years) with AKI (Stage II/III) surviving hospitalization. Sample Size: Six hundred and forty patients. The Baseline data such as: Demographics, clinical history, AKI severity, laboratory markers will be collected. Follow-ups: three-months and annually, assessing kidney function, hypertension, hospitalizations, and mortality. Qualitative Study: In-depth interviews with approximately thirty AKI survivors to explore barriers to care. Statistical Analysis: Logistic regression models and subgroup analyses. Expected Outcomes & Significance of the study includes Identification of CKD risk factors post-AKI to improve early intervention, Increased awareness of AKI’s long-term effects to guide follow-up care. Insights into patient experiences and healthcare gaps to inform policy changes.   
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