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CTRI Number  CTRI/2024/01/061610 [Registered on: 18/01/2024] Trial Registered Prospectively
Last Modified On: 08/05/2026
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Development of a prediction tool for kidney injury in patients with respiratory disorder on different ventilation techniques.  
Scientific Title of Study   Development and validation of a prediction tool for acute kidney injury in spontaneous Vs controlled ventilation patients with moderate to severe acute respiratory distress syndrome  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vishal Shanbhag 
Designation  Associate Professor  
Affiliation  Kasturba Medical College, Manipal Academy of Higher Education, Manipal 
Address  ICU-2, Department of Critical Care Medicine, Kasturba Medical College, MAHE, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9901960496  
Fax    
Email  vishal.shanbhag@manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Vishal Shanbhag 
Designation  Associate Professor  
Affiliation  Kasturba Medical College, Manipal Academy of Higher Education, Manipal 
Address  ICU-2, Department of Critical Care Medicine, Kasturba Medical College, MAHE, Manipal


KARNATAKA
576104
India 
Phone  9901960496  
Fax    
Email  vishal.shanbhag@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Vishal Shanbhag 
Designation  Associate Professor  
Affiliation  Kasturba Medical College, Manipal Academy of Higher Education, Manipal 
Address  ICU-2, Department of Critical Care Medicine, Kasturba Medical College, MAHE, Manipal


KARNATAKA
576104
India 
Phone  9901960496  
Fax    
Email  vishal.shanbhag@manipal.edu  
 
Source of Monetary or Material Support  
Manipal Academy of Higher Education 
 
Primary Sponsor  
Name  Faculty SEED grant- Manipal Academy of Higher Education 
Address  Manipal Academy of Higher Education, Madhav Nagar, Manipal 576104 
Type of Sponsor  Research institution and hospital 
 
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 Souvik Chaudhuri  Kasturba Medical College and Kasturba Hospital  Intensive care units 1,2,3- Department of Critical Care Medicine, Madhav Nagar, Manipal
Udupi
KARNATAKA 		 9937178620

souvik.chaudhuri@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: N178||Other acute kidney failure,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil   Nil  
Comparator Agent  Nil   Nil  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  ARDS patients who receive either oxygen therapy, non-invasive ventilation or invasive ventilation (endotracheal or tracheostomy) within the first 24 hours of diagnosis.
Patients should have an acute decrease in ratio of partial pressure of arterial
oxygen to fraction of inspired oxygen of less than or equal to 200.
Evidence of bilateral pulmonary infiltrates on a chest radiograph consistent with
ARDS
C-reactive protein levels less than 50mg per L
Bedside ultrasonogram confirming normal kidneys on admission.  
 
ExclusionCriteria 
Details  No past history of kidney injury, obstructive nephropathy, pyelonephritis, circulatory
shock requiring vasopressors, cardio-respiratory arrest or IV contrast which can
contribute to AKI.
No history of nephrotoxic drugs for the past 2 weeks
Patients with any mode of ventilation less than 24 hours received from outside hospital.
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Prevalence of acute kidney injury among spontaneous or controlled ventilation patients with ARDS   Blood and urine samples will be collected within 12-24 hours of time of admission  
 
Secondary Outcome  
Outcome  TimePoints 
To determine the feasibility of using the inflammatory and urinary biomarkers for predicting acute kidney injury in moderate to severe ARDS patients who are on spontaneous or controlled ventilation and develop a prediction tool   12-24 hours of admission 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   19/01/2024 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Completed 
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   AKI is a vexing clinical problem, as it is difficult to diagnose before there is a loss of organ function, which later becomes irreversible. Incidence of AKI in ARDS patients varies from 25-75%, and it contributes to high mortality among ARDS patients. Available therapies are mainly based on supportive measures and removal of nephrotoxic agents. Acute Respiratory Distress Syndrome (ARDS) is an inflammatory syndrome of the lung with a mortality rate of 35-65%. Mortality from Acute Lung Injury (ALI) and ARDS is approximately 40-50%. Since atelectasis and edema reduce aerated lung volumes in patients with ALI and ARDS, inspiratory airway pressures are often high, suggesting the presence of excessive distention or stretch of aerated lung. Ventilation-induced kidney injury (VIKI) is thought to occur due to changes in the hemodynamic pattern that impair renal perfusion, neurohumoral mediated alterations in intra-renal blood flow, and systemic inflammatory mediators generated by ventilator-induced lung injury. This could be the result of organ cross-talk during systemic inflammatory response. This presents clinicians with limited means to identify the optimal ventilator strategy for each patient. It is known that the ventilatory strategy could augment serum levels of inflammatory mediators due to alveolar stretch and endothelial injury. Still, there is a lack of understanding of its plasma concentration levels correlating with the development of VIKI. As a result, we aimed to develop and validate a prediction tool for acute kidney injury in spontaneous Vs controlled ventilation patients with moderate to severe acute respiratory distress syndrome. 
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