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CTRI Number  CTRI/2024/03/063731 [Registered on: 06/03/2024] Trial Registered Prospectively
Last Modified On: 05/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Outcome of patients with severe pneumonia in ICU 
Scientific Title of Study   Utility of the Mechanical Power (MP) of the ventilator versus Driving Pressure, Oxygenation, and Nutritional Evaluation (DRONE) score as a predictor of mortality, and non-resolving sub-phenotype of acute kidney injury (AKI) among ARDS patients: a prospective observational 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  Dr Pratik Paran Medhi 
Designation  DM Registrar 
Affiliation  Kasturba Medical College,Manipal,Manipal Academy of Higher Education  
Address  Department of Critical Care, Kasturba Medical College, Madhav Nagar, Manipal, Udupi District, Karnataka

Udupi
KARNATAKA
576104
India 
Phone  6002355458  
Fax    
Email  drpratikmedhi@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shwethapriya R  
Designation  Professor and Head Of The Department 
Affiliation  Kasturba Medical College,Manipal, Manipal Academy of Higher Education  
Address  Department of Critical Care, Kasturba Medical College, Madhav Nagar, Manipal, Udupi District, Karnataka

Udupi
KARNATAKA
576104
India 
Phone  6002355458  
Fax    
Email  shwethapriya.rao@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Pratik Paran Medhi 
Designation  DM Registrar 
Affiliation  Kasturba Medical College,Manipal,Manipal Academy of Higher Education  
Address  Department of Critical Care, Kasturba Medical College, Madhav Nagar, Manipal, Udupi District, Karnataka


KARNATAKA
576104
India 
Phone  6002355458  
Fax    
Email  drpratikmedhi@gmail.com  
 
Source of Monetary or Material Support  
Kasturba Medical College and Kasturba Hospital Manipal, Madhav Nagar, Manipal, PIN-576104, Karnataka , India 
 
Primary Sponsor  
Name  Dr Pratik Paran Medhi 
Address  Department of Critical Care, Kasturba Medical College, Madhav Nagar, Manipal, Karnataka  
Type of Sponsor  Other [Self] 
 
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 Pratik Paran Medhi   Kasturba Hospital, Manipal  Department of Critical Care, First Floor, Trauma and Emergency Block, Udupi, Karnataka
Udupi
KARNATAKA 
6002355458

drpratikmedhi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committe  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J80||Acute respiratory distress syndrome,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  ARDS as diagnosed by Berlin’s criteria. 
 
ExclusionCriteria 
Details  Patients with ARDS diagnosis more than 48 hours.
Patients of ARDS who are not on invasive mechanical ventilation (IMV).
Pregnant patients with ARDS.
Patients with known CKD or diagnosed CKD in hospital, where the AKI sub-phenotype based
on creatinine trajectories will be unreliable.
Patients of pneumothorax where lung ultrasound score will be unreliable. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Mortality of the patient  28 days after ICU admission 
 
Secondary Outcome  
Outcome  TimePoints 
Need for Renal Replacement Therapy due to Acute Kidney Injury.   7 days after ICU admission.  
 
Target Sample Size   Total Sample Size="137"
Sample Size from India="137" 
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)   21/03/2024 
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="1"
Months="6"
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  
After written informed consent from the legally authorized representatives, adult patients aged
18-90 years of either gender, diagnosed with ARDS on invasive mechanical ventilation will be
recruited for the study. The demographic parameters – age, gender, co-morbidities, APACHE II
score, SOFA score, lung ultrasound score, and KDIGO score will be noted.
On day 2 (24-48 hours) of ARDS diagnosis, the following will be noted:
1. The DRONE score of the patients based on the worst value of Driving Pressure between
24-48 hours after ARDS diagnosis.
2. The Mechanical Power (MP) of the ventilator – the highest MP recorded between 24-48
hours of ventilation will be noted.
On VCV, the MP of the ventilator will be calculated as:
(J/min)=0.098 * RR* Vt* (PEEP+1⁄2 [P plat − PEEP]+[P peak – P plat])
MP = 0.098*RR*Vt *{Peak inspiratory pressure – 0.5 [P plateau-PEEP]
On PCV, the MP of the ventilator will be calculated as:
MP = 0.098*RR*Vt*{PEEP + ΔP insp}, where ΔPinsp is the pressure (cmH2O) above
PEEP during pressure-controlled ventilation.
3. The serum creatinine levels will be determined from day 1, 3, 5, and the last day of ICU
stay of the ARDS patient.
4. Standard of care investigations like complete blood picture, renal function tests, serum
electrolytes- sodium, potassium, C-reactive protein, procalcitonin, total bilirubin, albumin
and echocardiography parameters will be recorded.

5. The worst lung ultrasound score will be recorded from the 12 lung regions bilaterally and
the highest renal arterial resistive index will be noted between 24-48 hours of ARDS
diagnosis.
6. Need for renal replacement therapy, endotracheal, blood, urine, and pus culture reports,
need for prone ventilation, and net fluid balance at 48 hours of ARDS diagnosis will be
noted.
7. Days of ventilator support, ICU stay and mortality outcomes will be noted.
8. If the patient requires prone position ventilation due to severe ARDS, then the MP of the
ventilator will be noted before and after the prone position ventilation sessions. Primary- Mortality at 28 days from ARDS diagnosis.
Secondary- Need for RRT, non resolving AKI sub phenotype.

 
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