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CTRI Number  CTRI/2020/03/023922 [Registered on: 12/03/2020] Trial Registered Prospectively
Last Modified On: 25/02/2020
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   Comparison of etiology clinical characteristics and outcomes of community acquired acute kidney injury and hospital acquired acute kidney injury 
Scientific Title of Study   A study to compare the etiology clinical characteristics and the outcomes of Community-Acquired Acute Kidney Injury CAAKI and Hospital Acquired Acute Kidney Injury HAAKI among the patients admitted to Critical Care Units of selected tertiary care hospital of Udupi district  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  AlexDenzil P Huggi 
Designation  Nurse Practitioner in Critical Care Student 
Affiliation  Manipal College of Nursing MAHE Manipal 
Address  Manipal College of Nursing Manipal Madhava Nagar Manipal

Udupi
KARNATAKA
576104
India 
Phone  09008127916  
Fax    
Email  alex.denzil@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Janet Prameela DSouza 
Designation  Assistant Professor 
Affiliation  Manipal College of Nursing Manipal MAHE Manipal 
Address  Manipal College of Nursing Manipal Madhava Nagar Manipal

Udupi
KARNATAKA
576104
India 
Phone  09986417306  
Fax    
Email  janet.p@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Janet Prameela DSouza 
Designation  Assistant Professor 
Affiliation  Manipal College of Nursing Manipal MAHE Manipal 
Address  Manipal College of Nursing Manipal Madhava Nagar Manipal

Udupi
KARNATAKA
576104
India 
Phone  09986417306  
Fax    
Email  janet.p@manipal.edu  
 
Source of Monetary or Material Support  
Kasturba Medical College and Kasturba Hospital manipal MAHE MAnipal 
 
Primary Sponsor  
Name  AlexDenzil P Huggi 
Address  Manipal College of Nursing MAHE Manipal 
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 
AlexDenzil P Huggi  Department of Critical Care ICU Emergency Medicine ICU Medicine ICU Cardiology ICU   Kasturba Hospital Manipal Karnataka
Udupi
KARNATAKA 
9008127916

alex.denzil@gmail.com 
 
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 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients admitted to critical care units
Patients with age group from 18 years to 70 years
 
 
ExclusionCriteria 
Details  Patients with acute on chronic kidney disease or renal failure attributed to chronic kidney disease.
Patients with pre-existing kidney diseases
Patients with other renal pathology
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Short term mortality, discharge from the hospital, no of days in ICU or recovery among HAAKI and CAAKI patients.  after 15 days 
 
Secondary Outcome  
Outcome  TimePoints 
Not applicable   Not applicable 
 
Target Sample Size   Total Sample Size="260"
Sample Size from India="260" 
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)   15/03/2020 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not yet recruited 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

The patients will be recruited for the study based on inclusion and exclusion criteria. The participant information sheet will be explained to the patient or to relatives. Consent will be obtained from the patient or the relative. Acute kidney injury status will be assessed using Kidney Disease Improving Global Outcome KDIGO scale.  Etiological factors will be identified, using the risk assessment tool. Clinical characteristics will be assessed using the Checklist at baseline and for 15 days on a daily basis. APACHE II scale will be used at baseline to predict mortality. Follow up will be done after 15 days to check for outcome in terms of the number of days of ICU stay, mortality and discharge from the hospital.


 
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