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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: N179||Acute kidney failure, unspecified, |
|
Intervention / Comparator Agent
|
|
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. | |