| CTRI Number |
CTRI/2018/12/016527 [Registered on: 05/12/2018] Trial Registered Prospectively |
| Last Modified On: |
29/05/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Observational Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to know the occurrence of acute kidney injury; how to determine it and its outcomes among patients admitted in critical care areas |
|
Scientific Title of Study
|
A study to assess the occurrence of acute kidney injury, its determinants and outcomes among patients admitted in critical care units in a selected tertiary care hospital in Manipal |
| Trial Acronym |
AKI |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Caroline Liyan Noronha |
| Designation |
Post graduate student |
| Affiliation |
Manipal College Of Nursing |
| Address |
Manipal College of Nursing
Manipal Academy of Higher Education
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9731084414 |
| Fax |
|
| Email |
crlnrnh1011@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jyothi Chakrabarty |
| Designation |
Professor |
| Affiliation |
Manipal College of Nursing |
| Address |
Manipal College of Nursing
Manipal Academy of Higher Education
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9880078542 |
| Fax |
|
| Email |
jyothi.r@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Mrs Latha T |
| Designation |
Assistant Professor Senior scale |
| Affiliation |
Manipal College of Nursing |
| Address |
Manipal College of Nursing
Manipal Academy of Higher Education
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9886398574 |
| Fax |
|
| Email |
latha.tbhat@manipal.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Caroline Noronha |
| Address |
Manipal College of Nursing
Manipal Academy of Higher education
Manipal 576104 |
| 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 |
| Caroline Noronha |
Kasturba Hospital |
ICU 1 (Bed No 1- 20)
Department of critical care medicine
Kasturba Hospital
Manipal 576104
Udupi
KARNATAKA |
9731084414
crlnrnh1011@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| 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 |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patients/ Legally Accepted Representative who gives the consent to participate in the study. |
|
| ExclusionCriteria |
| Details |
Patients with underlying chronic kidney disease undergoing regular dialysis
Patients whose ICU stay is less than 48 hours
Pregnant women
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Occurrence of acute kidney injury |
10 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| resolution of creatinine |
10 days |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
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)
|
01/01/2019 |
| 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="0"
Months="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a study to assess the occurrence of acute kidney injury among patients admitted in critical care units as well as to identify the determinants and outcomes of the disease. The determinants of the disease will be the primary diagnosis with which the patients gets admitted to the critical care unit. The outcomes are mortality, resolution of creatinine, dialysis dependancy of the patient. All the patients admitted to critical care units, whose stay in the ICU is more than 48 hours will be taken up for the study. These patients will be followed up for 10 days and the final outcome will be assessed on the day 10. Among these patients, the total number of patients who developed AKI will be reported along with other details such as the most common cause and treatment that was provided to the patient. |