| CTRI Number |
CTRI/2024/05/067041 [Registered on: 08/05/2024] Trial Registered Prospectively |
| Last Modified On: |
07/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
An observational study to find out spectrum of Acute kidney injury in intensive care units and its effect on mortality of the patients. |
|
Scientific Title of Study
|
Spectrum And Outcome Of Acute Kidney Injury In Patients Admitted To Intensive Care
Unit Of A Tertiary Care Hospital In North India |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sana Masroor |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Department of Anaesthesiology and critical care, Jawaharlal Nehru Medical College, Aligarh Muslim University, Aligarh, Uttar Pradesh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
|
| Fax |
|
| Email |
sanamasroor2k9@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Abu Nadeem |
| Designation |
Associate Professor |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Department of Anaesthesiology and critical care, Jawaharlal Nehru Medical College, Aligarh Muslim University, Aligarh, Uttar Pradesh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9837757772 |
| Fax |
|
| Email |
drabunadeem@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Abu Nadeem |
| Designation |
Associate Professor |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Department of Anaesthesiology and critical care, Jawaharlal Nehru Medical College, Aligarh Muslim University, Aligarh, Uttar Pradesh
UTTAR PRADESH
202002
India |
| Phone |
9837757772 |
| Fax |
|
| Email |
drabunadeem@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Jawaharlal Nehru Medical College |
| Address |
Department of Anaesthesiology and Critical Care, Jawaharlal Nehru Medical College, Aligarh Muslim University, Aligarh |
| Type of Sponsor |
Government medical college |
|
|
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 |
| DR Sana Masroor |
Jawaharlal Nehru Medical College |
Department of Anaesthesiology and Critical Care, Jawaharlal Nehru Medical College, Aligarh Muslim University, Aligarh
Aligarh
UTTAR PRADESH |
9557808217
sanamasroor2k9@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| 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
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients with medical and surgical disorders requiring ICU care with AKI as defined by KDIGO criteria
Patients with medical and surgical disorders requiring ICU care with AKI as defined by:
Patients aged 18 years and above
A change in SCr by more than equal to 0.3 mg/dL within 48 h or an increase to more than equal to 1.5 times the presumed baseline value that is known or presumed to have occurred within the prior 7 days OR Urine output less than 0.5 ml/kg/hr for 6hrs |
|
| ExclusionCriteria |
| Details |
Patients aged less than 18 years
those with preexisting CKD stage
kidney transplant recipients were excluded |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the spectrum of Acute kidney Injury in patients admitted in the Intensive Care Unit |
6 hours post admission in icu
24 hours post admission in icu
48 hours post admission in icu |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the relationship of AKI with
-pre-existing comorbidities
- Renal replacement therapy
|
6 hours,24 hours,48 hours post admission in ICU |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
25/05/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
25/05/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This is an observational study about spectrum and outcome of Acute Kidney Injury in Intensive care Units of a Hospital in north india, 70 patients will be studied during the course of this study to find out the cause of ACUTE kidney injury and its association with co exisiting comorbidities in the patient .The need for renal replacement therapy in these patients will also be studied along with the outcome of AKI.this study will be conducted between 2023-2025. |