| CTRI Number |
CTRI/2024/03/064020 [Registered on: 12/03/2024] Trial Registered Prospectively |
| Last Modified On: |
17/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study to compare outcomes of Obstetric versus non Obstetric Acute Kidney Injury in a Tertiary Care Hospital |
|
Scientific Title of Study
|
Comparative Outcomes of Obstetric versus Non Obstetric Acute Kidney Injury in a Tertiary Care Hospital |
| 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 Beauty Suman |
| Designation |
DM Senior Resident |
| Affiliation |
ATAL BIHARI VAJAPAYEE INSITUTE OF MEDICAL SCIENCE AND DR RAM MANOHAR LOHIA HOSPITAL |
| Address |
Department of Nephrology
Atal Bihari Vajapayee institute of medical science and Dr Ram Manohar Lohia Hospital
Baba Kharak Singh road
New Delhi
New Delhi
DELHI
110001
India |
| Phone |
9953392829 |
| Fax |
|
| Email |
beautysuman.doc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Lalit K Pursnani |
| Designation |
Professor |
| Affiliation |
ATAL BIHARI VAJAPAYEE INSTITUTE OF MEDICAL SCIENCES AND RAM MANOHAR LOHIA HOSPITAL |
| Address |
Department of Nephrology
Atal Bihari vajapayee institute of medical science and Dr Ram Manohar Lohia Hospital
Baba Kharak Singh Road
New Delhi
New Delhi
DELHI
110001
India |
| Phone |
09958268930 |
| Fax |
|
| Email |
drlalitkpursnani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Beauty Suman |
| Designation |
DM Resident |
| Affiliation |
ATAL BIHARI VAJAPAYEE INSTITUTE OF MEDICAL SCIENCES AND RAM MANOHAR LOHIA HOSPITAL |
| Address |
Department of Nephrology
Atal Bihari Vajpayee institute of medical science and Dr Ram Manohar Lohia Hospital Baba Kharak Singh Road
New Delhi
New Delhi
DELHI
110001
India |
| Phone |
9953392829 |
| Fax |
|
| Email |
beautysuman.doc@gmail.com |
|
|
Source of Monetary or Material Support
|
| Atal Bihari Vajpayee institute of medical science and Dr Ram Manohar Lohia Hospital New Delhi |
|
|
Primary Sponsor
|
| Name |
Atal Bihari Vajpayee institute of medical science and Dr Ram Manohar Lohia Hospital |
| Address |
Department of Nephrology
Atal Bihari Vajpayee institute of medical science and Dr Ram Manohar Lohia Hospital New Delhi-110001 |
| 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 Beauty Suman |
Atal Bihari Vajpayee institute of medical science and Dr Ram Manohar Lohia Hospital |
Department of Nephrology
Atal Bihari Vajpayee institute of medical science and Dr Ram Manohar Lohia Hospital
Baba Kharak Singh Road
New Delhi-110001
New Delhi
DELHI |
9953392829
beautysuman.doc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethic Committee, Atal Bihari Vajpayee institute of medical science and Dr Ram Manohar Lohia Hospital New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N17||Acute kidney failure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable
Its an observational study |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Non obstetric cases:
A) rise in serum creatinine by more than 0.3mg/dl within 48 hours
B) rise in serum creatinine to more than 1.5 times baseline, which is known or presumed to have occured within the prior 7 days
C) urine volume less than 0.5ml/kg/h for 6 hours.
Obstetric cases:
All pregnant female and postpartum till 42 days with
A) rise in serum creatinine by more than 0.3mg/dl within 48 hours
B) rise in serum creatinine to more than 1.5 times baseline, which is known or presumed to have occured within the prior 7 days
C) urine volume less than 0.5ml/kg/h for 6 hours. |
|
| ExclusionCriteria |
| Details |
1) patients with proven end stage renal disease
2) patients on maintenance hemodialysis
3) when baseline was not available and patient died before renal recovery
4) patients with known chronic kidney disease
5) renal transplant |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| outcomes of acute kidney injury in obstetric and non obstetric cases in terms of dialysis dependency, progression to chronic kidney disease and mortality |
outcomes of acute kidney injury in obstetric and non obstetric cases in terms of dialysis dependency, progression to chronic kidney disease and mortality at day 7, day 30 and day 90 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study various etiologies of acute kidney injury presenting in a tertiary care hospital |
follow up at dat 7, day 30 and day 90 |
|
|
Target Sample Size
|
Total Sample Size="118"
Sample Size from India="118"
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)
|
20/03/2024 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Patients will be recruited as per inclusion and exclusion criteria and all the details will be noted as per proforma. Then Patient will be followed up at day 7, day 30 and day 90 for outcomes. |