| CTRI Number |
CTRI/2022/06/043290 [Registered on: 15/06/2022] Trial Registered Prospectively |
| Last Modified On: |
14/06/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To find out causes , symptoms , complications and outcome in patients of Acute Kidney Failure |
|
Scientific Title of Study
|
Study OF Etiology , Clinical profile , Complications And Outcome in patients of Acute Kidney Injury |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR AFFAN ALI KHAN |
| Designation |
PG SCHOLAR |
| Affiliation |
School of medicine , Dr D Y Patil deemed to be university |
| Address |
Department of medicine , School of medicine , Dr D.Y. Patil hospital and deemed to be university , Sector -5 Nerul , Navi mumbai.
Thane
MAHARASHTRA
400706
India |
| Phone |
9059548087 |
| Fax |
|
| Email |
affan1494@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ravindra Nath Sahay |
| Designation |
Professor |
| Affiliation |
School of medicine , Dr D Y Patil deemed to be university |
| Address |
Department of medicine , School of medicine , Dr D.Y. Patil hospital and deemed to be university , Sector -5 , Nerul , Navi mumbai.
Thane
MAHARASHTRA
400706
India |
| Phone |
9820061099 |
| Fax |
|
| Email |
drrnsahay@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR AFFAN ALI KHAN |
| Designation |
PG SCHOLAR |
| Affiliation |
School of medicine , Dr D Y Patil deemed to be university |
| Address |
Department of medicine , School of medicine , Dr D.Y. Patil hospital and deemed to be university , Sector -5 Nerul , Navi mumbai.
Thane
MAHARASHTRA
400706
India |
| Phone |
9059548087 |
| Fax |
|
| Email |
affan1494@gmail.com |
|
|
Source of Monetary or Material Support
|
| School of medicine , D.Y PATIL deemed to be university |
|
|
Primary Sponsor
|
| Name |
Dr AFFAN ALI KHAN |
| Address |
Department of medicine , School of medicine , Dr D.Y. Patil hospital and deemed to be university , Sector -5 Nerul , Navi mumbai. |
| 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 |
| DR AFFAN ALI KHAN |
School of Medicine , DR D Y Patil , DY patil deemed to be university |
Department of medicine , School of medicine , Dr D.Y. Patil hospital and deemed to be university , Sector -5 Nerul , Navi mumbai .
Thane
MAHARASHTRA |
9059548087
affan1494@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
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with Acute Kidney Injury clinically diagnosed when the serum Creatinine increases to more than 2 mg/100 ml with or without oliguria
2.Patients with steady increase in serum Creatinine concentration of atleast 1 mg/ 100 ml over 48 hours
3.Patients with an increase in serum Creatinine by more than 20 % per day if baseline is more than 2.5 mg/100 ml |
|
| ExclusionCriteria |
| Details |
1.Patients less than 18 years of age
2.Patients with previous Renal transplantation
3.Patients with evidence of Contracted Kidneys on ultrasound scan of abdomen |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| All cause mortality |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Percentage of cases which progressed to chronic kidney disease |
10 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
29/06/2022 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
the present study is the clinical observational study for completion under DR DY PATIL deemed to be university total duration of trial is 1 year
TITLE : STUDY of Etiology , Clinical profile , Complications and Outcome in Patients of acute kidney injury
STUDY GROUP : Sample size 200
STUDY CENTER : School of medicine Dr. DY PATIL deemed to be university and hospital , nerul , navimumbai
PG scholar : DR. AFFAN ALI KHAN
GUIDE : DR. RAVINDRA NATH SAHAY |