| CTRI Number |
CTRI/2018/08/015202 [Registered on: 06/08/2018] Trial Registered Prospectively |
| Last Modified On: |
05/08/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
STUDY OF FACTORS RESPONSIBLE FOR ACUTE KIDNEY INJURY IN ICU SETUP |
|
Scientific Title of Study
|
Study of clinical profile and outcomes of Acute kidney injury in intensive care units of a Tertiary care hospital |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ANIL KUMAR CHETLAPALLI |
| Designation |
DM NEPHROLOGY |
| Affiliation |
kasturbha medical coolege |
| Address |
room no:15,nephrology opd,kasturbha medical college,manipal,karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9985788966 |
| Fax |
9985788966 |
| Email |
chanilkumar2007@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
DRRAVINDRA PRABHU |
| Designation |
PROFESSOR AND HOD |
| Affiliation |
kasturba medical college |
| Address |
room no:15,nephrology opd,kasturbha medical college,manipal,karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
08202922442 |
| Fax |
|
| Email |
aravindraprabhu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
ANIL KUMAR CHETLAPALLI |
| Designation |
DM NEPHROLOGY |
| Affiliation |
kasturbha medical coolege |
| Address |
room no:15,nephrology opd,kasturbha medical college,manipal,karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9985788966 |
| Fax |
9985788966 |
| Email |
chanilkumar2007@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
ANIL KUMAR CHETLAPALLI |
| Address |
room no:15,nephrology opd,kasturbha medical college,manipal,karnataka |
| Type of Sponsor |
Other [PRINCIPAL INVESTIGATOR] |
|
|
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 |
| ANIL KUMAR CHETLAPLLI |
KASTURBHA MEDICAL COLLEGE |
KASTURBHA MEDICAL COLLEGE MANIPAL
Udupi
KARNATAKA |
9985788966
chanilkumar2007@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KMC and KH Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
patients admitted under intensive care , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patient admitted to ICU with wide variety of medical & surgical disorders necessitating ICU care.
An change in serum creatinine by ≥0.3 mg/dL (27 micromol/L) within 48 hours or an increase to ≥1.5 times the presumed baseline value that is known or presumed to have occurred within the prior seven days,
A decrease in urine volume to <3 mL/kg over six hours
Need for Renal replacement therapy. Informed written consent to be taken from first degree relatives of the patients or any authorized person
|
|
| ExclusionCriteria |
| Details |
All patients with age <18,
Baseline serum creatinine ≥5.0 mg/dL,
End-stage renal disease (ESRD) on dialysis,
Transplanted kidney were excluded from the study
Patients with chronic kidney disease
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| death |
3months ,6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| worsened renal function, which was defined as 25% or greater decline in eGFR, |
3months,6months |
| new dialysis |
3months and 6 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
07/08/2018 |
| 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="6"
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
|
Acute
kidney injury is one of the common complications seen in ICU patients. It is
associated with high morbidity & mortality. It is crucial to establish the
different etiological condition by the history & clinical presentation to
arrive at proper clinical diagnosis & management, which helps us to reduce
the morbidity & mortality in ICU setup. Hence, data about the incidence and outcome of AKI
patients can have important health resource utilization and economic
implications. |