CTRI Number |
CTRI/2021/11/037925 [Registered on: 10/11/2021] Trial Registered Prospectively |
Last Modified On: |
07/11/2021 |
Post Graduate Thesis |
Yes |
Type of Trial |
Observational |
Type of Study
|
Follow Up Study |
Study Design |
Single Arm Study |
Public Title of Study
|
risk factors for infection associated kidney damage in icu patients |
Scientific Title of Study
|
risk factors for sepsis associated acute kidney injury in adults admitted to icu |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Girish kumar J |
Designation |
Pg student , Dnb superspeciality in critical care medicine |
Affiliation |
Gangaram hospitals |
Address |
Sir gangaram hospital,Department of critical care and emergency medicine, 4th floor,ssrb block, new delhi Sir gangaram hospital, department of critical care and emergency medicine, 4 floor ssrb new delhi New Delhi DELHI 110060 India |
Phone |
01142252451 |
Fax |
|
Email |
mailtogirishj@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Girish kumar J |
Designation |
Pg student , Dnb superspeciality in critical care medicine |
Affiliation |
Sir gangaram hospital |
Address |
Sir gangaram hospital, dept of critical care emerge medicine,4th floor,ssrb block, new delhi Sir gangaram hospital, department of critical care and emergency medicine, 4 floor, ssrb block, new delhi New Delhi DELHI 110060 India |
Phone |
01142252451 |
Fax |
|
Email |
mailtogirishj@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Girish kumar J |
Designation |
Pg student , Dnb superspeciality in critical care medicine |
Affiliation |
Sir gangaram hospital |
Address |
Sir gangaram hospital, dept of criticalcare and emergency medicine, 4th floor,ssrb block, new delhi Sir gangaram hospital, department of critical care and emergency medicine. 4 floor ,ssrb block Central DELHI 110060 India |
Phone |
01142252451 |
Fax |
|
Email |
mailtogirishj@gmail.com |
|
Source of Monetary or Material Support
|
material support from sir ganga ram hospital |
|
Primary Sponsor
|
Name |
sir ganga ram hospital |
Address |
central delhi
new delhi |
Type of Sponsor |
Private hospital/clinic |
|
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 prakash shastri |
icu, sir ganga ram hospital |
Room no 2400,4th floor,ssrb block
sir ganga ram hospital Central DELHI |
9810937295
prakashshastri@live.in |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
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 |
all adult icu patients developing aki in sepsis |
|
ExclusionCriteria |
Details |
ckd receiving dialysis
organ donor or transplant patients
pre existing aki at the onset of shock |
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Case Record Numbers |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
Risk factors associated SA-AKI |
90 days |
|
Secondary Outcome
|
Outcome |
TimePoints |
resolution of AKI
ICU and hospital length of stay
Development of CKD by 90 days
In hospital and 90 day mortality |
90 days from the icu admission
untilresolution of aki
|
|
Target Sample Size
|
Total Sample Size="156" Sample Size from India="156"
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 1 |
Date of First Enrollment (India)
|
10/11/2021 |
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 Yet Recruiting |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol Response - Informed Consent Form Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [mailtogirishj@gmail.com].
- For how long will this data be available start date provided 23-12-2022 and end date provided 23-11-2028?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
Brief Summary
|
Sepsis associated acute kidney injury is a syndrome of acute loss of renal function, defined by the simultaneous presence of both Sepsis and renal dysfunction as per KDIGO criteria. Severe sepsis and septic shock are the main causes of acute kidney injury (AKI) in the intensive care unit (ICU). The treatment of AKI is supportive. No generally accepted guidelines for indication or optimal timing for initiation of renal replacement therapy (RRT) exist. Apart from life-threatening indications, the initiation of RRT is mainly based on clinical judgment.The long-term mortality of hospital survivors with AKI remains increased for several years after critical illness. Risk and outcomes for sepsis associated AKI in adult patients admitted to ICU has not been systematically evaluated. The objectives of this study is to assess the association of risk factors and outcome of ICU patients with sepsis associated AKI. All consecutive adults admitted to ICU with suspected infection, along with SOFA score >6 or acute increase in SOFA score by >2 or culture positive sepsis will be enrolled. We will use KDIGO criteria to define AKI during ICU stay. The enrolled patients will be followed till ICU/Hospital discharge, ICU or hospital mortality, resolution of AKI, death or survival at day 90 from entry, and for long term outcome of the development of chronic kidney disease. We will collect data on multiple variables and risk factors. |