| CTRI Number |
CTRI/2024/12/078748 [Registered on: 30/12/2024] Trial Registered Prospectively |
| Last Modified On: |
25/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
“Impact of acute kidney injury (AKI) according to KDIGO staging criteria on survival in ICU patients†|
|
Scientific Title of Study
|
Impact of acute kidney injury (AKI) according to KDIGO staging criteria on 28-day mortality in critically ill patients: a prospective observational study |
| 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 Kshitija Kulshrestha |
| Designation |
DrNB resident, Critical care medicine |
| Affiliation |
BLK MAX Superspeciality Hospital, New Delhi |
| Address |
Department of Critical Care Medicine, BLK-MAX Superspeciality Hospital, Pusa Rd, Radha Soami Satsang, Rajendra Place, New Delhi
New Delhi DELHI 110005 India |
| Phone |
7038896834 |
| Fax |
|
| Email |
kshitijakul@yahoo.co.in |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Jitin Sharma |
| Designation |
Principal consultant, Critical care medicine |
| Affiliation |
BLK MAX Superspeciality Hospital, New Delhi |
| Address |
Department of Critical Care Medicine, BLK-MAX Superspeciality Hospital, Pusa Rd, Radha Soami Satsang, Rajendra Place, New Delhi
New Delhi DELHI 110005 India |
| Phone |
8800287026 |
| Fax |
|
| Email |
jitin.sharma@blkmaxhospital.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Kshitija Kulshrestha |
| Designation |
DrNB resident, Critical care medicine |
| Affiliation |
BLK MAX Superspeciality Hospital, New Delhi |
| Address |
Department of Critical Care Medicine, BLK-AX Superspeciality Hospital, Pusa Rd, Radha Soami Satsang, Rajendra Place, New Delhi
New Delhi DELHI 110005 India |
| Phone |
7038896834 |
| Fax |
|
| Email |
kshitijakul@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| BLK-MAX Superspeciality Hospital, Pusa Rd, Radha Soami Satsang, Rajendra Place, New Delhi, Delhi, 110005 |
|
|
Primary Sponsor
|
| Name |
N/A |
| Address |
N/A |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Kshitija Kulshrestha |
BLK-MAX Superspeciality hospital, Delhi |
Department of critical care medicine, BLK-MAX Superspeciality Hospital, Pusa Rd, Radha Soami Satsang, Rajendra Place, New Delhi, Delhi, 110005 Central DELHI |
07038896834
kshitijakul@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr. B. L. Kapur Memorial Hospital Ethics Commitee |
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 |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
95.00 Year(s) |
| Gender |
Both |
| Details |
Patients who have acute kidney injury on ICU admission or develop acute kidney injury during ICU stay |
|
| ExclusionCriteria |
| Details |
1.Pregnant patients
2.Patients with chronic kidney disease
3.Patients with renal or liver transplant
4.Terminally ill patients e.g., those suffering from advanced cancer
5.Mortality within 48 hours of ICU admission
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mortality |
28 day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Requirement of renal replacement therapy
|
hospital discharge/ mortality |
| Length of ICU & hospital stay |
hospital discharge/ mortality |
|
|
Target Sample Size
|
Total Sample Size="240" Sample Size from India="240"
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)
|
06/01/2025 |
| 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
|
N/A |
|
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan
- 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 [kshitijakul@yahoo.co.in].
- For how long will this data be available start date provided 02-12-2026 and end date provided 02-03-2029?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Acute
kidney injury is one of the most common organ impairments seen in intensive
care units. An estimated 7.5% of hospitalized population in South Asia develops
AKI. The incidence is much higher in ICU patients, varying from 1
in 3 to 2 in 3, based on the diagnostic criteria used. Acute kidney
injury is a concern for physicians given its association with increased length
of ICU stay, health care costs and in-hospital mortality in short term to
increased risks of cardiovascular events, progression to chronic kidney
disease, and long-term mortality. A strong and graded relationship between AKI
severity and increased mortality has been established.
Given
the significance of AKI on patient outcome, Risk, Injury, Failure, Loss,
End-Stage (RIFLE) criteria by Acute Dialysis Quality Initiative (ADQI) and later,
updated Acute Kidney Injury Network (AKIN) criteria aimed to define and stage
AKI. In 2012, Kidney Disease Improving Global
Outcomes (KDIGO) staging system was introduced which combined the
previous 2 systems and is currently the recommended system. These systems rely on
three diagnostic criteria: a rise in serum creatinine (SCr), a decrease in urine
output (UO), and administration of renal replacement therapy (RRT), to define
AKI into various stages.
However, it has been observed in various studies that KDIGO
criteria do not encompass all the factors that adversely affect patients with
AKI. Additionally, categorization of severity of AKI using KDIGO
criteria may not always be accurate.
We plan to perform a
prospective observational study on impact of AKI severity & other patient
and disease related factors on mortality, in critically ill patients. |