| CTRI Number |
CTRI/2024/04/065219 [Registered on: 04/04/2024] Trial Registered Prospectively |
| Last Modified On: |
27/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Prediction of risk of Acute Kidney Injury in the Intensive Care Unit. |
|
Scientific Title of Study
|
Prediction of risk of Acute Kidney Injury in the Intensive Care Unit using an AKI risk prediction tool- an 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 |
Vaddadi Ravitej |
| Designation |
DrNB student |
| Affiliation |
Apollo hospitals |
| Address |
Department of critical care medicine, Apollo hospitals, 21, Greams Lane, Off Greams Road, Chennai, Tamil Nadu-600006
Chennai
TAMIL NADU
600006
India |
| Phone |
7799512333 |
| Fax |
|
| Email |
ravitejvaddadi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr R Senthil Kumar |
| Designation |
Consultant |
| Affiliation |
Apollo Hospital |
| Address |
Department of critical care medicine, Apollo hospitals, 21, Greams Lane, Off Greams Road, Chennai, Tamil Nadu-600006
Chennai
TAMIL NADU
600006
India |
| Phone |
9444927291 |
| Fax |
|
| Email |
rskumaricu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vaddadi Ravitej |
| Designation |
DrNB student |
| Affiliation |
Apollo Hospital |
| Address |
Department of critical care medicine, Apollo hospitals, 21, Greams Lane, Off Greams Road, Chennai, Tamil Nadu-600006
Chennai
TAMIL NADU
600006
India |
| Phone |
7799512333 |
| Fax |
|
| Email |
ravitejvaddadi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Apollo Hospitals, 21, Greams Road, Chennai |
|
|
Primary Sponsor
|
| Name |
Apollo Hospital |
| Address |
Department of critical care medicine, Apollo hospitals, 21, Greams Lane, Off Greams Road, Chennai, Tamil Nadu-600006 |
| 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 Vaddadi Ravitej |
Apollo Hospitals |
Department of critical care medicine, Apollo hospitals, 21, Greams Lane, Off Greams Road, Chennai, Tamil Nadu-600006
Chennai
TAMIL NADU |
7799512333
ravitejvaddadi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee- Bio medical research, Apollo Hospitlas, AHEL, Chennai, Tamil Nadu |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A00-B99||Certain infectious and parasitic diseases, (2) ICD-10 Condition: C00-D49||Neoplasms, (3) ICD-10 Condition: D50-D89||Diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism, (4) ICD-10 Condition: G00-G99||Diseases of the nervous system, (5) ICD-10 Condition: I00-I99||Diseases of the circulatory system, (6) ICD-10 Condition: J00-J99||Diseases of the respiratory system, (7) ICD-10 Condition: K00-K95||Diseases of the digestive system, (8) ICD-10 Condition: L00-L99||Diseases of the skin and subcutaneous tissue, (9) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, (10) ICD-10 Condition: N00-N99||Diseases of the genitourinary system, (11) ICD-10 Condition: S00-T88||Injury, poisoning and certain other consequences of external causes, (12) ICD-10 Condition: Q00-Q99||Congenital malformations, deformations and chromosomal abnormalities, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All patients above 18years admitted in icu during study period |
|
| ExclusionCriteria |
| Details |
AKI on icu admission, CKD stage 5, Patients on Hemodialysis, Post Renal Transplant patients. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the predictive ability of malhotra score in predicting the incidence of AKI within 7 days of admission in icu. |
For a period of 7 days from the time of admission or upto their discharge from ICU, whichever occurs first. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Length of ICU stay in ICU |
For a period of 7 days from the time of admission or upto their discharge from ICU, whichever occurs first. |
| Need for renal replacement therapy in ICU |
For a period of 7 days from the time of admission or upto their discharge from ICU, whichever occurs first. |
| ICU Mortality in patients who developed AKI |
For a period of 7 days from the time of admission or upto their discharge from ICU, whichever occurs first. |
|
|
Target Sample Size
|
Total Sample Size="238"
Sample Size from India="238"
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)
|
15/04/2024 |
| 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)
|
Not Applicable |
| 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 - NO
|
|
Brief Summary
|
A Prospective Observational study, to predict the risk of development of Acute Kidney Injury in patients getting admitted in ICU using an AKI risk prediction tool. The risk prediction tool being used in this study is the malhotra score, which will be calculated for the first 2 days and patients will be followed up for 7 days or their discharge from icu, whichever occurs first. We evaluate the Predictive ability of the Malhotra Score in predicting the incidence of AKI within 7 days using changes in serum creatinine and urine output at the end of study. |