| CTRI Number |
CTRI/2024/10/075006 [Registered on: 09/10/2024] Trial Registered Prospectively |
| Last Modified On: |
28/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective observational |
| Study Design |
Other |
|
Public Title of Study
|
Prediction of Outcomes for ICU-admitted patients of acute renal failure using the APACHE II score |
|
Scientific Title of Study
|
Assessment of APACHEII score to predict ICU outcomes of patients with Acute Kidney Injury (AKI) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sakshi Agrawal |
| Designation |
PG Student |
| Affiliation |
Dr SN Medical College |
| Address |
Department Of Anaesthesia
DR SN Medical College
Jodhpur RAJASTHAN 342001 India |
| Phone |
7976693491 |
| Fax |
|
| Email |
ninnisakshi92@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr. Neelam Meena |
| Designation |
Professor |
| Affiliation |
Dr. SN Medical College |
| Address |
Department Of Anesthesia
Dr. SN Medical College
Jodhpur RAJASTHAN 342001 India |
| Phone |
8302537601 |
| Fax |
|
| Email |
neelamneki1997@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Sakshi Agrawal |
| Designation |
PG Student |
| Affiliation |
Dr. SN Medical College |
| Address |
Department Of Anesthesia
Dr. SN Medical College
Jodhpur RAJASTHAN 342001 India |
| Phone |
7976693491 |
| Fax |
|
| Email |
ninnisakshi92@gmail.com |
|
|
Source of Monetary or Material Support
|
| MDM Hospital
Department of anaesthesia
DR SN Mediacal College
Jodhpur 342001 |
|
|
Primary Sponsor
|
| Name |
MDM Hospital Department of anaesthesia DR SN Mediacal College Jodhpur 342001 |
| Address |
Department of Anaesthesia
DR SN Medical College
Jodhpur
342001 |
| Type of Sponsor |
Government medical college |
|
|
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 Sakshi Agrawal |
MDM Hospital |
Multi level 2 ICU
MDM Hospital
Department of Anesthesia
DR SN Medical College
Jodhpur 342001 Jodhpur RAJASTHAN |
7976693491
ninnisakshi92@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instititional Ethics Committee Dr. Sampurnanand Medical College, Jodhpur |
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 |
Known case of AKI |
|
| ExclusionCriteria |
| Details |
Known case of CKD |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| mortality occurred or not occurred |
2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Analyzing the association between APACHE II scores & specific clinical factors, such as sepsis, organ dysfunction, & comorbidities, & their impact on outcomes, including mortality. |
2 weeks |
|
|
Target Sample Size
|
Total Sample Size="45" Sample Size from India="45"
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)
|
10/10/2024 |
| 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="0" Months="9" 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
|
Detailed clinical history was taken, and clinical examination was performed for all the enrolled patients. Following investigations was performed for all the patients at the time of admission: complete blood count (CBC), liver function test (LFT), renal function test (RFT), chest X-ray, ultrasound abdomen, fluid intake, and urine output measurement, urine routine examination, urine and blood culture and sensitivity, and arterial blood gas analysis (ABG). Subsequent serum creatinine levels were assessed during the hospital stay. Acute Kidney Injury (AKI) was categorized as per AKI-KDIGO severity classification. The etiology of Acute Kidney Injury (AKI) was also recorded. Whenever the patient requires renal replacement therapy, ionotropic support, or ventilator support, was documented. APACHE II scores were calculated at the time of admission to ICU or on the day of acute kidney injury. Patients were followed until discharge from the hospital or occurrence of in-hospital mortality. All data was collected and recorded in a pretested semi-structured questionnaire. |