FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
Close