| CTRI Number |
CTRI/2021/02/031412 [Registered on: 19/02/2021] Trial Registered Prospectively |
| Last Modified On: |
17/02/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective observational |
| Study Design |
Other |
|
Public Title of Study
|
Compare the standardised mortality rate with the actual mortality rate of the severely infected patients admitted in ICU using two scoring system used in icu
(APACHE-IV and SAPS-II)
|
|
Scientific Title of Study
|
A Comparative study of actual mortality rate with standardised mortality rate calculated by APACHE-IV and SAPS-II in severe sepsis and septic shock patients: A prospective observational study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Swarnika Singh |
| Designation |
Junior Resident |
| Affiliation |
Indira Gandhi Institute of Medical Sciences,patna |
| Address |
Department of Anaesthesia, Indira Gandhi Institute of Medical Sciences, Sheikhpura, Patna, Bihar.
Patna
BIHAR
800014
India |
| Phone |
8420445989 |
| Fax |
|
| Email |
swarnika001@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
vinod kumar verma |
| Designation |
professor |
| Affiliation |
Indira Gandhi Institute of Medical Sciences,patna |
| Address |
Department of Anaesthesia, Indira Gandhi Institute of Medical Sciences, Sheikhpura, Patna, Bihar.
Patna
BIHAR
800014
India |
| Phone |
8292000111 |
| Fax |
|
| Email |
drvvinodv@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Swarnika Singh |
| Designation |
Junior Resident |
| Affiliation |
Indira Gandhi Institute of Medical Sciences,patna |
| Address |
Department of Anaesthesia, Indira Gandhi Institute of Medical Sciences, Sheikhpura, Patna, Bihar.
Patna
BIHAR
800014
India |
| Phone |
8420445989 |
| Fax |
|
| Email |
swarnika001@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indira Gandhi Institute of Medical Sciences,Patna |
|
|
Primary Sponsor
|
| Name |
Swarnika Singh |
| Address |
Department of Anaesthesia, Indira Gandhi Institute of Medical Sciences, Sheikhpura, Patna, Bihar. |
| 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 |
| Swarnika Singh |
Indira Gandhi Institute of Medical Sciences, Patna |
Department of Anaesthesiology,
Ward Block First Floor,
Patna, Bihar
Patna
BIHAR |
8420445989
swarnika001@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE,IGIMS,PATNA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A419||Sepsis, unspecified organism, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients admitted in Medical ICU meeting the diagnostic criteria for severe sepsis and septic shock during the first 24 hr of admission will be included in our study. |
|
| ExclusionCriteria |
| Details |
1. Patient/patient’s party refuse to participate,
2. Age <18 years and >70 years.
3. Patients whose duration of stay in ICU was less than 4 h.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the accuracy of the APACHE IV and SAPS II scoring system in predicting mortality rate among patients admitted with severe sepsis and septic shock in our ICU |
length of stay in ICU |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To calculate predicted mortality rate using APACHE-IV Scoring System in patients of severe sepsis and septic shock.
2. To calculate predicted mortality rate using SAPS-II Scoring System in patients of severe sepsis and septic shock.
3. To compare the Actual Length of stay in ICU with the APACHE IV predicted Length of Stay in patients of severe sepsis and septic shock.
|
0hr, 6hrs, 12hr and 24hrs from the time of admission in ICU |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
24/02/2021 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
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-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
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 - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response (Others) -
- For how long will this data be available start date provided 15-02-2021 and end date provided 14-02-2022?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Sepsis is defined as life threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis remains an important cause of ICU admission, and despite advances in antibiotics and refined supportive care, mortality due to sepsis remains leading cause of death in non-coronary ICU.There are several scoring system which have been developed to calculate and predict the mortality rate in critically ill patients. APACHE is the first scoring system used to determine the prognosis of the patient. SAPS scoring system was developed later. SAPS-II is the most widely used scoring system in European ICU. we are aiming to calculate the predicted mortality rate, with the help of two scoring systems, APACHE-IV and SAPS-II, and compare it with the actual mortality rate encountered in our ICU. |