| CTRI Number |
CTRI/2025/07/090571 [Registered on: 09/07/2025] Trial Registered Prospectively |
| Last Modified On: |
10/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective observational study |
| Study Design |
Other |
|
Public Title of Study
|
A Study to See the Early Treatment and Bedside Ultrasound Help Patients with blood infection and complication of blood infection in the Emergency department of a Hospital in Manipur |
|
Scientific Title of Study
|
A prospective observational Study evaluating the
impact of combining the One-Hour Sepsis Bundle and Point-of-Care Ultrasound (POCUS) in Sepsis and Septic Shock Patients presenting to Emergency Department in a Tertiary Care Hospital, in Manipur |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MUHAMMED SHADIL K E |
| Designation |
DNB EMERGENCY MEDICINE TRAINEE |
| Affiliation |
Shija Hospitals and Research Institute |
| Address |
Emergency Medicine Department,Emergency Room,Shija Hospitals and Research Institute
Langol
Imphal West
MANIPUR
795004
India |
| Phone |
7560871466 |
| Fax |
|
| Email |
shadilke1234@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sweta Khuraijam |
| Designation |
Consultant, Emergency Medicine |
| Affiliation |
Shija Hospitals and Research Institute |
| Address |
Emergency Medicine Department,Emergency Room,Shija Hospitals and Research Institute
Langol
Imphal West
MANIPUR
795004
India |
| Phone |
7982576807 |
| Fax |
|
| Email |
khuraijam.sweta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
MUHAMMED SHADIL K E |
| Designation |
DNB EMERGENCY MEDICINE TRAINEE |
| Affiliation |
Shija Hospitals and Research Institute |
| Address |
Emergency Medicine Department,Emergency Room,Shija Hospitals and Research Institute
Langol
Imphal West
MANIPUR
795004
India |
| Phone |
7560871466 |
| Fax |
|
| Email |
shadilke1234@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shija Hospitals and Research Institute Langol,Manipur,India,Pin 795004 |
|
|
Primary Sponsor
|
| Name |
MUHAMMED SHADIL K E |
| Address |
Shija Hospitals and Research Institute
Langol, Imphal -795004,manipur |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| MUHAMMED SHADIL K E |
Shija Hospitals and Research Institute |
Emergency department,Emergency medicine,Red zone area,Langol, Imphal -795004, Manipur
Imphal West
MANIPUR |
7560871466
shadilke1234@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee,SAHS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D758||Other specified diseases of bloodand blood-forming organs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients presenting to the ED with suspected sepsis or septic shock based on clinical criteria (e.g. qSOFA,NEWS2 score) |
|
| ExclusionCriteria |
| Details |
Patients (close relatives in case of unconscious patients) who refuse to give consent;Patients with age less than18 years and more than 65 years;Pregnant women;Known terminal illness with a prognosis of less than 6 months;Contraindications to ultrasound (e.g., extensive body surface area edema);Patients with spinal cord injury. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the impact of combining the 1-hour sepsis bundle with POCUS on clinical outcomes (change in qSOFA, NEWS2, Lactate and Blood Pressure (MAP) ) in patients with sepsis or septic shock presenting to the Emergency Department. |
Period of one and half
years from june 2025 to December 2026. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) To assess the time to intervention (antibiotics, fluids, vasopressors) in sepsis and septic shock patients.
2) To evaluate the accuracy and utility of POCUS in assessing volume status, cardiac function, and identifying potential sources of infection in septic patients.
3) To evaluate the effectiveness of POCUS in the prevention of fluid overload and to rule out differentials.
4) To evaluate change in qSOFA, NEWS2, serum lactate, and blood pressure (MAP) by combining the sepsis one-hour bundle and POCUS after one hour of identifying/ suspecting sepsis or septic shock. |
Period of one and half
years from june 2025 to December 2026. |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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)
|
16/07/2025 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Sepsis and septic shock remain leading causes of morbidity and mortality worldwide. Early identification and prompt treatment are critical to improving outcomes.This thesis aims to evaluate the impact of combining the 1-hour sepsis bundle with POCUS in the management of sepsis and septic shock patients presenting to Emergency Department in a tertiary care hospital, assessing its effects on patient outcomes, time to intervention, and clinical decision-making The study will involve Patients presenting to the ED with suspected sepsis or septic shock based on clinical criteria (e.g. qSOFA,NEWS2 score).It is anticipated that the use of POCUS in conjunction with the 1-hour sepsis bundle will result in Quicker identification and treatment of sepsis, Improved fluid resuscitation and cardiac optimization, More efficient management of septic shock.Data will be analyzed using appropriate statistical methods, adjusting for confounders and handling missing data with multiple imputation. This study aims to evaluate the impact of combining the 1-hour sepsis bundle with POCUS in the management of sepsis and septic shock patients presenting to Emergency Department and results of the study may ultimately contribute to evidence-based guidelines in the field of Emergency Medicine.
|