- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07479563
Modified Shock Index (MSI)
March 15, 2026 updated by: Heba Mohamed Sadek, Sohag University
Prognostic Value of Modified Shock Index in Patients With Sepsis Presenting to the Emergency Department
The Emergence of Modified Shock Index (MSI) To further enhance the assessment of hemodynamic stability, the modified shock index (MSI) was developed.
The MSI is defined as the ratio of heart rate to mean arterial pressure (MAP) This index takes into account the effect of diastolic blood pressure by replacing SBP with MAP in the calculation .
The modified shock index has proven to be a superior predictor of mortality compared to traditional SI .
It outperforms heart rate, systolic blood pressure, diastolic blood pressure, and SI as individual predictors
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
Sepsis is defined as a "life-threatening organ dysfunction due to a dysregulated host response to infection".
Despite high treatment expense, sepsis is often fatal .
Many a times, Sepsis is diagnosed late, and proper treatment is delayed.
When Sepsis is identified early in emergency department (ED) and aggressive therapy is initiated early, the mortality and morbidity rates can be significantly reduced because most cases of sepsis present in the ED and in the wards rather than the intensive care unit (ICU) Septic shock is a subset of sepsis characterized by persistent circulatory, cellular, and metabolic abnormalities associated with a higher risk of mortality,Clinically (Sepsis-3 definition) :- Sepsis with hypotension requiring vasopressors to maintain/ MAP ≥ 65 mmHg/AND serum lactate > 2 mmol/L/ Despite adequate fluid resuscitation The shock index (SI) is a simple and reliable formula used to evaluate the physiological response in cardiovascular performance prior to systemic hypotension.
It is calculated by dividing the heart rate by the systolic blood pressure(SBP) This ratio was first introduced by Allgower and Buri in 1967 as an inexpensive method to assess the degree of hypovolemia in hemorrhagic and infectious shock The non-invasive nature of this measurement makes it valuable in providing consistent hemodynamic data.
SI serves as a crucial metric for determining the level of tissue perfusion Moreover, it enables the assessment of the severity of hypovolemic shock The Emergence of Modified Shock Index (MSI) To further enhance the assessment of hemodynamic stability, the modified shock index (MSI) was developed.
The MSI is defined as the ratio of heart rate to mean arterial pressure (MAP) This index takes into account the effect of diastolic blood pressure by replacing SBP with MAP in the calculation .
The modified shock index has proven to be a superior predictor of mortality compared to traditional SI .
It outperforms heart rate, systolic blood pressure, diastolic blood pressure, and SI as individual predictors
Study Type
Observational
Enrollment (Estimated)
70
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Heba M Sadek, Master
- Phone Number: 020 01022943631
- Email: heba05988@gmail.com
Study Contact Backup
- Name: Nayel A Zaki, Professor
- Phone Number: 020 010 17606718
- Email: heba05988@gmail.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
People above 18 years old presenting with sepsis
Description
Inclusion Criteria:
Age ≥ 18 years Presentation to the ED with sepsis(Suspected or confirmed infection plus Evidence of organ dysfunction) (SOFA score ≥ 2 from baseline)
Exclusion Criteria:
Pregnancy
- * poly traumatized patients
- * Cardiac arrest on arrival
- * Patients with significant cardiac arrhythmia including atrial fibrillation with rapid ventricular response, or pacemaker-dependent rhythms
- * Patients transferred from another hospital after initial resuscitation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
assess the ability of Modified Shock Index (MSI) at Emergency Department presentation to predict in-
evaluate the association between MSI and:
|
Smear from sputum or urine to identify the site of infection
Other Names:
Identify the infection by sepsis markers
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Modified Shock Index in patients with sepsis presenting to the Emergency Department
Time Frame: At baseline (upon presentation to the Emergency Department)
|
To assess the Modified Shock Index (MSI), calculated as the ratio of heart rate (beats per minute) to mean arterial pressure (mmHg), in adult patients presenting with sepsis to the Emergency Department, and evaluate its prognostic value.
|
At baseline (upon presentation to the Emergency Department)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
1. Association between Modified Shock Index and ICU admission 2. Association between Modified Shock Index and vasopressor requirement 3-Association between MSI and need for mechanical ventilation 4_Association between MSI and length of hospital stay
Time Frame: 1_Within 24 hours of Emergency Department presentation. 2_During the first 24 hours of hospital admission. 3_During the first 24 hours of hospital admission. 4_From hospital admission until hospital discharge.
|
4_To evaluate the relationship between the Modified Shock Index measured at Emergency Department presentation and the total duration of hospital stay. |
1_Within 24 hours of Emergency Department presentation. 2_During the first 24 hours of hospital admission. 3_During the first 24 hours of hospital admission. 4_From hospital admission until hospital discharge.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Heba M Sadek, Master, Sohag University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
March 1, 2026
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
April 1, 2027
Study Registration Dates
First Submitted
February 27, 2026
First Submitted That Met QC Criteria
March 15, 2026
First Posted (Actual)
March 18, 2026
Study Record Updates
Last Update Posted (Actual)
March 18, 2026
Last Update Submitted That Met QC Criteria
March 15, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Infections
- Systemic Inflammatory Response Syndrome
- Inflammation
- Pathological Conditions, Signs and Symptoms
- Sepsis
- Diagnostic Techniques and Procedures
- Diagnosis
- Physical Phenomena
- Electromagnetic Phenomena
- Magnetic Phenomena
- Electromagnetic Radiation
- Radiation
- Radiation, Ionizing
- Diagnostic Techniques, Urological
- X-Rays
- Kidney Function Tests
Other Study ID Numbers
- Soh-Med-26-2-14MS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
As the data will be reviewed by supervisor and editors
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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