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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
assess the ability of Modified Shock Index (MSI) at Emergency Department presentation to predict in-

evaluate the association between MSI and:

  • Intensive care unit (ICU) admission
  • Need for vasopressor support
  • Need for mechanical ventilation
  • Length of hospital stay
Other: Chest x-ray
Smear from sputum or urine to identify the site of infection
Other Names:
  • Sputum culture
  • Urine culture
Diagnostic test: CBC
Identify the infection by sepsis markers
Other Names:
  • ESR
  • CRP
  • Kidney function tests

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.
  1. To determine the association between the Modified Shock Index measured at Emergency Department presentation and the need for Intensive Care Unit (ICU) admission.
  2. To evaluate the relationship between the Modified Shock Index measured at Emergency Department presentation and the requirement for vasopressor support.
  3. To determine the association between the Modified Shock Index measured at Emergency Department presentation and the requirement for invasive mechanical ventilation.

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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sohag University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 27, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 15, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 18, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 15, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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