Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sepsis
- What is being tested?
- Chest x-ray and CBC
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2026to 1 Apr 2027
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: People above 18 years old presenting with sepsis
Who may be able to join
- Age ≥ 18 years Presentation to the ED with sepsis(Suspected or confirmed infection plus Evidence of organ dysfunction) (SOFA score ≥ 2 from baseline)
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
Read the 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
- Conditions
- Sepsis
- Being tested
- Chest x-ray, CBC
- Keywords
- Modified shock index
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chest x-rayOther
Also called Sputum culture, Urine culture
Smear from sputum or urine to identify the site of infection
CBCDiagnostic test
Also called CRP, ESR, Kidney function tests
Identify the infection by sepsis markers
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Chest x-ray; Diagnostic Test: CBC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Shock Index in patients with sepsis presenting 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.
Measured: At baseline (upon presentation to the Emergency Department)
Secondary outcomes (1)
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
- To determine the association between the Modified Shock Index measured at Emergency Department presentation and the need for Intensive Care Unit (ICU) admission.
- To evaluate the relationship between the Modified Shock Index measured at Emergency Department presentation and the requirement for vasopressor support.
- 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study start1 Mar 2026 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heba Mohamed Sadek, Sohag University
- Investigators
- Heba M Sadek, Master, Principal investigator, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07479563
- Sponsor's protocol ID
- Soh-Med-26-2-14MS
- Acronym
- MSI
- Status last verified
- Mar 2026
- First submitted
- 27 Feb 2026
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: As the data will be reviewed by supervisor and editors
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of Modified Shock Index in Patients With Sepsis Presenting to the Emergency Department
- ClinicalTrials.gov ID
- NCT07479563
- Acronym / sponsor ID
- MSI / Soh-Med-26-2-14MS
- Conditions
- Sepsis
- Keywords
- Modified shock index
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 18 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| assess the ability of Modified Shock Index (MSI) at Emergency Department presentation to predict in- | – | Other: Chest x-ray, Diagnostic Test: CBCevaluate the association between MSI and: * Intensive care unit (ICU) admission * Need for vasopressor support * Need for mechanical ventilation * Length of hospital stay |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People above 18 years old presenting with sepsis
Key inclusion criteria (1 listed)
- Age ≥ 18 years Presentation to the ED with sepsis(Suspected or confirmed infection plus Evidence of organ dysfunction) (SOFA score ≥ 2 from baseline)
Key exclusion criteria (5 listed)
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chest x-rayAlso: Sputum culture, Urine cultureSmear from sputum or urine to identify the site of infection | Other | assess the ability of Modified Shock Index (MSI) at Emergency Department presentation to predict in- |
| CBCAlso: CRP, ESR, Kidney function testsIdentify the infection by sepsis markers | Diagnostic test | assess the ability of Modified Shock Index (MSI) at Emergency Department presentation to predict in- |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Individual participant dataSharing planned: No. As the data will be reviewed by supervisor and editors
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Heba M Sadek, Master principal investigator
Sohag University
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis, run by Sohag University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Heba M Sadek, Master (01022943631 ext. 020, heba05988@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Shock Index in patients with sepsis presenting to the Emergency Department (time frame: At baseline (upon presentation to the Emergency Department)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.