NCT07479563

Brief 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 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

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
8mo left

Started Mar 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress39%
Mar 2026Apr 2027

First Submitted

Initial submission to the registry

February 27, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 18, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

March 18, 2026

Status Verified

March 1, 2026

Enrollment Period

1 year

First QC Date

February 27, 2026

Last Update Submit

March 15, 2026

Conditions

Keywords

Modified shock index

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

    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.

Study Arms (1)

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-rayDiagnostic Test: CBC

Interventions

Smear from sputum or urine to identify the site of infection

Also known as: Sputum culture, Urine culture
assess the ability of Modified Shock Index (MSI) at Emergency Department presentation to predict in-
CBCDIAGNOSTIC_TEST

Identify the infection by sepsis markers

Also known as: CRP, ESR, Kidney function tests
assess the ability of Modified Shock Index (MSI) at Emergency Department presentation to predict in-

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

People above 18 years old presenting with sepsis

You may qualify if:

  • Age ≥ 18 years Presentation to the ED with sepsis(Suspected or confirmed infection plus Evidence of organ dysfunction) (SOFA score ≥ 2 from baseline)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Sepsis

Interventions

X-RaysKidney Function Tests

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electromagnetic RadiationElectromagnetic PhenomenaMagnetic PhenomenaPhysical PhenomenaRadiationRadiation, IonizingDiagnostic Techniques, UrologicalDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Heba M Sadek, Master

    Sohag University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Heba M Sadek, Master

CONTACT

Nayel A Zaki, Professor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident

Study Record Dates

First Submitted

February 27, 2026

First Posted

March 18, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

April 1, 2027

Last Updated

March 18, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

As the data will be reviewed by supervisor and editors