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Not yet recruiting NCT07479563

Modified Shock Index

Observational Sepsis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Chest x-ray, CBC.
Who it may be relevant to
Registry conditions: Sepsis. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Prognostic Value of Modified Shock Index in Patients With Sepsis Presenting to the Emergency Department

Overview

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

Interventions

  • Other Chest x-ray
    Smear from sputum or urine to identify the site of infection
  • Diagnostic test CBC
    Identify the infection by sepsis markers

Primary outcome measures

  • Modified Shock Index in patients with sepsis presenting to the Emergency Department [Time frame: At baseline (upon presentation to the Emergency Department)]
Secondary outcome measures (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 [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.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07479563 · Soh-Med-26-2-14MS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗