Skip to main content
OpenTrials
Completed

NCT Number: NCT06415006

Can Shock Indices Be Prognostic Indicators in Sepsis/Septic Shock?

We evaluated the ability of shock indices and hemodynamic parameters to predict 28-day ICU mortality.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Shock, Septic Hemodynamic Instability Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Shock Systemic Inflammatory Response Syndrome

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Basaksehir Cam Sakura City Hospital

Istanbul, Turkey (Türkiye)

About this study

Shock indices and hemodynamic parameters are significant determinants of mortality in adult ICU patients. This study aimed to evaluate the potential of four known shock indices Shock Index (SI), Age-adjusted Shock Index (aSI), Diastolic Shock Index (dSI), and hemodynamic parameters including Heart Rate (HR), Systolic Arterial Blood Pressure (ABPsys), Diastolic Arterial Blood Pressure (ABPdias), and Mean Arterial Blood Pressure (ABPmean) in predicting 28-day ICU mortality in patients diagnosed with sepsis and septic shock.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with a preliminary diagnosis of sepsis/septic shock in the intensive care unit
  • Adult patients aged between 18 and 80 years

Exclusion criteria

  • Patients under 18 years old
  • Pregnant patients
  • Patients suspected of having COVID-19 pneumonia
  • Patients with incomplete data
  • Patients for whom outcome information is unavailable due to referral to an external center
  • Patients with confirmed COVID-19, validated by thoracic computed tomography images and nasal swab PCR results
  • Patients discharged from the intensive care unit within 24 hours

Treatment and study plan

Measurement of hemodynamic parameters.

Procedure

The measurement and recording of Heart Rate (HR), Systolic Arterial Blood Pressure (ABPsys), Diastolic Arterial Blood Pressure (ABPdias), Mean Arterial Blood Pressure (ABPmean), and age parameters.

Primary outcomes

  1. Shock Index (SI)

    Time frame: During the first 7 hours in the ICU

    The predictive power of the Shock Index (SI) parameter for 28-day mortality in sepsis patients treated in the intensive care unit.

  2. Age-adjusted Shock Index (aSI)

    Time frame: During the first 7 hours in the ICU

    The predictive power of the Age-adjusted Shock Index (aSI) parameter for 28-day mortality in sepsis patients treated in the intensive care unit.

  3. Diastolic Shock Index (dSI)

    Time frame: During the first 7 hours in the ICU

    The predictive power of the Diastolic Shock Index (dSI) parameter for 28-day mortality in sepsis patients treated in the intensive care unit.

  4. modified Shock Index (mSI)

    Time frame: During the first 7 hours in the ICU

    The predictive power of the modified Shock Index (mSI) parameter for 28-day mortality in sepsis patients treated in the intensive care unit.

Secondary outcomes

  1. Heart Rate (HR)

    Time frame: During the first 7 hours in the ICU

    The predictive power of the Heart Rate (HR) parameter for 28-day mortality in sepsis patients treated in the intensive care unit.

  2. Systolic Arterial Blood Pressure (ABPsys)

    Time frame: During the first 7 hours in the ICU

    The predictive power of the Systolic Arterial Blood Pressure (ABPsys) parameter for 28-day mortality in sepsis patients treated in the intensive care unit.

  3. Diastolic Arterial Blood Pressure (ABPdias)

    Time frame: During the first 7 hours in the ICU

    The predictive power of the Diastolic Arterial Blood Pressure (ABPdias) parameter for 28-day mortality in sepsis patients treated in the intensive care unit.

  4. Mean Arterial Blood Pressure (ABPmean)

    Time frame: During the first 7 hours in the ICU

    The predictive power of the Mean Arterial Blood Pressure (ABPmean) parameter for 28-day mortality in sepsis patients treated in the intensive care unit.

  5. Age

    Time frame: During the first 7 hours in the ICU

    The predictive power of the age for 28-day mortality in sepsis patients treated in the intensive care unit.

Sponsors and collaborators

Lead sponsor

Başakşehir Çam & Sakura City Hospital

Other Gov

Collaborators

  • SBÜ Dr. Sadi Konuk Eğitim ve Araştırma Hastanesi

Registry information

Important dates

Study start
2012
Primary completion
2023
Study completion
2024
First posted
May 16, 2024
Registry last updated
May 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.