Clinical trial NCT06415006: Can Shock Indices Be Prognostic Indicators in Sepsis/Septic Shock?
Official title: Can Shock Indices Be Prognostic Indicators in Sepsis/Septic Shock?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Shock, Septic
Hemodynamic Instability
Lead sponsor: Başakşehir Çam & Sakura City Hospital
Sponsor class: OTHER_GOV
Collaborators: name: SBÜ Dr. Sadi Konuk Eğitim ve Araştırma Hastanesi
First posted: 2024-05-16
Enrollment: 1522
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: "1,522 patients treated for sepsis/septic shock in the Anesthesiology and Reanimation intensive care unit at Bakırköy Dr. Sadi Konuk Training and Research Hospital."

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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Shock Index (SI)
timeFrame: During the first 7 hours in the ICU
measure: Age-adjusted Shock Index (aSI)
timeFrame: During the first 7 hours in the ICU
measure: Diastolic Shock Index (dSI)
timeFrame: During the first 7 hours in the ICU
measure: modified Shock Index (mSI)
timeFrame: During the first 7 hours in the ICU
Secondary outcomes:
measure: Heart Rate (HR)
timeFrame: During the first 7 hours in the ICU
measure: Systolic Arterial Blood Pressure (ABPsys)
timeFrame: During the first 7 hours in the ICU
measure: Diastolic Arterial Blood Pressure (ABPdias)
timeFrame: During the first 7 hours in the ICU
measure: Mean Arterial Blood Pressure (ABPmean)
timeFrame: During the first 7 hours in the ICU
measure: Age
timeFrame: During the first 7 hours in the ICU
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Basaksehir Cam Sakura City Hospital
Study officials:
References:
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citation: Avci M, Doganay F. Prognostic Performance of Shock Index, Diastolic Shock Index, Age Shock Index, and Modified Shock Index in COVID-19 Pneumonia. Disaster Med Public Health Prep. 2022 May 2;17:e189. doi: 10.1017/dmp.2022.110.