Shock Indices Use for Early Mortality From Septic Shock

Recruiting

• Conditions: Morality; Septic Shock
• Interventions: Diagnostic Test: early mortality prediction using septic shock indices

• Registration Number: NCT05088109
• Lead Sponsor: Cairo University

Brief Summary

Background and Rationale:

Sepsis is a universal healthcare problem with a high incidence and mortality. Improvement in early sepsis recognition and management has reduced the 28 day- and in-hospital mortality in the last two decades. Mortality rates from sepsis ranges from 20% to 30% of which one-third occurs within 3 days of ICU admission.

Identifying patients with sepsis or septic shock who are at increased risk of early death can direct the priority of care for these patients and assist in predicting who is most likely to benefit from higher levels of care. In addition, this can encourage for direct future clinical trials to investigate new therapeutic interventions. Despite the large body of research on biomarkers (e.g. Serum lactate, interlukins) and clinical prediction tools (e.g. mSOFA score, APACHE II) for rapid risk stratification and in-hospital mortality of septic patients, the early identification of patients at increased risk for clinical deterioration remains challenging and the data on predictors of early death in septic patients remains deficient.

Persistently low MAP or DAP have been related to worse outcomes in septic shock, this was aggravated by the new-onset prolonged sinus tachycardia which occur as a result of sympathetic activity. This associated tachycardia has been linked to increased major cardiovascular events, prolonged length of stay and higher mortality rates The recent study by Ospina-Tascón et al. presented a novel index, the "diastolic shock index" (DSI), defined as the ratio of heart rate (HR) and diastolic arterial pressure (DAP). They studied the diastolic shock index relation to clinical outcomes in patients with septic shock. In their study, this index represented a very early identifier of patients at high risk of death within 28 days and 90 days after admission, while isolated DAP or HR values did not clearly identify such risk.

A few previous studies focused on the comparison between shock indices for prediction of sepsis outcomes and their results had a preference for DSI and MSI over SI.In this study we defined early mortality as that will occur within 3 days from admission or start of septic shock. This definition was based on previous works performed in patients with septic shock, for whom trends in organ failures during the first 3 days in the ICU were found accurate predictors of outcome .

However, almost no study focused on the ability of the diastolic shock index to predict early ICU mortality from sepsis within 72 hours from admission. So, this study aims to fill this gap in the literature.

Objectives : to investigate the ability of the diastolic shock index to predict early ICU mortality from sepsis within 72 hours from admission

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-08
• Study First Submitted QC: 2021-10-20
• Study First Posted: 2021-10-21
• Study Start: 2021-10-24
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-10
• Last Update Posted: 2023-01-11
• Primary Completion: 2023-02
• Study Completion: 2023-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

• adult patients (>18 years) with septic shock

Exclusion Criteria

• Age < 18 years
• arrythmia
• History of ischemic heart disease
• cardiomyopathy
• pregnant women
• liver cirrhosis (Child B or C)
• renal impairment
• shock other than septic shock.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SI	early mortality prediction using septic shock indices	adult patients with septic shock will be enrolled,At the time of admission (before the start of vasopressors), age of patients, source of sepsis, baseline systolic (SBP), diastolic (DBP), mean blood pressure (MAP), heart rate (HR), shock index (SI), adjusted shock index (ASI), modified shock index (MSI), diastolic shock index (DSI), baseline lactate, ABG, capillary refill time and body temperature will be recorded. Subsequent recordings will be at 0 (before starting vasopressors), 1, 2, 4, 8, and 12, 24, 48, 72 hours for all parameters except for lactate and ABG will be every 12 hours. SOFA scores, APACHE II, GCS, Charlson Comorbidity Index, will be recorded at admission; and mean total vasopressor dose, urine output will be recorded daily. Cause of death will be documented. All readings will continue for 72 after admission.

Primary Outcome Measures

Name	Time	Method
Early ICU mortality from septic shock	3 days from admission by septic shock	The ability of DSI to predict early ICU mortality

Trial Locations

Locations (1)

Cairo University hospitals; 🇪🇬 Cairo, Manial, Egypt