Shock Indices Use for Early Mortality From Septic Shock

Septic Shock Clinical Trial

Official title:

The Use of Shock Indices in Adults as Bedside Clinical Predictors for Early Death From Sepsis. A Prospective Observational Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05088109
• Other study ID #: N-27-2021/RS
• Status: Recruiting
• Start date: October 24, 2021
• Est. completion date: February 2023

Study information

• Verified date: January 2023
• Source: Cairo University
• Contact: Sherif Abdullah, M.D.
• Phone: 01002013497
• Email: dr.sherif213[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 43
• Est. completion date: February 2023
• Est. primary completion date: February 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Morality
• Septic Shock
• Shock
• Shock, Septic

Intervention

Diagnostic Test:
• early mortality prediction using septic shock indices
The Shock Index (SI) is the ratio of pulse rate to systolic blood pressure calculated by dividing pulse rate (beat/min) by systolic blood pressure (mm Hg). The adjusted shock index (ASI) is SI calculated after adjusting the heart rate according to body temperature that 10 beats will be added to the heart rate for every 1.0 °C rise in the body temperature above 37.0 °C. The modified shock index (MSI) is a ratio of heart rate to mean blood pressure (MAP). The DSI is a ratio of heart rate to diastolic blood pressure (DAP).

Locations

Country	Name	City	State
Egypt	Cairo University hospitals	Cairo	Manial

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

Angus DC, Linde-Zwirble WT, Lidicker J, Clermont G, Carcillo J, Pinsky MR. Epidemiology of severe sepsis in the United States: analysis of incidence, outcome, and associated costs of care. Crit Care Med. 2001 Jul;29(7):1303-10. doi: 10.1097/00003246-20010 — View Citation

Ospina-Tascon GA, Teboul JL, Hernandez G, Alvarez I, Sanchez-Ortiz AI, Calderon-Tapia LE, Manzano-Nunez R, Quinones E, Madrinan-Navia HJ, Ruiz JE, Aldana JL, Bakker J. Diastolic shock index and clinical outcomes in patients with septic shock. Ann Intensive Care. 2020 Apr 16;10(1):41. doi: 10.1186/s13613-020-00658-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Early ICU mortality from septic shock	The ability of DSI to predict early ICU mortality	3 days from admission by septic shock