Clinical trial NCT05088109: Shock Indices Use for Early Mortality From Septic Shock
Official title: The Use of Shock Indices in Adults as Bedside Clinical Predictors for Early Death From Sepsis. A Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Septic Shock
Morality
Keywords: sepsis
early mortality
shock indices
diastolic shock index
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-10-21
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with septic shock according to the Third International Consensus Definitions for Sepsis and Septic Shock, which states septic shock as the combination of suspected infection accompanying life-threatening organ dysfunction, the requirement of vasopressor therapy to elevate MAP ≥65 mmHg and lactate \> 2 mmol/L despite adequate fluid resuscitation.

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


Eligibility criteria: 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.

Primary outcomes:
measure: Early ICU mortality from septic shock
timeFrame: 3 days from admission by septic shock
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University hospitals
state: Manial
Study officials:
References:
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.
citation: 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: 10.1097/00003246-200107000-00002.