Shock Indices Use for Early Mortality From Septic Shock

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

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

Study Overview

• Status: Recruiting
• Conditions: Septic Shock; Morality
• Intervention / Treatment: Diagnostic test: early mortality prediction using septic shock indices

• Study Type: Observational
• Enrollment (Anticipated): 43

Contacts and Locations

• Study Contact: Name: Sherif Abdullah, M.D.; Phone Number: 02 01002013497; Email: dr.sherif213@yahoo.com
• Study Contact Backup: Name: Ayman Hussam, M.D.; Phone Number: 02 01004389020; Email: aymanhussam@yahoo.com

Study Locations

• Egypt
  • Manial
    • Cairo, Manial, Egypt, 12511
      • Recruiting
      • Cairo University Hospitals
      • Contact: Ayman Hussam, M.D.; Phone Number: 01004389020; Email: Ahhussam@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

SI; 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.

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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Early ICU mortality from septic shock	The ability of DSI to predict early ICU mortality	3 days from admission by septic shock

Collaborators and Investigators

• Sponsor: Cairo University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 24, 2021
• Primary Completion (Anticipated): February 1, 2023
• Study Completion (Anticipated): February 1, 2023

Study Registration Dates

• First Submitted: October 8, 2021
• First Submitted That Met QC Criteria: October 20, 2021
• First Posted (Actual): October 21, 2021

Study Record Updates

• Last Update Posted (Estimate): January 11, 2023
• Last Update Submitted That Met QC Criteria: January 10, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: sepsis; early mortality; shock indices; diastolic shock index
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Shock, Septic; Shock
• Other Study ID Numbers: N-27-2021/RS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: not to share

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No