Ignite Creation Date:
2024-05-06 @ 4:46 PM
Last Modification Date:
2024-10-26 @ 2:16 PM
Study NCT ID:
NCT05088109
Status:
RECRUITING
Last Update Posted:
2023-01-11
First Post:
2021-10-08
Brief Title:
Shock Indices Use for Early Mortality From Septic Shock
Sponsor:
Cairo University
Organization:
Cairo University
Study Overview
Official Title:
The Use of Shock Indices in Adults as Bedside Clinical Predictors for Early Death From Sepsis A Prospective Observational Study
Status:
RECRUITING
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 eg Serum lactate interlukins and clinical prediction tools eg 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 SIIn 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
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 eg Serum lactate interlukins and clinical prediction tools eg 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 SIIn 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None