Clinical trial NCT06586346: Frequency, Predictors and Outcome of Sepsis Induced Coagulopathy in Critical Care Unit
Official title: Frequency, Predictors and Outcome of Sepsis Induced Coagulopathy in Critical Care Unit
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Coagulopathy
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with 18 years of ago or older who will be admitted to critical care unit with sepsis during period between october 2024 and october 2026 ,they will divided into two groups according to development of sepsis induced coagulopathy

Brief summary: In intensive care units , sepsis remains one of the common causes of mortality and morbidity . The average hospital length of stay for sepsis is twice as long as any other fatal condition . Furthermore, sepsis survivors are at an increased risk of death or a reduced health related quality of life even after discharge from the hospital . Sepsis induces multiple and complex derangements in many systems including the coagulation cascade. The vast majority of septic patients present with hemostatic abnormalities ranging from subclinical coagulopathy to fulminant disseminated intravascular coagulation . During the initial stages of infection coagulation operates as a natural defense mechanism attempting to confine the responsible pathogen and prevent its spread into systematic circulation. However in advanced and severe infections as in sepsis, mass inflammatory cytokine production and release into the circulation lead to significantly deranged hemostatic balance . The coagulation process is activated while anticoagulant mechanisms including fibrinolysis and anticoagulant factors are suppressed. Consequently septic patients are prone to a prothrombotic state through four main mechanisms extrinsic pathway activation, cytokine induced coagulation amplification, anticoagulant pathways suppression, and fibrinolysis impairment .

Detailed description: Sepsis is defined as a life-threatening syndrome associated with physiological, pathological and biological abnormalities caused by a dysregulated host response to infections . Globally, there are ∼48.9 million sepsis cases, leading to 11 million deaths annually .

In intensive care units , sepsis remains one of the common causes of mortality and morbidity . The average hospital length of stay for sepsis is twice as long as any other fatal condition and the in-hospital mortality remains as high as 20% . Furthermore, sepsis survivors are at an increased risk of death or a reduced health-related quality of life even after discharge from the hospital .

Sepsis induces multiple and complex derangements in many systems, including the coagulation cascade. The vast majority of septic patients present with hemostatic abnormalities, ranging from subclinical coagulopathy to fulminant disseminated intravascular coagulation (DIC) . During the initial stages of infection, coagulation operates as a natural defense mechanism, attempting to confine the responsible pathogen and prevent its spread into systematic circulation. However, in advanced and severe infections, as in sepsis, mass inflammatory cytokine production and release into the circulation lead to significantly deranged hemostatic balance . The coagulation process is activated, while anticoagulant mechanisms, including fibrinolysis and anticoagulant factors, are suppressed. Consequently, septic patients are prone to a prothrombotic state through 4 main mechanisms: extrinsic pathway activation, cytokine-induced coagulation amplification, anticoagulant pathways suppression, and fibrinolysis

Eligibility criteria: Inclusion Criteria:

* Patients with 18 years of ago or older who will be admitted to critical care unit with sepsis during period between october 2024 and october 2026.

Exclusion Criteria:

* patients under tge age of 18patients with end organ diseases
* pregnant woman
* patient with coagulation disorder
* patient using anticoagulant drugs

Primary outcomes:
measure: Assess frequency and severity of sepsis induced coagulopathy in critical care unit
timeFrame: 10/9/2024 - 1/10/2026
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Dina Ali, Dr
role: STUDY_DIRECTOR
References: