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Not Yet RecruitingNCT06586346

Frequency, Predictors and Outcome of Sepsis Induced Coagulopathy in Critical Care Unit

Status
Not Yet Recruiting
Phase
Study type
Observational
Enrollment
100 (estimated)
Sponsor
Assiut University · Academic / Other
Sex
All
Age
18 Years – 75 Years
Healthy volunteers

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

Conditions

Timeline

Start date
2024-09-10
Primary completion
2026-08-01
Completion
2026-08-01
First posted
2024-09-19
Last updated
2024-09-19

Source: ClinicalTrials.gov record NCT06586346. Inclusion in this directory is not an endorsement.

Frequency, Predictors and Outcome of Sepsis Induced Coagulopathy in Critical Care Unit (NCT06586346) · Clinical Trials Directory