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NCT Number: NCT06586346

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

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 .

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

About this study

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

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Assess frequency and severity of sepsis induced coagulopathy in critical care unit

    Time frame: 10/9/2024 - 1/10/2026

    Assess frequency and severity of sepsis induced coagulopathy in critical care unit

Study contacts

Contact information is provided by the study sponsor or research team.

Amira Ahmed

CONTACT

[email protected]

+201061223591

Mahmoud Ali, Pro

CONTACT

[email protected]

01006901937

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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