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

NCT06586346 | Not Yet Recruiting

• 1 other identifier: Sepsis induced coagulopathy
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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 .

Conditions

Coagulopathy

Outcome Measures

Primary Outcomes (1)

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

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

  10/9/2024 - 1/10/2026

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Hemostatic Disorders

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Dina Ali, Dr

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

Amira Ahmed

CONTACT

+201061223591; amira.16266014@med.aun.edu.eg

Mahmoud Ali, Pro

CONTACT

01006901937; mahmoudashri@med.aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: September 4, 2024
• First Posted: September 19, 2024
• Study Start: September 10, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share