Coagulation Disturbances in COVID-19 Septic Patients

Completed

• Conditions: Septic Shock; COVID 19 Associated Coagulopathy; Sepsis; Coagulation Disorder

• Registration Number: NCT05496816
• Lead Sponsor: Cantonal Hospital Zenica

Brief Summary

Objective of this study was to determine the relationship between CAC and septic condition in COVID-19 critically ill patients. Data including age, sex, comorbidities, quick Sequential Organ Failure Assessment (qSOFA) score, vasopressors requirement, laboratory findings: platelets, neutrophils, lymphocytes, procalcitonin (PCT), C-reactive protein (CRP), fibrinogen, D-dimer, sepsis-induced coagulopathy (SIC) and disseminated intravascular coagulation (DIC) score were recorded on the day of admission and on the day of starting of invasive mechanical ventilation. Primary outcome was to establish CAC with sepsis; secondary outcome measure was incidence of CAC in sepsis and septic shock in COVID-19 critically ill patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-01
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Status Verified: 2022-08
• Study First Submitted: 2022-08-07
• Study First Submitted QC: 2022-08-10
• Last Update Submitted: 2022-08-10
• Study First Posted: 2022-08-11
• Last Update Posted: 2022-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• all adult critically ill patients tested positive for reverse transcriptase polymerase chain reaction (RT-PCR) of nasopharyngeal swabs to coronavirus 2 (SARS-CoV-2)
• patienets admitted to the ICU and presented with acute hypoxemic respirator failure

Exclusion Criteria

• patients younger than 18,
• immunodeficient patients,
• patients with a history of malignancies,
• patients who developed septic state before admission,
• patients with a history of previous coagulopathy, liver and platelet disease.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of patients with coagulation disorder	1 year	Laboratory analysis included analysis of platelets, neutrophils, lymphocytes, PCT, CRP, fibrinogen, D-dimer on the day of admission and on the day of initation of invasive mechanical ventilation or on the day of discharge.

Trial Locations

Locations (1)

Cantonal Hospital; 🇧🇦 Zenica, Bosnia and Herzegovina