Coagulation Disturbances in COVID-19 Septic Patients

COVID-19 Associated Coagulopathy (CAC) in Septic Critically Ill Patients- a Retrospective Cohort Study

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.

Study Overview

• Status: Completed
• Conditions: Sepsis; Septic Shock; Coagulation Disorder; COVID 19 Associated Coagulopathy
• Intervention / Treatment: Diagnostic test: CAC in septic patients

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Bosnia and Herzegovina
  • Zenica, Bosnia and Herzegovina, 72000
    • Cantonal Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

This study was conducted in the COVID-19 Intensive Care Unit in the Department of Anesthesiology, Resuscitation and Intensive Care, Cantonal Hospital Zenica. Electronic data from 100 patients in 2021. were retrospectively analyzed after obtaining approval of the ethics committee of our hospital.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Sepsis	Diagnostic test: CAC in septic patients; Data collected included demographic parameters, comorbidities, vasopressors requirement, laboratory findings, in-hospital mortality scoring and diagnostic colagulation scores. Demographic parameters were taken on the day of admission, all other variables were taken on the day of admission to the ICU and on the day of initiation of invasive mechanical ventilation or on the day of discharge from the ICU. Demographic parameters included age and sex of the patient, followed by comorbidities which was marked with Yes or No on the day of admission in the ICU. Mortality was assessed according to the qSOFA score and vasopressor requirements on the day of admission and on the day of initation of invasive mechanical ventilation or on the day of discharge. 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.
Septic shock	Diagnostic test: CAC in septic patients; Data collected included demographic parameters, comorbidities, vasopressors requirement, laboratory findings, in-hospital mortality scoring and diagnostic colagulation scores. Demographic parameters were taken on the day of admission, all other variables were taken on the day of admission to the ICU and on the day of initiation of invasive mechanical ventilation or on the day of discharge from the ICU. Demographic parameters included age and sex of the patient, followed by comorbidities which was marked with Yes or No on the day of admission in the ICU. Mortality was assessed according to the qSOFA score and vasopressor requirements on the day of admission and on the day of initation of invasive mechanical ventilation or on the day of discharge. 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with coagulation disorder	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.	1 year

Collaborators and Investigators

• Sponsor: Cantonal Hospital Zenica

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2021
• Primary Completion (ACTUAL): December 31, 2021
• Study Completion (ACTUAL): December 31, 2021

Study Registration Dates

• First Submitted: August 7, 2022
• First Submitted That Met QC Criteria: August 10, 2022
• First Posted (ACTUAL): August 11, 2022

Study Record Updates

• Last Update Posted (ACTUAL): August 11, 2022
• Last Update Submitted That Met QC Criteria: August 10, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Hematologic Diseases; Hemorrhagic Disorders; COVID-19; Hemostatic Disorders; Blood Coagulation Disorders
• Other Study ID Numbers: CAC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No