Coagulation Disturbances in COVID-19 Septic Patients

NCT05496816 | Completed

• 1 other identifier: CAC
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Coagulation Disorder; COVID 19 Associated Coagulopathy; Sepsis; Septic Shock

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Sepsis

Diagnostic Test: CAC in septic patients

Septic shock

Diagnostic Test: CAC in septic patients

Interventions

CAC in septic patients DIAGNOSTIC_TEST

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.

Sepsis; Septic shock

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cantonal Hospital Zenica: lead

Study Sites (1)

Cantonal Hospital

Zenica, 72000, Bosnia and Herzegovina

Location

MeSH Terms

Conditions

Hemostatic Disorders; Sepsis; Shock, Septic

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist

Study Record Dates

• First Submitted: August 7, 2022
• First Posted: August 11, 2022
• Study Start: January 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: August 11, 2022

Record last verified: 2022-08

Locations

BO (1)