Analysis of Laboratory Markers for Severe COVID-19

NCT06460753 | Completed

• 1 other identifier: SC19MI-ARICU-1T
• Study Type: observational
• Target: 193
• Locations: 1 country
• Sites: 1

Brief Summary

The course of coronavirus infection was often severe and required hospitalization of patients in the intensive care unit. The new SARS-Cov-2 has been poor studied, so relatively reliable markers are needed to effectively monitor patients and predict complications and outcome. Taking into account the known mechanisms of pathogenesis, the biochemical markers as ferritin, procalcitonin, C-reactive protein and D-dimer were chosen for this purpose. Patients were divided according to the degree of pulmonary infiltration. We hypothesized that the markers would correlate with dynamics, complications, and outcomes.

Conditions

Coronavirus Infection COVID-19

Keywords

coronavirus infection; COVID-19; biochemical markers; forecasting; outcomes; resuscitation and intensive care

Outcome Measures

Primary Outcomes (2)

• Biochemical markers' correlation with outcomes

  In the early stages of hospitalization was found the significant inverse correlation (p \< 0.01, r -0.236) with the outcome of the stay for procalcitonin levels on the third day - larger concentrations of this marker were associated with death for the patient; on day 7 - weaker inverse correlation (p \< 0.05, r -0.246), by the end of treatment - a significant inverse correlation at p \< 0.001, r -0.393. A correlation between D-dimer and the outcome of the stay was revealed - on the 3rd day and at the end of treatment - in both cases the correlation is inverse, quite significant (p \< 0.01, r-0.237and p \< 0.001, r-0.512 respectively). Higher ferritin levels correlated with death when determined in the late period of hospitalization - inverse correlation at p \< 0.001, r-0.447.

  Laboratory markers were measured daily. For correlation analysis, control days of measurements were chosen: days 1-3-7-15.

• Markers as outcome predictors

  According to the results of ROC analysis predictively significant for mortal outcome (\*AUC values are close to 1.0, at the significance level P =0.05) were: procalcitonin level on days 3, 7 and 15, CRP level on days 7 and 15, levels of D-dimer on days 3, 7 and 15, ferritin on days 3 and 7

  Laboratory markers were measured daily. For correlation analysis, control days of measurements were chosen: days 1-3-7-15.

Secondary Outcomes (3)

• the correlation between the level of biomarkers and the degree of infiltration of lung tissue

  Laboratory markers were measured daily. For correlation analysis, control days of measurements were chosen: days 1-3-7-15.

• The level of D-dimer quite significantly negatively correlated with the duration of stay in the intensive care unit

  Laboratory markers were measured daily. For correlation analysis, control days of measurements were chosen: days 1-3-7-15.

• The inverse correlation was found for procalcitonin and the patient-bed-days in the intensive care unit

  Laboratory markers were measured daily. For correlation analysis, control days of measurements were chosen: days 1-3-7-15.

Study Arms (1)

hospitalized to ICU severe patients with coronavirus infection COVID-19

an analysis of the medical records was carried out

Diagnostic Test: CT of the chest organs, blood biochemical parameters

Interventions

CT of the chest organs, blood biochemical parameters DIAGNOSTIC_TEST

Taking into account the clinical manifestations, all patients underwent chest computed tomography (CT) to diagnose COVID-19-associated pneumonia. According to the CT results, all patients were classified into one of 4 subgroups, according to the degree of pulmonary infiltration. The following biochemical parameters were selected and used to monitor dynamics: procalcitonin (PCT), C-reactive protein (CRP), D-dimer (DD), ferritin (FRT). Biochemical markers were determined daily during the stay in the intensive care unit. The duration of observation was 15 days was selected. Information was analysed retrospectively.

hospitalized to ICU severe patients with coronavirus infection COVID-19

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients hospitalized in the intensive care unit of the Regional Clinical Hospital of Karaganda, which is the clinical base of the Karaganda Medical University.

You may qualify if:

• identified COVID-19 by nasopharyngeal material PCR, coronavirus associated lung infiltration, visualized by CT, and clinically severe condition

You may not qualify if:

• pregnancy

Sponsors & Collaborators

• Karaganda Medical University: lead

Study Sites (1)

Karaganda Medical University

Karaganda, 100008, Kazakhstan

Location

Biospecimen

Retention: NONE RETAINED

biochemical parameters: procalcitonin, C-reactive protein, D-dimer, ferritin

MeSH Terms

Conditions

Coronavirus Infections; COVID-19

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Aissulu Issabekova, MD

  Karaganda Medical University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2024
• First Posted: June 14, 2024
• Study Start: April 10, 2024
• Primary Completion: June 10, 2024
• Study Completion: June 10, 2024
• Last Updated: June 14, 2024

Record last verified: 2024-06

Locations

KA (1)