EFFECTS OF EXTRACORPOREAL CYTOKINE ELIMINATION ON HEMODYNAMIA AND MORTALITY IN CRITICAL PATIENTS

Study Overview
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Brief Summary
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Observation of the effects of cytokine adsorbent hemadsorption therapy on hemodynamics and mortality in critically ill patients who developed vasoplegic shock due to hyperinflammation without microbiological findings in the intensive care unit.

Detailed Description
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Observation of the effects of cytokine adsorbent hemadsorption therapy on hemodynamics and mortality in critically ill patients who developed vasoplegic shock due to hyperinflammation without microbiological findings and met the inclusion criteria in the Intensive Care Unit between 01.08.2023 and 01.02.2024

Official Title
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EFFECTS OF EXTRACORPOREAL CYTOKINE ELIMINATION ON HEMODYNAMIA AND MORTALITY IN CRITICAL PATIENTS

Conditions
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Cytokine Hemadsorption Therapy in Critically Ill Patients Who Have no Microbiological Findings and Develop Vasoplegic Shock

Intervention / Treatment
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* Procedure: cytokine hemadsorption therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: C-reactive protein (CRP) ≥ 100 mg/l Procalcitonin (PCT) < 2 ng/l Patients aged 18-80 years who were treated with cytokine adsorption due to vasoplegic shock Exclusion Criteria: Patients under 18 years of age Patients with suspected or proven bacterial cause of vasoplegic shock. Those who did not approve to participate in the study Patients without vasoplegic shock Patients with CRP < 100 mg/l, PCT ≥ 2 μg/L

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients with vasoplegic shock<br>Application of cytokine hemadsorption therapy in patients with vasoplegic shock without microbiological findings | Procedure: cytokine hemadsorption therapy<br>* Observation of cytokine hemadsorption therapy in critically ill patients who have no microbiological findings and develop vasoplegic shock.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The time to resolution of vasoplegic shock within days. |  | From enrollment to the end of treatment at 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 7-day mortality |  | 7 days | 
| mortality until discharge from hospital |  | From enrollment to the end of treatment at 12 weeks | 
| Interleukin 1 beta level on day 1 |  | one day | 
| Interleukin 10 level on day 1 |  | one day | 
| Interleukin 6 level on day 1 |  | one day | 
| TNF - α level on day 1 |  | one day | 
| Interleukin 1 beta level on day 3 |  | 3 days | 
| Interleukin 10 level on day 3 |  | 3 days | 
| Interleukin 6 level on day 3 |  | 3 days | 
| TNF - α level on day 3 |  | 3 days | 
| mechanical ventilation need and duration |  | From enrollment to the end of treatment at 12 weeks | 
| duration of treatment in the intensive care unit |  | From enrollment to the end of treatment at 12 weeks | 
| dose of catecholamine |  | From enrollment to the end of treatment at 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vasoplegic shock, cytokine hemadsorption, hemodynamics, mortality, cytokine storm