Clinical trial NCT05984407: EFFECTS OF EXTRACORPOREAL CYTOKINE ELIMINATION ON HEMODYNAMIA AND MORTALITY IN CRITICAL PATIENTS
Official title: EFFECTS OF EXTRACORPOREAL CYTOKINE ELIMINATION ON HEMODYNAMIA AND MORTALITY IN CRITICAL PATIENTS
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Cytokine Hemadsorption Therapy in Critically Ill Patients Who Have no Microbiological Findings and Develop Vasoplegic Shock
Keywords: vasoplegic shock, cytokine hemadsorption, hemodynamics, mortality, cytokine storm
Lead sponsor: Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
Sponsor class: OTHER
First posted: 2023-08-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Thirty patients who met the inclusion criteria were included in the study.

Brief summary: 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: 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

Eligibility criteria: 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

Primary outcomes:
measure: The time to resolution of vasoplegic shock within days.
timeFrame: From enrollment to the end of treatment at 12 weeks
Secondary outcomes:
measure: 7-day mortality
timeFrame: 7 days
measure: mortality until discharge from hospital
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Interleukin 1 beta level on day 1
timeFrame: one day
measure: Interleukin 10 level on day 1
timeFrame: one day
measure: Interleukin 6 level on day 1
timeFrame: one day
measure: TNF - α level on day 1
timeFrame: one day
measure: Interleukin 1 beta level on day 3
timeFrame: 3 days
measure: Interleukin 10 level on day 3
timeFrame: 3 days
measure: Interleukin 6 level on day 3
timeFrame: 3 days
measure: TNF - α level on day 3
timeFrame: 3 days
measure: mechanical ventilation need and duration
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: duration of treatment in the intensive care unit
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: dose of catecholamine
timeFrame: From enrollment to the end of treatment at 12 weeks
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Prof. Dr. Cemil Taşcıoğlu City Hospital
state: Şişli
Study officials:
References: