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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Cytokine Hemadsorption Therapy in Critically Ill Patients Who Have no Microbiological Findings and Develop Vasoplegic Shock
• Intervention / Treatment: Procedure: cytokine hemadsorption therapy

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

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

Study Locations

• Turkey
  • Şişli
    • İstanbul, Şişli, Turkey, 34384
      • Prof. Dr. Cemil Taşcıoğlu City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Thirty patients who met the inclusion criteria were included in the study.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
patients with vasoplegic shock; Application of cytokine hemadsorption therapy in patients with vasoplegic shock without microbiological findings	Procedure: cytokine hemadsorption therapy; Observation of cytokine hemadsorption therapy in critically ill patients who have no microbiological findings and develop vasoplegic shock.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Hakan Küçükkepeci

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Estimated): November 1, 2023
• Study Completion (Estimated): February 1, 2024

Study Registration Dates

• First Submitted: August 2, 2023
• First Submitted That Met QC Criteria: August 2, 2023
• First Posted (Actual): August 9, 2023

Study Record Updates

• Last Update Posted (Actual): August 9, 2023
• Last Update Submitted That Met QC Criteria: August 2, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: vasoplegic shock, cytokine hemadsorption, hemodynamics, mortality, cytokine storm
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: 652779