Evaluation of the Effectiveness of Extracorporeal Methods for Removing Mediators of Systemic Inflammation

• Sponsor: Petrovsky National Research Centre of Surgery (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05182723
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 42.2
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the effectiveness and the safety of extracorporeal methods for removing mediators of systemic inflammation in patients with multiple organ dysfunction syndrome after heart and aorta surgery.

Condition or Disease	Intervention/Treatment	Phase
Renal Failure Acute; Multiple Organ Failure; Cardiovascular Diseases	Procedure: renal replacement therapy	N/A

Detailed Description

After being informed about the study and potential risk, all patients with multiple organ dysfunction syndrome after heart and aorta surgery with indications for extracorporeal removal of inflammatory mediators, giving written informed consent will be included in the study.

Patients will be randomized 1:1 ratio to 1. hemoperfusion cartridge for cytokine sorption in combination with an oXiris membrane and 2. oXiris membrane.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluation of the Effectiveness of Extracorporeal Methods for Removing Mediators of Systemic Inflammation in Patient With Multiple Organ Dysfunction Syndrome After Heart and Aortic Surgery
• Actual Study Start Date: Nov 25, 2021
• Anticipated Primary Completion Date: Nov 30, 2024
• Anticipated Study Completion Date: May 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: oXiris Monotoring of extracorporeal Method for Removing Mediators of Systemic Inflammation of oXiris will be performed for 24 hours	Procedure: renal replacement therapy; Extracorporeal Methods for Removing Mediators of Systemic Inflammation
Experimental: oXiris in combination with Jafron HA330 Extracorporeal Method for Removing Mediators of Systemic Inflammation oXiris in combination with Jafron HA330 will be performed for 4 hours. If SOFA is more or equally 4 , CRP is more than 100 ng/ml;, the IL6 value is increased by 5 or more times after 12 hours of procedure Jafron HA330 will be reconnected and performed for 4 hours. Monitoring of whole procedure will be performed for 24 hours.	Procedure: renal replacement therapy; Extracorporeal Methods for Removing Mediators of Systemic Inflammation

Outcome Measures

Primary Outcome Measures

1. CRP [12 hours from the beginning of the study]

   сhange of CRP after 12 hours from baseline value

2. CRP [24 hours from the beginning of the study]

   сhange of CRP after 24 hours from baseline value

3. CRP [24 hours from the beginning of the study]

   comparison of CRP after 12 hours with CRP after 24 hours

4. IL6 [12 hours from the beginning of the study]

   сhange of IL6 after 12 hours from baseline value

5. IL6 [24 hours from the beginning of the study]

   сhange of IL6 after 24 hours from baseline value

6. IL6 [24 hours from the beginning of the study]

   comparison of IL6 after 12 hours with IL6 after 24 hours

7. SOFA [12 hours from the beginning of the study]

   change of SOFA values after 12 hours from baseline value

8. SOFA [24 hours from the beginning of the study]

   change of SOFA values after 24 hours from baseline value

9. SOFA [24 hours from the beginning of the study]

   comparison of the SOFA value after 12 hours with the SOFA value after 24 hours

Secondary Outcome Measures

1. extracorporeal therapy [hospitalisation period, an average of 1 month]

   duration

2. time spent in intensive care unit [hospitalisation period, an average of 1 month]

   duration

3. inpatient stay time [through study completion, an average of 2 months]

   duration

4. renal function of RIFLE [through study completion, an average of 2 months]

   percentage decrease from initial level

5. lethality [through study completion, an average of 2 months]

   ratio of the number of deaths to the total number of patients

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• multiple organ dysfunction;

• SOFA equal to or more than 4;

• CRP equal to or more than 100 ng / ml;

• increase of IL6 by 5 times or more

Exclusion Criteria:

• the impossibility to use heparin ( bleeding; heparin-induced thrombocytopenia)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Petrovsky Nacional research Centre of Surgery	Moscow		Russian Federation	119991

Sponsors and Collaborators

• Petrovsky National Research Centre of Surgery

Investigators

• Study Director: Aleksandr Eremenko, MD, Petrovsky National Research Centre of Surgery
• Principal Investigator: Tatiana Marchenko, Petrovsky National Research Centre of Surgery

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Aleksandr Eremenko, Clinical Professor, Petrovsky National Research Centre of Surgery
• ClinicalTrials.gov Identifier: NCT05182723
• Other Study ID Numbers: 20211028-18
• First Posted: Jan 10, 2022
• Last Update Posted: Feb 3, 2022
• Last Verified: Jan 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Aleksandr Eremenko, Clinical Professor, Petrovsky National Research Centre of Surgery: mediators of systemic inflammation; extracorporeal methods; interleukins
• Additional relevant MeSH terms: Acute Kidney Injury; Cardiovascular Diseases; Inflammation; Multiple Organ Failure

Study Results

No Results Posted as of Feb 3, 2022