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Effects of Renal Replacement Therapy With Hemoadsoption in Patients With Sepsis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04533256
Recruitment Status : Recruiting
First Posted : August 31, 2020
Last Update Posted : August 31, 2020
Sponsor:
Information provided by (Responsible Party):
Popescu Mihai, Institutul Clinic Fundeni

Brief Summary:
Hemoadsorption has been demonstrated to improve clinical and paraclinical results in critically ill patients with sepsis and septic shock. The present study investigates the effects of three consecutive sessions of hemoadsorption, performed in accordance to the local protocol for treating patients with sepsis, on organ failure, severity scores and 30-days mortality. Paraclinical results and severity scores were obtained before and after the three consecutive sessions.

Condition or disease Intervention/treatment
Sepsis Procedure: CytoSorb

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 28 Days
Official Title: Effects of Renal Replacement Therapy With Hemoadsoption in Patients With Liver Failure
Actual Study Start Date : February 10, 2016
Estimated Primary Completion Date : December 30, 2021
Estimated Study Completion Date : December 30, 2021

Resource links provided by the National Library of Medicine



Intervention Details:
  • Procedure: CytoSorb
    three consecutive sessions of hemoadsorption in patients with sepsis


Primary Outcome Measures :
  1. 28-days mortality [ Time Frame: 28 days after ICU admission ]
    28-days mortality


Secondary Outcome Measures :
  1. severity score [ Time Frame: 3 days ]
    dynamics of SOFA score (Sequential Organ Failure Assessment) calculated as the mathematical difference in post-therapy SOFA score and pre-therapy SOFA score



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with sepsis or septic shock who require hemoadsorption in accordance with local guidelines. The decision of hemoadsorption is made by the attending physician prior to study inclusion.
Criteria

Inclusion Criteria:

  • patients with sepsis or septic shock who require hemoadsorption in accordance with local guidelines

Exclusion Criteria:

  • unsigned informed consent
  • duration of therapy under 12 hours
  • death before the three consecutive sessions

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04533256


Contacts
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Contact: Dana Tomescu, Prof +40722300288 danatomescu@gmail.com
Contact: Mihai Popescu, Assoc Prof +40751075995 mihai.popescu@umfcd.ro

Locations
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Romania
Fundeni Clinical Institute Recruiting
Bucharest, Romania, 022328
Contact: Dana Tomescu         
Sponsors and Collaborators
Institutul Clinic Fundeni
Investigators
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Study Chair: Dana Tomescu, Prof Fundeni Clinical Institute
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Responsible Party: Popescu Mihai, clinical professor, Institutul Clinic Fundeni
ClinicalTrials.gov Identifier: NCT04533256    
Other Study ID Numbers: Cyto-Sepsis
First Posted: August 31, 2020    Key Record Dates
Last Update Posted: August 31, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Keywords provided by Popescu Mihai, Institutul Clinic Fundeni:
organ failure
renal replacement therapy
hemoadsorption
Additional relevant MeSH terms:
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Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes