Effects of Renal Replacement Therapy With Hemoadsoption in Patients With Sepsis

September 3, 2021 updated by: Popescu Mihai, Institutul Clinic Fundeni
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Romania
      • Bucharest, Romania, 022328
        • Fundeni Clinical Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
28-days mortality
Time Frame: 28 days after ICU admission
28-days mortality
28 days after ICU admission

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institutul Clinic Fundeni

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 10, 2016

Primary Completion (ACTUAL)

July 30, 2021

Study Completion (ACTUAL)

July 30, 2021

Study Registration Dates

First Submitted

August 26, 2020

First Submitted That Met QC Criteria

August 26, 2020

First Posted (ACTUAL)

August 31, 2020

Study Record Updates

Last Update Posted (ACTUAL)

September 13, 2021

Last Update Submitted That Met QC Criteria

September 3, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Cyto-Sepsis

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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