Effects of Renal Replacement Therapy With Hemoadsoption in Patients With Sepsis

• Sponsor: Institutul Clinic Fundeni (Other)
• Overall Status: Completed
• CT.gov ID: NCT04533256
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Actual Duration (Months): 60.6
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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	Phase
Sepsis	Procedure: CytoSorb

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 30 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Effects of Renal Replacement Therapy With Hemoadsoption in Patients With Sepsis
• Actual Study Start Date: Jul 10, 2016
• Actual Primary Completion Date: Jul 30, 2021
• Actual Study Completion Date: Jul 30, 2021

Outcome Measures

Primary Outcome Measures

1. 28-days mortality [28 days after ICU admission]

   28-days mortality

Secondary Outcome Measures

1. severity score [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

Eligibility Criteria

Criteria

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

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fundeni Clinical Institute	Bucharest		Romania	022328

Sponsors and Collaborators

• Institutul Clinic Fundeni

Investigators

• Study Chair: Dana Tomescu, Prof, Fundeni Clinical Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Popescu Mihai, clinical professor, Institutul Clinic Fundeni
• ClinicalTrials.gov Identifier: NCT04533256
• Other Study ID Numbers: Cyto-Sepsis
• First Posted: Aug 31, 2020
• Last Update Posted: Sep 13, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Keywords provided by Popescu Mihai, clinical professor, Institutul Clinic Fundeni: organ failure; renal replacement therapy; hemoadsorption
• Additional relevant MeSH terms: Sepsis; Toxemia

Study Results

No Results Posted as of Sep 13, 2021