Comparative Effectiveness of Oxiris Hemofilters Versus Co... | NCT06735365

Studies
Comparative Effectiveness of Oxiris Hemofilters Versus Conventional Hemofilters in Septic Patients

NCT06735365

Sponsor

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Status

Completed

Last Update Posted

Dec 31, 2024Actual

Enrollment

426Actual

Phase

Not provided

Conditions

Sepsis - to Reduce Mortality in the Intensive Care Unit
Hemodiafiltration
Cytokine

Interventions

CRRT

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 23, 2024Actual

Primary Completion Date

Nov 1, 2024Actual

Completion Date

Dec 1, 2024Actual

First Submitted Date

Dec 11, 2024

First Submission Date that Met QC Criteria

Dec 11, 2024

First Posted Date

Dec 16, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 26, 2024

Last Update Posted Date

Dec 31, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

We divided patients in 2 groups. First group was the patients who received Oxiris filters during CRRT. Second group was the patiens who have received CRRT filters other than Oxiris.

We compared the lab parameters (Urea, Creatinin, Lactate, ABG parameters and SOFA escore with together.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

426Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Oxiris		The group which we used oxiris filter for CRRT.	Other: CRRT
Non-Oxiris		The group which we used other filters like M150 for CRRT.	Other: CRRT

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CRRT	Other	Hemodiafiltration	Non-Oxiris Oxiris

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
SOFA Score	We compared SOFA scores of patients on admission and on 5th day.	6 month

Secondary Outcomes

Measure	Description	Time Frame
Survival comparison	We compared patients survival rates between two group.	6 month

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

sepsis diagnosis CRRT indication

Exclusion Criteria:

patients under age of 18

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

study population includes patients who have admission on our clinic for more than 5 days and diagnosed with sepsis who has CRRT indication

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bakirkoy Dr Sadi Konuk Research and Training Hospital		Istanbul			Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided