Sepsis - to Reduce Mortality in the Intensive Care UnitNCT06735365
Comparative Effectiveness of Oxiris Hemofilters Versus Conventional Hemofilters in Septic Patients
An observational study of Sepsis - to Reduce Mortality in the Intensive Care Unit and Hemodiafiltration, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis - to Reduce Mortality in the Intensive Care Unit, Hemodiafiltration, Cytokine
- What is being tested?
- CRRT
- How many people
- 426 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 May 2024to 1 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older 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
Who may be able to join
- sepsis diagnosis CRRT indication
Who cannot join
- patients under age of 18
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bakirkoy Dr Sadi Konuk Research and Training Hospital
Istanbul
About this study
Official title: Comparative Effectiveness of Oxiris Filters Versus Conventional Hemofilters in Septic Patients: a Retrospective Cohort Study
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.
- Being tested
- CRRT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRRTOther
Hemodiafiltration
| Study group | Role | What they receive |
|---|---|---|
| Oxiris | The group which we used oxiris filter for CRRT. Receives: Other: CRRT | |
| Non-Oxiris | The group which we used other filters like M150 for CRRT. Receives: Other: CRRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
SOFA Score
We compared SOFA scores of patients on admission and on 5th day.
Measured: 6 month
Secondary outcomes (1)
Survival comparison
We compared patients survival rates between two group.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start23 May 2024
- Primary completion1 Nov 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sepsis - to Reduce Mortality in the Intensive Care UnitStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 426 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06735365
- Sponsor's protocol ID
- 2024-05-02
- Status last verified
- Dec 2024
- First submitted
- 11 Dec 2024
- Last updated
- 31 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Oxiris Filters Versus Conventional Hemofilters in Septic Patients: a Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT06735365
- Acronym / sponsor ID
- 2024-05-02
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 426 participants (actual)
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training HospitalOther government
- Study start
- 23 May 2024 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 16 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxiris | – | Other: CRRTThe group which we used oxiris filter for CRRT. |
| Non-Oxiris | – | Other: CRRTThe group which we used other filters like M150 for CRRT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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
Key inclusion criteria (1 listed)
- sepsis diagnosis CRRT indication
Key exclusion criteria (1 listed)
- patients under age of 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CRRTHemodiafiltration | Other | Non-Oxiris, Oxiris |
Primary outcome
SOFA Score
Time frame: 6 month
We compared SOFA scores of patients on admission and on 5th day.
1 secondary outcome
Survival comparison
Time frame: 6 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis - to Reduce Mortality in the Intensive Care Unit and Hemodiafiltration, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SOFA Score (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2024.