Systemic Inflammatory Response SyndromeNCT02957175
Immunophenotyping of Patients With Postoperative SIRS
An observational study of Systemic Inflammatory Response Syndrome, run by University of Bonn at 1 site in Germany.
Trial summary
The purpose of this study is to develop an immune-phenotype based prediction of postoperative SIRS in patients undergoing open heart surgery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Systemic Inflammatory Response Syndrome
- What is being tested?
- Immunophenotyping
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2016to May 2021
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients undergoing open heart surgery.
Who may be able to join
- Age > 18 years
- Informed consent of the patient
- Patient undergoing a open heart surgery using a cardiopulmonary bypass
Who cannot join
- Age < 18 years
- Missing informed consent
- Renal failure
- Liver failure
- Neurodegenerative disease
- Malignancies
- Immune therapy
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Bonn
Bonn, 53127
Chrisitan Bode, MD, +4922828714119, christian.bode@ukb.uni-bonn.de
About this study
Official title: Immunophenotyping of Patients Undergoing Open Heart Surgery to Assess Their Susceptibility of Developing a Systemic Inflammatory Response Syndrome (SIRS)
The purpose of this study is to develop an immune-phenotype based prediction of postoperative SIRS in patients undergoing open heart surgery.
Read the detailed description
The study will have a pre-, intra and postoperative phase in which several demographic and clinical variables will be assessed. The samples for the immunophenotypic analysis will be drawn directly after induction of anesthesia and at various time points after end of surgery. The diagnosis of SIRS will be made during routine clinical visits on the first seven postoperative days using the Sepsis-related Organ Failure Assessment score (SOFA-score). The patients will be followed up for 30 days.
- Conditions
- Systemic Inflammatory Response Syndrome
- Being tested
- Immunophenotyping
- Keywords
- Immunophenotyping, Perioperative Care, Innate Immunity, Cardiac Surgical Procedures
- Medical subject headings
- Systemic Inflammatory Response Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImmunophenotypingOther
Multiplex assays for screening pro- and anti-inflammatory markers and RNA will be analysed using a next generation sequencing approach
| Study group | Role | What they receive |
|---|---|---|
| Patients that develop SIRS | Immunophenotyping of patients that develop SIRS after heart surgery Receives: Other: Immunophenotyping | |
| Patients that develop no SIRS | Immunophenotyping of patients that develop no SIRS after heart surgery Receives: Other: Immunophenotyping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with SIRS as assessed by SOFA-Score
The study investigates the relationship between the intra-individual inflammatory patterns in patients with uncomplicated (no SIRS) and complicated postoperative courses (SIRS) after open heart surgery.
The diagnosis of SIRS will be made by using the Sepsis-related Organ Failure Assessment score (SOFA-score). Patients with an increase in SOFA-score >3 are considered to have SIRS.
Measured: 30 days
Secondary outcomes (8)
Number of participants with need for renal replacement therapy because of acute kidney failure (AKIN classification)
Measured: 30 days
Number of participants with infection as assessed by microbiological, serological and radiological examination
Measured: 30 days
Number of participants with postoperative delir as assessed by CAM-ICU
Measured: 30 days
Number of participants with myocardial injury as assessed by troponine and CK-MB serum levels
Measured: 30 days
Number of participants with new atrial fibrillation as assessed by ECG
Measured: 30 days
Length of stay in ICU
Measured: 30 days
Length of stay in hospital
Measured: 30 days
In-hospital mortality
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionMar 2021 (estimated)
- Study completionMay 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Inflammatory Response SyndromeStudies 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
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bonn
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Christian Bode, University of Bonn
- Investigators
- Eicke Latz, MD, PhD, Study chair, Institute of Innate ImmunityChristian Bode, MD, Study chair, Department of Anesthesia and Critical Care MedicineFolkert M Steinhagen, MD, Principal investigator, Department of Anesthesia and Critical Care Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02957175
- Sponsor's protocol ID
- BOST-001
- Status last verified
- Apr 2020
- First submitted
- 30 Sep 2016
- Last updated
- 24 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunophenotyping of Patients Undergoing Open Heart Surgery to Assess Their Susceptibility of Developing a Systemic Inflammatory Response Syndrome (SIRS)
- ClinicalTrials.gov ID
- NCT02957175
- Acronym / sponsor ID
- BOST-001
- Conditions
- Systemic Inflammatory Response Syndrome
- Keywords
- Immunophenotyping, Perioperative Care, Innate Immunity, Cardiac Surgical Procedures
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of BonnUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 7 Nov 2016 (estimated)
- 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.
The purpose of this study is to develop an immune-phenotype based prediction of postoperative SIRS in patients undergoing open heart surgery.
Detailed description
The study will have a pre-, intra and postoperative phase in which several demographic and clinical variables will be assessed. The samples for the immunophenotypic analysis will be drawn directly after induction of anesthesia and at various time points after end of surgery. The diagnosis of SIRS will be made during routine clinical visits on the first seven postoperative days using the Sepsis-related Organ Failure Assessment score (SOFA-score). The patients will be followed up for 30 days.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients that develop SIRS | – | Other: ImmunophenotypingImmunophenotyping of patients that develop SIRS after heart surgery |
| Patients that develop no SIRS | – | Other: ImmunophenotypingImmunophenotyping of patients that develop no SIRS after heart surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing open heart surgery.
Key inclusion criteria (3 listed)
- Age > 18 years
- Informed consent of the patient
- Patient undergoing a open heart surgery using a cardiopulmonary bypass
Key exclusion criteria (7 listed)
- Age < 18 years
- Missing informed consent
- Renal failure
- Liver failure
- Neurodegenerative disease
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 |
|---|---|---|
| ImmunophenotypingMultiplex assays for screening pro- and anti-inflammatory markers and RNA will be analysed using a next generation sequencing approach | Other | Patients that develop SIRS, Patients that develop no SIRS |
Primary outcome
Number of participants with SIRS as assessed by SOFA-Score
Time frame: 30 days
The study investigates the relationship between the intra-individual inflammatory patterns in patients with uncomplicated (no SIRS) and complicated postoperative courses (SIRS) after open heart surgery. The diagnosis of SIRS will be made by using the Sepsis-related Organ Failure Assessment score (SOFA-score). Patients with an increase in SOFA-score >3 are considered to have SIRS.
8 secondary outcomes
Number of participants with need for renal replacement therapy because of acute kidney failure (AKIN classification)
Time frame: 30 days
Number of participants with infection as assessed by microbiological, serological and radiological examination
Time frame: 30 days
Number of participants with postoperative delir as assessed by CAM-ICU
Time frame: 30 days
Number of participants with myocardial injury as assessed by troponine and CK-MB serum levels
Time frame: 30 days
Number of participants with new atrial fibrillation as assessed by ECG
Time frame: 30 days
Length of stay in ICU
Time frame: 30 days
Length of stay in hospital
Time frame: 30 days
In-hospital mortality
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2020.
- Related InfoLink provided by the sponsor.
- 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.
Eicke Latz, MD, PhD study chair
Institute of Innate Immunity
Christian Bode, MD study chair
Department of Anesthesia and Critical Care Medicine
Folkert M Steinhagen, MD principal investigator
Department of Anesthesia and Critical Care Medicine
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 Systemic Inflammatory Response Syndrome, run by University of Bonn at 1 site in Germany.
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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 24 Apr 2020. 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christian Bode, MD (+4922828714119, christian.bode@ukb.uni-bonn.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with SIRS as assessed by SOFA-Score (time frame: 30 days). 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 24 Apr 2020.