InflammationNCT04058496
The Importance of Wnt-signaling After Cardiac Surgery
An observational study of Inflammation and Thoracic Surgery, run by Alain Rudiger at 1 site in Switzerland.
Trial summary
Cardiac surgery saves lives when patients suffer from cardiac disease. Local inflammation is important for tissue repair and wound healing after such an operation. Inflammation starts already when the patient is treated in the intensive care unit. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammation, Thoracic Surgery
- What is being tested?
- Blood sampling
- How many people
- 64 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Nov 2018to 1 Apr 2022
- 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: Patients after open cardiac surgery
Who may be able to join
- Cardiac surgery via sternotomy
- Coronary-bypass bypass surgery with or without valve surgery
- Postoperative hospitalisation in the cardio-surgical ICU
- Available informed consent
Who cannot join
- Preoperative infections (e.g. endocarditis)
- Preoperative use of steroids or other immunosuppression
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Importance of Wnt-signaling in the Pathobiology of Systemic Inflammation and Organ Dysfunction After Cardiac Surgery
Cardiac surgery saves lives when patients suffer from cardiac disease. Local inflammation is important for tissue repair and wound healing after such an operation. Inflammation starts already when the patient is treated in the intensive care unit. When inflammatory proteins (cytokines) are released into the circulation, they cause also a systemic inflammation, which alerts the immune system of the body and activates defence mechanisms (=adaptive response). In some patients, systemic inflammation is out of control thereby causing organ dysfunctions, shock, and in the most severe cases even death (=maladaptive response). The aim of this study is to investigate the early phase of inflammation after the operation. Repeated blood samples will be taken of patients undergoing cardiac surgery to describe the patterns and dynamics of inflammation proteins. A better understanding of these mechanisms will potentially lead to improved treatment of patients after cardiac surgery.
Read the detailed description
The aim of this project is to understand early inflammation mechanisms after cardiac surgery. Therefore, repeated blood samples of patients undergoing cardiac surgery will be taken. Patients are selected after "open" cardiac surgery (via sternotomy), when when they require postoperative care in the cardiovascular intensive care unit. The blood samples will be analysed in collaboration with the Inflammation Research Unit of the Department of Internal Medicine at the University Hospital Zurich.
- Conditions
- Inflammation, Thoracic Surgery
- Being tested
- Blood sampling
- Keywords
- Cardia surgery, Cardio-pulmonary bypass, Inflammation, WNT, Cytokines
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingOther
Five Timepoints: baseline (pre-operative), ICU admission, 4 hours after ICU admission, 8 hours after ICU admission, 48 hours after ICU admission
| Study group | Role | What they receive |
|---|---|---|
| 1 | Coronary artery bypass surgery off-pump (n=24) Receives: Other: Blood sampling | |
| 2 | Coronary artery bypass surgery on-pump (n=16) Receives: Other: Blood sampling | |
| 3 | Coronary artery bypass surgery plus valve surgery (n=20) Receives: Other: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentration of Wnt5a (ng/ml)
Measured by a commercially available ELISA
Measured: Up to 48 hours after ICU admission
Plasma concentration of sFRP1 (ng/ml)
Measured by a commercially available ELISA
Measured: Up to 48 hours after ICU admission
Plasma concentration of sFRP5 (ng/ml)
Measured by a commercially available ELISA
Measured: Up to 48 hours after ICU admission
Plasma concentration of WIF-1 (pg/ml)
Measured by a commercially available ELISA
Measured: Up to 48 hours after ICU admission
Secondary outcomes (3)
Daily fluid balance (ml)
Routine parameter taken from charts
Measured: Up to 48 hours after ICU admission
Occurrence of complications (yes/no): composite endpoint of hemodynamic instability (defined as norepinephrine concentration = or > 0.1mcg/kg/min), delirium (defined as ICDSC score = or > 4), infections
Routine parameter taken from charts
Measured: Up to 7 days after ICU admission
Length of ICU stay (days)
Routine parameter taken from charts
Measured: Up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2019
- Study start1 Nov 2018
- Primary completion1 Apr 2022
- Study completion1 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for InflammationStudies 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
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alain Rudiger
- Sponsor type
- University, hospital or other
- Collaborators
- University of Zurich
- Responsible party
- Sponsor-investigator, Alain Rudiger, University of Zurich
- Investigators
- Alain Rudiger, MD, Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04058496
- Sponsor's protocol ID
- Wnt-study
- Status last verified
- Jul 2022
- First submitted
- 21 Jun 2019
- Last updated
- 21 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hauffe T, Kruger B, Bettex D, Rudiger A. Shock Management for Cardio-surgical ICU Patients - The Golden Hours. Card Fail Rev. 2015 Oct;1(2):75-82. doi: 10.15420/cfr.2015.1.2.75.
PubMed 28785436Hauffe T, Kruger B, Bettex D, Rudiger A. Shock Management for Cardio-surgical Intensive Care Unit Patient: The Silver Days. Card Fail Rev. 2016 May;2(1):56-62. doi: 10.15420/cfr.2015:27:2.
PubMed 28785454Kruger BD, Hofer GE, Rudiger A, Spahn GH, Braun J, Bettex D, Schoedon G, Spahn DR. Wingless-related integration site (WNT) signaling is activated during the inflammatory response upon cardiac surgery: A translational study. Front Cardiovasc Med. 2022 Nov 11;9:997350. doi: 10.3389/fcvm.2022.997350. eCollection 2022.
PubMed 36440011
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Importance of Wnt-signaling in the Pathobiology of Systemic Inflammation and Organ Dysfunction After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT04058496
- Acronym / sponsor ID
- Wnt-study
- Conditions
- Inflammation, Thoracic Surgery
- Keywords
- Cardia surgery, Cardio-pulmonary bypass, Inflammation, WNT, Cytokines
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Alain RudigerUniversity, hospital or other
- Collaborators
- University of Zurich
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 15 Aug 2019 (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.
Cardiac surgery saves lives when patients suffer from cardiac disease. Local inflammation is important for tissue repair and wound healing after such an operation. Inflammation starts already when the patient is treated in the intensive care unit. When inflammatory proteins (cytokines) are released into the circulation, they cause also a systemic inflammation, which alerts the immune system of the body and activates defence mechanisms (=adaptive response). In some patients, systemic inflammation is out of control thereby causing organ dysfunctions, shock, and in the most severe cases even death (=maladaptive response). The aim of this study is to investigate the early phase of inflammation after the operation. Repeated blood samples will be taken of patients undergoing cardiac surgery to describe the patterns and dynamics of inflammation proteins. A better understanding of these mechanisms will potentially lead to improved treatment of patients after cardiac surgery.
Detailed description
The aim of this project is to understand early inflammation mechanisms after cardiac surgery. Therefore, repeated blood samples of patients undergoing cardiac surgery will be taken. Patients are selected after "open" cardiac surgery (via sternotomy), when when they require postoperative care in the cardiovascular intensive care unit. The blood samples will be analysed in collaboration with the Inflammation Research Unit of the Department of Internal Medicine at the University Hospital Zurich.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: Blood samplingCoronary artery bypass surgery off-pump (n=24) |
| 2 | – | Other: Blood samplingCoronary artery bypass surgery on-pump (n=16) |
| 3 | – | Other: Blood samplingCoronary artery bypass surgery plus valve surgery (n=20) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients after open cardiac surgery
Key inclusion criteria (4 listed)
- Cardiac surgery via sternotomy
- Coronary-bypass bypass surgery with or without valve surgery
- Postoperative hospitalisation in the cardio-surgical ICU
- Available informed consent
Key exclusion criteria (2 listed)
- Preoperative infections (e.g. endocarditis)
- Preoperative use of steroids or other immunosuppression
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 |
|---|---|---|
| Blood samplingFive Timepoints: baseline (pre-operative), ICU admission, 4 hours after ICU admission, 8 hours after ICU admission, 48 hours after ICU admission | Other | 1, 2, 3 |
Primary outcome
Plasma concentration of Wnt5a (ng/ml)
Time frame: Up to 48 hours after ICU admission
Measured by a commercially available ELISA
Plasma concentration of sFRP1 (ng/ml)
Time frame: Up to 48 hours after ICU admission
Measured by a commercially available ELISA
Plasma concentration of sFRP5 (ng/ml)
Time frame: Up to 48 hours after ICU admission
Measured by a commercially available ELISA
Plasma concentration of WIF-1 (pg/ml)
Time frame: Up to 48 hours after ICU admission
Measured by a commercially available ELISA
3 secondary outcomes
Daily fluid balance (ml)
Time frame: Up to 48 hours after ICU admission
Occurrence of complications (yes/no): composite endpoint of hemodynamic instability (defined as norepinephrine concentration = or > 0.1mcg/kg/min), delirium (defined as ICDSC score = or > 4), infections
Time frame: Up to 7 days after ICU admission
Length of ICU stay (days)
Time frame: Up to 4 weeks
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 21 Jul 2022.
- Background: PubMed 28785436Hauffe T, Kruger B, Bettex D, Rudiger A. Shock Management for Cardio-surgical ICU Patients - The Golden Hours. Card Fail Rev. 2015 Oct;1(2):75-82. doi: 10.15420/cfr.2015.1.2.75.
- Background: PubMed 28785454Hauffe T, Kruger B, Bettex D, Rudiger A. Shock Management for Cardio-surgical Intensive Care Unit Patient: The Silver Days. Card Fail Rev. 2016 May;2(1):56-62. doi: 10.15420/cfr.2015:27:2.
- Derived from this study: PubMed 36440011Kruger BD, Hofer GE, Rudiger A, Spahn GH, Braun J, Bettex D, Schoedon G, Spahn DR. Wingless-related integration site (WNT) signaling is activated during the inflammatory response upon cardiac surgery: A translational study. Front Cardiovasc Med. 2022 Nov 11;9:997350. doi: 10.3389/fcvm.2022.997350. eCollection 2022.
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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.
Alain Rudiger, MD principal investigator
University of Zurich
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 Inflammation and Thoracic Surgery, run by Alain Rudiger at 1 site in Switzerland.
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 4 inclusion and 2 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 21 Jul 2022. 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 Switzerland. 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?
Plasma concentration of Wnt5a (ng/ml) (time frame: Up to 48 hours after ICU admission). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04058496, which also lists 3 linked publications.
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 21 Jul 2022.