Inflammation Clinical Trial
Official title:
The Importance of Wnt-signaling in the Pathobiology of Systemic Inflammation and Organ Dysfunction After Cardiac Surgery
NCT number | NCT04058496 |
Other study ID # | Wnt-study |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | November 1, 2018 |
Est. completion date | April 1, 2022 |
Verified date | July 2022 |
Source | University of Zurich |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 64 |
Est. completion date | April 1, 2022 |
Est. primary completion date | April 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Cardiac surgery via sternotomy - Coronary-bypass bypass surgery with or without valve surgery - Postoperative hospitalisation in the cardio-surgical ICU - Available informed consent Exclusion Criteria: - Preoperative infections (e.g. endocarditis) - Preoperative use of steroids or other immunosuppression |
Country | Name | City | State |
---|---|---|---|
Switzerland | University Hospital | Zürich |
Lead Sponsor | Collaborator |
---|---|
Alain Rudiger | University of Zurich |
Switzerland,
Hauffe T, Krüger 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. — View Citation
Hauffe T, Krüger 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Plasma concentration of Wnt5a (ng/ml) | Measured by a commercially available ELISA | Up to 48 hours after ICU admission | |
Primary | Plasma concentration of sFRP1 (ng/ml) | Measured by a commercially available ELISA | Up to 48 hours after ICU admission | |
Primary | Plasma concentration of sFRP5 (ng/ml) | Measured by a commercially available ELISA | Up to 48 hours after ICU admission | |
Primary | Plasma concentration of WIF-1 (pg/ml) | Measured by a commercially available ELISA | Up to 48 hours after ICU admission | |
Secondary | Daily fluid balance (ml) | Routine parameter taken from charts | Up to 48 hours after ICU admission | |
Secondary | 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 | Up to 7 days after ICU admission | |
Secondary | Length of ICU stay (days) | Routine parameter taken from charts | Up to 4 weeks |
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