Clinical trial NCT04058496: The Importance of Wnt-signaling After Cardiac Surgery
Official title: The Importance of Wnt-signaling in the Pathobiology of Systemic Inflammation and Organ Dysfunction After Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammation
Thoracic Surgery
Keywords: Cardia surgery
Cardio-pulmonary bypass
Inflammation
WNT
Cytokines
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: University of Zurich
First posted: 2019-08-15
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients after open cardiac surgery

Brief 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Plasma concentration of Wnt5a (ng/ml)
timeFrame: Up to 48 hours after ICU admission
measure: Plasma concentration of sFRP1 (ng/ml)
timeFrame: Up to 48 hours after ICU admission
measure: Plasma concentration of sFRP5 (ng/ml)
timeFrame: Up to 48 hours after ICU admission
measure: Plasma concentration of WIF-1 (pg/ml)
timeFrame: Up to 48 hours after ICU admission
Secondary outcomes:
measure: Daily fluid balance (ml)
timeFrame: Up to 48 hours after ICU admission
measure: 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
timeFrame: Up to 7 days after ICU admission
measure: Length of ICU stay (days)
timeFrame: Up to 4 weeks
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: University Hospital
Study officials:
affiliation: University of Zurich
name: Alain Rudiger, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Hauffe 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.