The Importance of Wnt-signaling After Cardiac Surgery

Inflammation Clinical Trial

Official title:

The Importance of Wnt-signaling in the Pathobiology of Systemic Inflammation and Organ Dysfunction After Cardiac Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04058496
• Other study ID #: Wnt-study
• Status: Completed
• Start date: November 1, 2018
• Est. completion date: April 1, 2022

Study information

• Verified date: July 2022
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Inflammation
• Thoracic Surgery

Intervention

Other:
• Blood sampling
Five Timepoints: baseline (pre-operative), ICU admission, 4 hours after ICU admission, 8 hours after ICU admission, 48 hours after ICU admission

Locations

Country	Name	City	State
Switzerland	University Hospital	Zürich

Sponsors (2)

Lead Sponsor	Collaborator
Alain Rudiger	University of Zurich

Country where clinical trial is conducted

Switzerland, 

References & Publications (2)

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

Outcome

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