The Importance of Wnt-signaling After Cardiac Surgery

NCT04058496 | Completed

• 1 other identifier: Wnt-study
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammation; Thoracic Surgery

Keywords

Cardia surgery; Cardio-pulmonary bypass; Inflammation; WNT; Cytokines

Outcome Measures

Primary Outcomes (4)

• Plasma concentration of Wnt5a (ng/ml)

  Measured by a commercially available ELISA

  Up to 48 hours after ICU admission

• Plasma concentration of sFRP1 (ng/ml)

  Measured by a commercially available ELISA

  Up to 48 hours after ICU admission

• Plasma concentration of sFRP5 (ng/ml)

  Measured by a commercially available ELISA

  Up to 48 hours after ICU admission

• Plasma concentration of WIF-1 (pg/ml)

  Measured by a commercially available ELISA

  Up to 48 hours after ICU admission

Secondary Outcomes (3)

• Daily fluid balance (ml)

  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

  Up to 7 days after ICU admission

• Length of ICU stay (days)

  Up to 4 weeks

Study Arms (3)

1

Coronary artery bypass surgery off-pump (n=24)

Other: Blood sampling

2

Coronary artery bypass surgery on-pump (n=16)

Other: Blood sampling

3

Coronary artery bypass surgery plus valve surgery (n=20)

Other: Blood sampling

Interventions

Blood sampling OTHER

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

1; 2; 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients after open cardiac surgery

You may qualify if:

• Cardiac surgery via sternotomy
• Coronary-bypass bypass surgery with or without valve surgery
• Postoperative hospitalisation in the cardio-surgical ICU
• Available informed consent

You may not qualify if:

• Preoperative infections (e.g. endocarditis)
• Preoperative use of steroids or other immunosuppression

Sponsors & Collaborators

• Alain Rudiger: lead
• University of Zurich: collaborator

Study Sites (1)

University Hospital

Zurich, Switzerland

Location

Related Publications (3)

• 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.

  PMID: 28785436 BACKGROUND

• 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.

  PMID: 28785454 BACKGROUND

• Kruger 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.

  PMID: 36440011 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood

MeSH Terms

Conditions

Inflammation

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Alain Rudiger, MD

  University of Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. med.

Study Record Dates

• First Submitted: June 21, 2019
• First Posted: August 15, 2019
• Study Start: November 1, 2018
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• Last Updated: July 21, 2022

Record last verified: 2022-07

Locations

CH (1)