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Completed

NCT Number: NCT04058496

The Importance of Wnt-signaling 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.

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Key information

Conditions

Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Thoracic Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital

Zurich, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Plasma concentration of Wnt5a (ng/ml)

    Time frame: Up to 48 hours after ICU admission

    Measured by a commercially available ELISA

  2. Plasma concentration of sFRP1 (ng/ml)

    Time frame: Up to 48 hours after ICU admission

    Measured by a commercially available ELISA

  3. Plasma concentration of sFRP5 (ng/ml)

    Time frame: Up to 48 hours after ICU admission

    Measured by a commercially available ELISA

  4. Plasma concentration of WIF-1 (pg/ml)

    Time frame: Up to 48 hours after ICU admission

    Measured by a commercially available ELISA

Secondary outcomes

  1. Daily fluid balance (ml)

    Time frame: Up to 48 hours after ICU admission

    Routine parameter taken from charts

  2. 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

    Routine parameter taken from charts

  3. Length of ICU stay (days)

    Time frame: Up to 4 weeks

    Routine parameter taken from charts

Sponsors and collaborators

Lead sponsor

Alain Rudiger

Other

Collaborators

  • University of Zurich

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Aug 15, 2019
Registry last updated
Jul 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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