- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02438293
'The Impact of Rhinovirus Infections in Paediatric Cardiac Surgery' (RISK)
Study Overview
Status
Intervention / Treatment
Detailed Description
Rationale:
Respiratory infections are considered to carry a potential risk of adverse events in children undergoing surgery.
Rhinovirus is a common cause of respiratory infections and congenital heart disease is a risk factor for severe rhinovirus infection. However, we do not know what the impact of clinical or subclinical rhinovirus infections is on postoperative course following congenital heart surgery in children.
Based on our clinical experience, one case-controlled study , and a case reported in the literature, we hypothesize that paediatric patients with per-operative rhinovirus positive Polymerase Chain Reaction (PCR) testing have a longer paediatric intensive care unit (PICU) admission , compared to children who test negative.
Objectives:
Primary: To identify whether PCR-proven rhinovirus is a risk factor for prolonged PICU admission in children undergoing cardiac surgery.
Secondary: to develop a preoperative algorithm to identify children with increased risk for prolonged PICU admission after cardiac surgery.
Study design:
This is a prospective single-center observational cohort study in the Leiden University Medical Center (LUMC).
Methods Parents of the selected patients will receive the information folder and a questionnaire by mail (asking for signs and symptoms of current and/or recent respiratory infections) when they receive the letter with the date of admission and operation.
On the day of admission (day -1) all (parents of) children admitted for cardiac surgery will be asked to participate in this study and fill out a written informed consent.
At day 0, the operation day, in the operating theatre a nasopharyngeal swab will be collected following anaesthetic induction and tested for rhinovirus. All clinicians will be blinded for the PCR results and will only be made known to the investigator from the virology department.
Clinical and laboratory data will be collected for all patients until discharge from the hospital. Of all the patients still on mechanical ventilation at day 4, an additional nasopharyngeal swab will be sampled and scavenge samples blood will be requested at the chemical laboratory if available. Rhinovirus PCR will be performed on nasopharyngeal swab and blood to determine shedding and viremia.
Residual blood (for infection parameters) will be collected at three time points: after induction of anaesthesia, directly after operation at PICU admission and at day four (4) when the patient is still on ventilator support.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Leiden, Netherlands
- Leiden University Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Children (<12 year) with a congenital heart disease undergoing elective cardiac surgery
- Written informed consent by parents or guardian
Exclusion Criteria:
- No informed consent from one of the parents (or the legal representative if applicable)
- Anaesthesiologist or cardiopulmonary surgeon postpones surgery based on routine hospital screening
- Emergency surgery
- Pre-operative admission to the neonatology department
- Children not admitted to the intensive care unit after cardiac surgery
- Children undergoing a second cardiac operation during the same intensive care stay
- Children with duct-dependent physiology who remain prostaglandin-dependent after the heart operation (they will be excluded because they will certainly have a prolonged PICU LOS regardless of a possible rhinovirus infection). For example: hypoplastic left heart syndrome following pulmonary artery banding who will remain on prostaglandins until the next staged operation
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
children undergoing cardiac surgery
paediatric patients with a congenital heart disease undergoing elective cardiac surgery
|
rhinovirus PCR on a nasopharyngeal swab
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
post-operative PICU length of stay
Time Frame: participants will be followed for the duration of PICU stay, an expected average of 3,8 days
|
rhinovirus PCR positive compared to rhinovirus negative patients
|
participants will be followed for the duration of PICU stay, an expected average of 3,8 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Duration of ventilatory support
Time Frame: participants will be followed for the duration of PICU stay, an expected average of 3,8 days
|
participants will be followed for the duration of PICU stay, an expected average of 3,8 days
|
mean airway pressure
Time Frame: participants will be followed for the duration of PICU stay, an expected average of 3,8 days
|
participants will be followed for the duration of PICU stay, an expected average of 3,8 days
|
FiO2
Time Frame: participants will be followed for the duration of PICU stay, an expected average of 3,8 days
|
participants will be followed for the duration of PICU stay, an expected average of 3,8 days
|
peak inspiratory pressure (maximum values)
Time Frame: participants will be followed for the duration of PICU stay, an expected average of 3,8 days
|
participants will be followed for the duration of PICU stay, an expected average of 3,8 days
|
positive end expiratory pressure (maximum values)
Time Frame: participants will be followed for the duration of PICU stay, an expected average of 3,8 days
|
participants will be followed for the duration of PICU stay, an expected average of 3,8 days
|
Antibiotic free days (alive at PICU discharge)
Time Frame: participants will be followed for the duration of PICU stay, an expected average of 3,8 days
|
participants will be followed for the duration of PICU stay, an expected average of 3,8 days
|
Need of inotropes (inotrope score)
Time Frame: participants will be followed for the duration of PICU stay, an expected average of 3,8 days
|
participants will be followed for the duration of PICU stay, an expected average of 3,8 days
|
CRP
Time Frame: participants will be followed for the duration of PICU stay, an expected average of 3,8 days
|
participants will be followed for the duration of PICU stay, an expected average of 3,8 days
|
Leukocytes
Time Frame: participants will be followed for the duration of PICU stay, an expected average of 3,8 days
|
participants will be followed for the duration of PICU stay, an expected average of 3,8 days
|
Hospital length of stay
Time Frame: participants will be followed for the duration of PICU stay, an expected average of 3,8 days
|
participants will be followed for the duration of PICU stay, an expected average of 3,8 days
|
Any secondary infection (bacterial, viral and parasitic infections)
Time Frame: participants will be followed for the duration of PICU stay, an expected average of 3,8 days
|
participants will be followed for the duration of PICU stay, an expected average of 3,8 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Anneloes L Klink, Msc, Leiden University Medical Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P14.303
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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