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The impact of rhinovirus infections in children undergoing cardiac surgery


- candidate number21675
- NTR NumberNTR4999
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR11-feb-2015
- Secondary IDsP14.303 RV-MM-PED-1
- Public TitleThe impact of rhinovirus infections in children undergoing cardiac surgery
- Scientific Title‘The impact of rhinovirus infections in paediatric cardiac surgery’
- ACRONYMRISK
- hypothesiswe 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.
- Healt Condition(s) or Problem(s) studiedRhinovirus, Cardiac surgery, Respiratory infections, Post-operative complications
- 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
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 1-mrt-2015
- planned closingdate1-mrt-2016
- Target number of participants250
- InterventionsThe parents/guardians of the children will be asked to fill out a questionnaire before the operation of their child. In the operating theatre, a nasopharyngeal swab will collected in the children after induction of anaesthesia and thus without any discomfort. Clinical data will be collected daily during paediatric intensive care admission, and date of discharge from PICU and from hospital are recorded. 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.
- Primary outcomeThe primary study parameter is post-operative PICU length of stay in rhinovirus positive compared to rhinovirus negative patients.
- Secondary outcome Secondary outcome parameters are:
• Duration of ventilatory support
• Mechanical ventilation conditions (mean airway pressure, FiO2)
• Antibiotic free days (alive at PICU discharge)
• Need of inotropes (inotrope score)
• Infection parameters
• Hospital length of stay
• Secondary infections
- Timepointsday -1: questionnaire
day 0 (operation day) : collection of nasopharyngeal swab
day 4: if still intubated: nasopharyngeal swab will be sampled and scavenge samples blood will be requested at the chemical laboratory
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES R.B.P Wilde
- CONTACT for SCIENTIFIC QUERIES R.B.P Wilde
- Sponsor/Initiator Leiden University Medical Center (LUMC) Department of Medical Microbiology, Leiden University Medical Center (LUMC), Department of paediatric Intensive Care
- Funding
(Source(s) of Monetary or Material Support)
Leiden University Medical Center (LUMC) Department of Medical Microbiology, Leiden University Medical Center (LUMC) Department of paediatric Intensive Care
- Publications
- Brief summaryThis is a prospective single- center observational study in the Leiden University Medical Center in approximately 250 children (<12 years) undergoing elective cardiac surgery, for congenital heart disease. The parents/guardians of the children will be asked to fill out a questionnaire, to asses respiratory symptoms in the last weeks, before the operation of their child. In the operating theatre, a nasopharyngeal swab will collected. Clinical data will be collected daily during paediatric intensive care admission, and date of discharge from paediatric intensive care unit and from hospital are recorded. If children are still intubated at day 4 a second nasopharyngeal swab and residual blood will be collected. The samples will be tested for rhinovirus with a polymerase chain reaction. Main study parameter is the paediatric intensive care unit length of stay in per-operative rhinovirus –positive compared to rhinovirus-negative patients.
- Main changes (audit trail)
- RECORD11-feb-2015 - 30-jun-2015


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