RhinovirusRISKNCT02438293
'The Impact of Rhinovirus Infections in Paediatric Cardiac Surgery'
An observational study of Rhinovirus and Congenital Heart Disease, run by Leiden University at 1 site in Netherlands.
Trial summary
This 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. Read more about this study
- Who is it for?
- Ages Up to 12 years
- Conditions the study is for
- Rhinovirus, Congenital Heart Disease, Respiratory Infections
- What is being tested?
- rhinovirus diagnostics
- How many people
- 166 participants
- Where
- 1 siteNetherlands
- Study dates
- Jun 2015to Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: Children (<12 year) with a congenital heart disease undergoing elective cardiac surgery
Who may be able to join
- Children (<12 year) with a congenital heart disease undergoing elective cardiac surgery
- Written informed consent by parents or guardian
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
This 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.
Read the 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.
- Conditions
- Rhinovirus, Congenital Heart Disease, Respiratory Infections, Post-operative Complications
- Being tested
- rhinovirus diagnostics
- Keywords
- rhinovirus, cardiac surgery, paediatric, respiratory infection, children
- Medical subject headings
- Heart Defects, Congenital, Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rhinovirus diagnosticsOther
rhinovirus PCR on a nasopharyngeal swab
| Study group | Role | What they receive |
|---|---|---|
| children undergoing cardiac surgery | paediatric patients with a congenital heart disease undergoing elective cardiac surgery Receives: Other: rhinovirus diagnostics |
What is being measured
The primary outcome is the main question the study is designed to answer.
post-operative PICU length of stay
rhinovirus PCR positive compared to rhinovirus negative patients
Measured: participants will be followed for the duration of PICU stay, an expected average of 3,8 days
Secondary outcomes (11)
Duration of ventilatory support
Measured: participants will be followed for the duration of PICU stay, an expected average of 3,8 days
mean airway pressure
Measured: participants will be followed for the duration of PICU stay, an expected average of 3,8 days
FiO2
Measured: participants will be followed for the duration of PICU stay, an expected average of 3,8 days
peak inspiratory pressure (maximum values)
Measured: participants will be followed for the duration of PICU stay, an expected average of 3,8 days
positive end expiratory pressure (maximum values)
Measured: participants will be followed for the duration of PICU stay, an expected average of 3,8 days
Antibiotic free days (alive at PICU discharge)
Measured: participants will be followed for the duration of PICU stay, an expected average of 3,8 days
Need of inotropes (inotrope score)
Measured: participants will be followed for the duration of PICU stay, an expected average of 3,8 days
CRP
Measured: participants will be followed for the duration of PICU stay, an expected average of 3,8 days
Leukocytes
Measured: participants will be followed for the duration of PICU stay, an expected average of 3,8 days
Hospital length of stay
Measured: 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)
Measured: participants will be followed for the duration of PICU stay, an expected average of 3,8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2015 (estimated)
- Study startJun 2015
- Primary completionJun 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for RhinovirusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leiden University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JuttedeVries, Leiden University Medical Center
- Investigators
- Anneloes L Klink, Msc, Principal investigator, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02438293
- Sponsor's protocol ID
- P14.303
- Acronym
- RISK
- Status last verified
- Sep 2020
- First submitted
- 30 Apr 2015
- Last updated
- 25 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Roeleveld PP, Van Rijn AL, de Wilde RBP, van Zwet EW, Wink J, Rozendaal L, Hogenbirk K, Hazekamp MG, Man WH, Sidorov I, Kraakman MEM, Claas ECJ, de Jonge E, Kroes ACM, de Vries JJC. Rhinovirus Detection in the Nasopharynx of Children Undergoing Cardiac Surgery Is Not Associated With Longer PICU Length of Stay: Results of the Impact of Rhinovirus Infection After Cardiac Surgery in Kids (RISK) Study. Pediatr Crit Care Med. 2021 Jan 1;22(1):e79-e90. doi: 10.1097/PCC.0000000000002522.
PubMed 33027243
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 'The Impact of Rhinovirus Infections in Paediatric Cardiac Surgery'
- ClinicalTrials.gov ID
- NCT02438293
- Acronym / sponsor ID
- RISK / P14.303
- Conditions
- Rhinovirus, Congenital Heart Disease, Respiratory Infections, Post-operative Complications
- Keywords
- rhinovirus, cardiac surgery, paediatric, respiratory infection, children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- Leiden UniversityUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 8 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This 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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| children undergoing cardiac surgery | – | Other: rhinovirus diagnosticspaediatric patients with a congenital heart disease undergoing elective cardiac surgery |
Who may qualify
- Ages
- Up to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children (<12 year) with a congenital heart disease undergoing elective cardiac surgery
Key inclusion criteria (2 listed)
- Children (<12 year) with a congenital heart disease undergoing elective cardiac surgery
- Written informed consent by parents or guardian
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rhinovirus diagnosticsrhinovirus PCR on a nasopharyngeal swab | Other | children undergoing cardiac surgery |
Primary outcome
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
11 secondary outcomes
Duration of ventilatory support
Time frame: 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
FiO2
Time frame: 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
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
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
Need of inotropes (inotrope score)
Time frame: 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
Leukocytes
Time frame: 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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2020.
- Derived from this study: PubMed 33027243Roeleveld PP, Van Rijn AL, de Wilde RBP, van Zwet EW, Wink J, Rozendaal L, Hogenbirk K, Hazekamp MG, Man WH, Sidorov I, Kraakman MEM, Claas ECJ, de Jonge E, Kroes ACM, de Vries JJC. Rhinovirus Detection in the Nasopharynx of Children Undergoing Cardiac Surgery Is Not Associated With Longer PICU Length of Stay: Results of the Impact of Rhinovirus Infection After Cardiac Surgery in Kids (RISK) Study. Pediatr Crit Care Med. 2021 Jan 1;22(1):e79-e90. doi: 10.1097/PCC.0000000000002522.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anneloes L Klink, Msc principal investigator
Leiden University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rhinovirus and Congenital Heart Disease, run by Leiden University at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02438293, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2020.