'The Impact of Rhinovirus Infections in Paediatric Cardiac Surgery' (RISK)

September 24, 2020 updated by: JuttedeVries, Leiden University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
166

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Leiden, Netherlands
        • Leiden University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

No older than 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Children (<12 year) with a congenital heart disease undergoing elective cardiac surgery

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
children undergoing cardiac surgery
paediatric patients with a congenital heart disease undergoing elective cardiac surgery
Other: rhinovirus diagnostics
rhinovirus PCR on a nasopharyngeal swab

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Leiden University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Anneloes L Klink, Msc, Leiden University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 30, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 5, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 8, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 25, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 24, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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