SIRSCADDIE2NCT03661450
Evaluation of CDSS in Detection of SIRS and Sepsis in Pediatric Patients
An observational study of SIRS and Sepsis, run by Hannover Medical School at 1 site in Germany.
Trial summary
This trial aims to evaluate the accuracy of a Clinical Decision-Support System to support early recognition of SIRS in paediatric intensive care patients. This assessment will be rated by the primary goals, the sensitivity and specificity of the system. Read more about this study
- Who is it for?
- Ages Up to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- SIRS, Sepsis, Pediatric SIRS
- What is being tested?
- Clinical Decision-Support System
- How many people
- 177 participants
- Where
- 1 siteGermany
- Study dates
- 1 Aug 2018to 31 Mar 2019
- 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 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Pediatric patients from newborn to young adults up to 18 years that are admitted to our PICU, there is a wide range from infectious causes, post-operative-care of pediatric surgery, cardiac surgery, organ-transplants etc, newborns connatal syndromes and organdysplasia.
Who may be able to join
- all pediatric patients admitted to our PICU
Who cannot join
- patients that are supposed to stay for less than 12 hours on our PICU
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Accuracy of a Clinical Decision-Support System (CDSS) to Support Detection of SIRS and Sepsis in Paediatric Intensive Care Patients Compared to Medical Specialists
This trial aims to evaluate the accuracy of a Clinical Decision-Support System to support early recognition of SIRS in paediatric intensive care patients. This assessment will be rated by the primary goals, the sensitivity and specificity of the system. Two experienced paediatric intensivists, who are blinded for the CDSS results, will analyse the electronic patient file (EPF) for SIRS criteria and thus establish our Goldstandard. All SIRS events recognized by the CDSS during the patient's stay are taken into account and will be compared with the established Goldstandard.
The secondary goal of this trial is to evaluate the CDSS-results with the assessment of SIRS by paediatric doctors during their routine work on the PICU.
Read the detailed description
Clinical decision-support systems (CDSS) are designed to solve knowledge-intensive tasks for supporting decision-making processes. Although many approaches for designing CDSS have been proposed, due to high implementation costs, as well as the lack of interoperability features, current solutions are not wellestablished across different institutions. Recently, the use of standardized formalisms for knowledge representation as terminologies as well as the integration of semantically enriched clinical information models, as openEHR Archetypes, and their reuse within CDSS are theoretically considered as key factors for reusable CDSS. The investigators already successfully transferred their concept into a prototype and evaluated the practicability on clinical data sets and in close cooperation between the clinicians and the technical experts. To the author's knowledge, currently, there are no openEHR based CDSS approaches which have been implemented and evaluated with such complex and important clinical contexts. Hence, the first clinically evaluated CDSS based on openEHR was successfully designed. When enhancing the described approach and implementing a live system, it might support clinicians to identify the patient's course of disease at an early stage, which can lead to better outcome for the patient. Furthermore, the system can serve as a basis for integrating (cross-institutional) machine learning components that could facilitate dealing with other high-complex decision problems or revealing yet unknown disease patterns.
- Conditions
- SIRS, Sepsis, Pediatric SIRS
- Being tested
- Clinical Decision-Support System
- Keywords
- Clinical Decision-Support System
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical Decision-Support SystemDiagnostic test
Patient Data is evaluated by a Clinical Decision-Support System searching for age-adapted pediatric SIRS-criteria, aiming for a high sensitivity and specificity
| Study group | Role | What they receive |
|---|---|---|
| PICU-Patients | Pediatric patients admitted after 01.08.2018 Receives: Diagnostic Test: Clinical Decision-Support System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of CDSS compared to Goldstandard
Assessment of sensitivity and specificity of a CDSS compared to Goldstandard established by two independed blinded paediatric intensivists, the analysis will be done with Wald-Confidence interval and comparison of the lower limit of the confidence interval with the defined range of the null hypothesis.
Measured: 8 months
Secondary outcomes (2)
Sensitivity and specificity of CDSS on daily level
Evaluation of sensitivity and specificity of the CDSS on daily levels compared with the Goldstandard with respect to correlation of days within one patient's course with general estimating equations.
Measured: 8 months
Comparison of CDSS with assessment of MDs taking care of the patients
Evaluation of sensitivity and specificity of the CDSS on daily level and patient level compared with recognition of SIRS by paediatric doctors during daily routine with McNemar testing and general estimating equations.
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2018
- Study start1 Aug 2018
- Primary completion31 Mar 2019
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SIRSStudies 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
- 177 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- Technische Universitaet Braunschweig, Helmholtz Centre for Infection Research
- Responsible party
- Sponsor
- Investigators
- Michael Marschollek, PhD, Study chair, Hannover Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03661450
- Sponsor's protocol ID
- 7804_BO_S_2018
- Acronym
- CADDIE2
- Status last verified
- Aug 2019
- First submitted
- 5 Sep 2018
- Last updated
- 14 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wulff A, Montag S, Rubsamen N, Dziuba F, Marschollek M, Beerbaum P, Karch A, Jack T. Clinical evaluation of an interoperable clinical decision-support system for the detection of systemic inflammatory response syndrome in critically ill children. BMC Med Inform Decis Mak. 2021 Feb 18;21(1):62. doi: 10.1186/s12911-021-01428-7.
PubMed 33602206Wulff A, Montag S, Steiner B, Marschollek M, Beerbaum P, Karch A, Jack T. CADDIE2-evaluation of a clinical decision-support system for early detection of systemic inflammatory response syndrome in paediatric intensive care: study protocol for a diagnostic study. BMJ Open. 2019 Jun 19;9(6):e028953. doi: 10.1136/bmjopen-2019-028953.
PubMed 31221891
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Accuracy of a Clinical Decision-Support System (CDSS) to Support Detection of SIRS and Sepsis in Paediatric Intensive Care Patients Compared to Medical Specialists
- ClinicalTrials.gov ID
- NCT03661450
- Acronym / sponsor ID
- CADDIE2 / 7804_BO_S_2018
- Conditions
- SIRS, Sepsis, Pediatric SIRS
- Keywords
- Clinical Decision-Support System
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 177 participants (actual)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Collaborators
- Technische Universitaet Braunschweig, Helmholtz Centre for Infection Research
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 7 Sep 2018 (actual)
- 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 trial aims to evaluate the accuracy of a Clinical Decision-Support System to support early recognition of SIRS in paediatric intensive care patients. This assessment will be rated by the primary goals, the sensitivity and specificity of the system. Two experienced paediatric intensivists, who are blinded for the CDSS results, will analyse the electronic patient file (EPF) for SIRS criteria and thus establish our Goldstandard. All SIRS events recognized by the CDSS during the patient's stay are taken into account and will be compared with the established Goldstandard.
The secondary goal of this trial is to evaluate the CDSS-results with the assessment of SIRS by paediatric doctors during their routine work on the PICU.
Detailed description
Clinical decision-support systems (CDSS) are designed to solve knowledge-intensive tasks for supporting decision-making processes. Although many approaches for designing CDSS have been proposed, due to high implementation costs, as well as the lack of interoperability features, current solutions are not wellestablished across different institutions. Recently, the use of standardized formalisms for knowledge representation as terminologies as well as the integration of semantically enriched clinical information models, as openEHR Archetypes, and their reuse within CDSS are theoretically considered as key factors for reusable CDSS. The investigators already successfully transferred their concept into a prototype and evaluated the practicability on clinical data sets and in close cooperation between the clinicians and the technical experts. To the author's knowledge, currently, there are no openEHR based CDSS approaches which have been implemented and evaluated with such complex and important clinical contexts. Hence, the first clinically evaluated CDSS based on openEHR was successfully designed. When enhancing the described approach and implementing a live system, it might support clinicians to identify the patient's course of disease at an early stage, which can lead to better outcome for the patient. Furthermore, the system can serve as a basis for integrating (cross-institutional) machine learning components that could facilitate dealing with other high-complex decision problems or revealing yet unknown disease patterns.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PICU-Patients | – | Diagnostic Test: Clinical Decision-Support SystemPediatric patients admitted after 01.08.2018 |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Pediatric patients from newborn to young adults up to 18 years that are admitted to our PICU, there is a wide range from infectious causes, post-operative-care of pediatric surgery, cardiac surgery, organ-transplants etc, newborns connatal syndromes and organdysplasia.
Key inclusion criteria (1 listed)
- all pediatric patients admitted to our PICU
Key exclusion criteria (1 listed)
- patients that are supposed to stay for less than 12 hours on our PICU
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 |
|---|---|---|
| Clinical Decision-Support SystemPatient Data is evaluated by a Clinical Decision-Support System searching for age-adapted pediatric SIRS-criteria, aiming for a high sensitivity and specificity | Diagnostic test | PICU-Patients |
Primary outcome
Sensitivity and specificity of CDSS compared to Goldstandard
Time frame: 8 months
Assessment of sensitivity and specificity of a CDSS compared to Goldstandard established by two independed blinded paediatric intensivists, the analysis will be done with Wald-Confidence interval and comparison of the lower limit of the confidence interval with the defined range of the null hypothesis.
2 secondary outcomes
Sensitivity and specificity of CDSS on daily level
Time frame: 8 months
Comparison of CDSS with assessment of MDs taking care of the patients
Time frame: 10 months
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 14 Aug 2019.
- Derived from this study: PubMed 33602206Wulff A, Montag S, Rubsamen N, Dziuba F, Marschollek M, Beerbaum P, Karch A, Jack T. Clinical evaluation of an interoperable clinical decision-support system for the detection of systemic inflammatory response syndrome in critically ill children. BMC Med Inform Decis Mak. 2021 Feb 18;21(1):62. doi: 10.1186/s12911-021-01428-7.
- Derived from this study: PubMed 31221891Wulff A, Montag S, Steiner B, Marschollek M, Beerbaum P, Karch A, Jack T. CADDIE2-evaluation of a clinical decision-support system for early detection of systemic inflammatory response syndrome in paediatric intensive care: study protocol for a diagnostic study. BMJ Open. 2019 Jun 19;9(6):e028953. doi: 10.1136/bmjopen-2019-028953.
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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.
Michael Marschollek, PhD study chair
Hannover Medical School
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 SIRS and Sepsis, run by Hannover Medical School at 1 site in Germany.
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 1 inclusion and 1 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 14 Aug 2019. 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 Germany. 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?
Sensitivity and specificity of CDSS compared to Goldstandard (time frame: 8 months). 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 NCT03661450, which also lists 2 linked publications.
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 14 Aug 2019.