Evaluation of CDSS in Detection of SIRS and Sepsis in Pediatric Patients

NCT03661450 | Completed DMC

• 1 other identifier: 7804_BO_S_2018
• Study Type: observational
• Target: 177
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

SIRS; Sepsis; Pediatric SIRS

Keywords

Clinical Decision-Support System

Outcome Measures

Primary Outcomes (1)

• 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.

  8 months

Secondary Outcomes (2)

• Sensitivity and specificity of CDSS on daily level

  8 months

• Comparison of CDSS with assessment of MDs taking care of the patients

  10 months

Study Arms (1)

PICU-Patients

Pediatric patients admitted after 01.08.2018

Diagnostic Test: Clinical Decision-Support System

Interventions

Clinical Decision-Support System DIAGNOSTIC_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

PICU-Patients

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

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.

You may qualify if:

• all pediatric patients admitted to our PICU

You may not qualify if:

• patients that are supposed to stay for less than 12 hours on our PICU

Sponsors & Collaborators

• Hannover Medical School: lead
• Technische Universitaet Braunschweig: collaborator
• Helmholtz Centre for Infection Research: collaborator

Study Sites (1)

Hannover Medical School

Hanover, Lower Saxony, 30625, Germany

Location

Related Publications (2)

• 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.

  PMID: 33602206 DERIVED

• Wulff 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.

  PMID: 31221891 DERIVED

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael Marschollek, PhD

  Hannover Medical School

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2018
• First Posted: September 7, 2018
• Study Start: August 1, 2018
• Primary Completion: March 31, 2019
• Study Completion: March 31, 2019
• Last Updated: August 14, 2019

Record last verified: 2019-08

Locations

DE (1)