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

NCT03661450 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 177

Last updated 2019-08-14

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

Clinical Decision-Support System

Patient Data is evaluated by a Clinical Decision-Support System searching for age-adapted pediatric SIRS-criteria, aiming for a high sensitivity and specificity

Sponsors & Collaborators

  • Technische Universitaet Braunschweig

    collaborator OTHER
  • Helmholtz Centre for Infection Research

    collaborator OTHER
  • Hannover Medical School

    lead OTHER

Principal Investigators

  • Michael Marschollek, PhD · Hannover Medical School

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-08-01
Primary Completion
2019-03-31
Completion
2019-03-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03661450 on ClinicalTrials.gov