NCT03661450 (CADDIE2) is a clinical trial of Clinical Decision-Support System in SIRS, sponsored by Hannover Medical School.

Who is sponsoring NCT03661450?

NCT03661450 is sponsored by Hannover Medical School.

What drugs are being tested in NCT03661450?

Interventions in NCT03661450: Clinical Decision-Support System.

What condition does NCT03661450 study?

NCT03661450 studies SIRS, Sepsis, Pediatric SIRS.

Is NCT03661450 still recruiting?

NCT03661450 is currently completed. Last updated 14 August 2019.

Last reviewed 2019-08-14 · How we verify

NCT03661450: CADDIE2

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Last updated 14 August 2019

What this trial tests

trial testing Clinical Decision-Support System in SIRS in 177 participants. Completed in 31 March 2019.

Timeline

1 August 2018

Primary endpoint
31 March 2019

31 March 2019

Quick facts

Lead sponsor	Hannover Medical School
Status	Completed
Study type	OBSERVATIONAL
Enrollment	177
Start date	1 August 2018
Primary completion	31 March 2019
Estimated completion	31 March 2019
Sites	1 location across Germany

Drugs / interventions tested

Clinical Decision-Support System

Conditions studied

SIRS — all drugs for SIRS →
Sepsis — all drugs for Sepsis →
Pediatric SIRS — all drugs for Pediatric SIRS →

Sponsor

Hannover Medical School

Who can join

Under 18, any sex, with SIRS or Sepsis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

Evidence-based Clinical Decision Support Systems for the prediction and detection of three disease states in critical care: A systematic literature review.
Medic G, Kosaner Kließ M, Atallah L, Weichert J, et al · · 2019 · cited 20× · PMID 31824670 · DOI 10.12688/f1000research.20498.2
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.
Wulff A, Montag S, Steiner B, Marschollek M, et al · · 2019 · cited 7× · PMID 31221891 · DOI 10.1136/bmjopen-2019-028953
Clinical evaluation of an interoperable clinical decision-support system for the detection of systemic inflammatory response syndrome in critically ill children.
Wulff A, Montag S, Rübsamen N, Dziuba F, et al · · 2021 · cited 5× · PMID 33602206 · DOI 10.1186/s12911-021-01428-7
Prediction models for SIRS, sepsis and associated organ dysfunctions in paediatric intensive care: study protocol for a diagnostic test accuracy study.
Böhnke J, Rübsamen N, Mast M, Rathert H, et al · · 2022 · cited 1× · PMID 36645795 · DOI 10.1136/bmjpo-2022-001618

Verify or expand the search:

Other recruiting trials for SIRS

Currently open trials in the same condition.

NCT05591924 — Early Severe Illness TrAnslational BioLogy InformaticS in Humans · recruiting

Other Hannover Medical School trials

Trials by the same sponsor.

NCT07384039 — Exercise Training in Patients With Myeloproliferative Neoplasms · NA · not yet recruiting
NCT06740747 — Intermittent Theta-Burst Stimulation to Improve Negative Symptoms and Cognition in Schizophrenia · NA · recruiting
NCT06795516 — Observational Study on the Clinical Use of ex Vivo Lung Perfusion (XPS™) for Lung Transplantation · terminated
NCT06603311 — Finite Treatment of Hepatitis Delta With Bulevirtide: Identification of Biomarkers Associated With Sustained Control of · NA · active not recruiting
NCT06493006 — Promoting Sustainable and Active Mobility Among Employees and Students · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03661450 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Hannover Medical School
Last refreshed: 14 August 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03661450.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing