Summary of the study’s registration of the German Clinical Trial Registry
| Item | Description |
| Primary registry and trial identifying no | German clinical trial registry DRKS00029071 |
| Date of registration in primary registry | 23 May 2022 |
| Secondary identifying numbers | Universal Trial Number: U111-1278-2581 |
| German Federal Ministry of Health: ZMVI1-2520DAT66C | |
| Hannover Medical Ethic Committee: 10188_BO_SK_2022 | |
| Source(s) of monetary or material support | Department of Paediatric Cardiology and Paediatric Intensive Care, Hannover Medical School, Germany |
| Primary sponsor | Department of Paediatric Cardiology and Paediatric Intensive Care, Hannover Medical School, Germany |
| Secondary sponsor(s) | German Federal Ministry of Health |
| Contact for public and scientific queries | Department of Paediatric Cardiology and Paediatric Intensive Care, Hannover Medical School, Germany |
| Public and scientific title | A Learning and Interoperable, Smart Clinical Decision Support System for the PICU (ELISE) – preparation work for work package 4: A retrospective evaluation of the predictive model in comparison to the real time assessment of clinicians |
| Countries of recruitment | Germany |
| Health condition(s) or problem(s) to be studied | ICD10: N17.9 – Acute renal failure, unspecified ICD10: K72.0 – Acute and subacute hepatic failure ICD10: J96.0 – Acute respiratory failure ICD10: R57.9 – Shock, unspecified ICD10: D77 – Other disorders of blood and blood-forming organs in diseases classified elsewhere ICD10: R65 – Systemic Inflammatory Response Syndrome ICD10: A41 – Other sepsis |
| Intervention(s) | Index test: Assessment for the presence of SIRS, sepsis and associated organ dysfunctions using predictive models (up to 12 hours prior to disease onset) |
| Reference standard: Assessment for the presence of SIRS, sepsis and associated organ dysfunctions using knowledge-based models | |
| Standard of care: Routine data assessment for the presence of SIRS, sepsis and associated organ dysfunctions performed by clinicians of the study centre in real-time conditions | |
| Key inclusion and exclusion criteria | Inclusion criteria: Children (0–17 years of age) of all sexes who stay at the study centre for at least 12 hours and of whom a written informed consent was issued by the patient’s legal guardians/representatives. |
| Exclusion criteria: All patients who were staying in the PICU for less than 12 hours to the study centre and/or of whom no written informed consent was issued or revoked by the patient’s legal guardians/representatives. | |
| Study type | Non-interventional, diagnostic test accuracy study |
| Allocation: Single arm; Blinding: Open (masking not used); Control: Uncontrolled/Single arm | |
| Primary purpose: Diagnostic | |
| Date of first enrolment | 25 July 2022 |
| Target sample size | 500 |
| Recruitment status | Ongoing |
| Primary outcome(s) | Estimation of sensitivity and specificity of the predictive models to correctly classify the presence of SIRS, sepsis and associated organ dysfunctions |
| Key secondary outcome(s) | Superiority of the diagnostic accuracy of the predictive models in comparison to the real-time evaluation of clinicians |
ICD, International Classification of Diseases; PICU, paediatric intensive care unit; SIRS, systemic inflammatory response syndrome.