Acutelines: a Large Data-/Biobank of Acute and Emergency Medicine — Acutelines  

Sepsis Clinical Trial

Official title: Acutelines: a Large Biobank Aiming to Improve Early Recognition of Acute Diseases, Contribute to the Development of Personalized Medicine and Optimize Short- and Long-term Outcome

Status Recruiting

Clinical Trial Summary

Research in acute care faces many challenges, including enrollment challenges, legal limitations in data sharing, limited funding, and lack of singular ownership of the domain of acute care. To overcome some of these challenges, the Center of Acute Care of the University Medical Center Groningen in the Netherlands, has established a de novo data-, image- and biobank named "Acutelines". Acutelines is initiated to improve recognition and treatment of acute diseases and obtain insight in the consequences of acute diseases, including factors predicting its outcome. Thereby, Acutelines contributes to development of personalized treatment and improves prediction of patient outcomes after an acute admission.

Clinical Trial Description

Acutelines is a prospective biobank including patients with a broad spectrum of acute conditions. Its aim is to facilitate interdisciplinary research on the etiology and development of acute diseases with the aid of systematically collected biomaterials and medical data over various timepoints, both during the course of the patient's disease and after recovery. Clinical data, imaging data and biomaterial (i.e. blood, urine, feces, hair) are collected for patients presenting to the Emergency Department (ED) with a broad range of acute disease presentations. A deferred consent procedure (by proxy), is in place to allow collecting data and biomaterials prior to obtaining written consent. The digital infrastructure in place and the software used ensures automated capturing of all bed-side monitoring data (i.e. electrophysiological waveforms, vital parameters), and the secure importation of data from other sources, such as the electronic health records of the hospital, ambulance and general practitioner, municipal registration, health insurance companies and pharmacy. Follow up data are collected for all included patients during the first 72-hours of their hospitalization and 3-months, 1-year, 2-years and 5 years after their ED visit.

Data and materials to be collected includes:

• Demographic and health data (i.e. [experiences] health, quality of life, functional status)

• Medical history (i.e. co-morbidity, intoxications, medication use)

• Admission reason to emergency department

• Physical examination and vital parameters

• Clinical diagnostic data (i.e. [point-of-care] ultrasound, X-ray, CT-scan, laboratory results)

• Electrophysiological waveforms (i.e. electrocardiogram [ECG], plethysmography)

• Biomaterials

• Treatment (i.e. medication use, non-pharmacological treatment, treatment decisions, length-of-stay in hospital, admission to intensive care unit [ICU]) ;

Related Conditions & MeSH terms

• Acute Disease
• Acute Kidney Injury
• Anaphylaxis
• Communicable Diseases
• Complication of Treatment
• Dyspnea
• Electrolyte Disturbance
• Embolism
• Emergencies
• Frailty
• Hemorrhage
• Infections
• Intoxication by Drug
• Pneumonia
• Polypharmacy
• Pulmonary Embolism
• Sepsis
• Shock
• Skin Infection
• Syncope
• Thrombosis
• Urinary Tract Infections

• NCT number: NCT04615065
• Study type: Observational [Patient Registry]
• Source: University Medical Center Groningen
• Contact: Hjalmar Bouma, MD, PhD
• Phone: +31 50 361 6161
• Email: acutelines@umcg.nl
• Status: Recruiting
• Start date: September 1, 2020
• Completion date: September 1, 2030