Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Observational [Patient Registry]|
|Eligible Ages||18 Years and Over|
Inclusion Criteria, at least one of the following:
- - Triaged as one of highest two triage categories (red or orange) according to the Manchester triage system; - Triaged as the third highest triage category (yellow) and arrival by EMS of Helicopter Emergency Medical Service (HEMS; - Shock.
- - Suspicion of sepsis (based on either physicians' suspicion, Sepsis-2 or Sepsis-3 criteria) - Acute kidney injury (AKI) - Anaphylactic reaction.
- - Syncope.
- - Intoxication.
- - Thrombosis.
- - Pulmonary embolism.
- - Bleeding while using anti-coagulant drugs.
- - Gastro-intestinal bleeding.
- - Electrolyte disturbance.
- - Referred for organ transplantation as recipient.
- - Transfer from other hospital.
- - Accidental contact patient material (i.e. internal work-related accident) While data- and imaging will be collected from all these patients, biomaterials will only be collected from patients fulfilling the first criterion (i.e. triaged as one of highest two triage categories [red or orange] according to the Manchester triage system) and from patients with shock or a suspicion of sepsis.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Ewoud ter Avest, MD, PhDJan ter Maaten, MD, PhDBarbara van Munster, MD, PhDHjalmar Bouma, MD, PhD|
|Principal Investigator Affiliation||University Medical Center GroningenUniversity Medical Center GroningenUniversity Medical Center GroningenUniversity Medical Center Groningen|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Acute Disease, Sepsis, Pneumonia, Frailty, Complication of Treatment, Pulmonary Embolism, Thrombosis, Acute Kidney Injury, Electrolyte Disturbance, Hemorrhage, Shock, Polypharmacy, Intoxication by Drug, Emergencies, Urinary Tract Infections, Skin Infection, Syncope, Anaphylaxis, Dyspnea|
|Study Website:||View Trial Website|
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.
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.