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

Sepsis Clinical Trial

— Acutelines  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04615065
• Other study ID #: 201900635
• Status: Recruiting
• Start date: September 1, 2020
• Est. completion date: September 1, 2030

Study information

• Verified date: June 2024
• Source: University Medical Center Groningen
• Contact: Hjalmar Bouma, MD, PhD
• Phone: +31 50 361 6161
• Email: acutelines[@]umcg.nl
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

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.

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])

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35000
• Est. completion date: September 1, 2030
• Est. primary completion date: September 1, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Exclusion Criteria:

• 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.

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

Locations

Country	Name	City	State
Netherlands	University Medical Center Groningen	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality (time and cause)	Mortality will be retrieved from the electronic health records (EHR) from the hospital and municipal registration. The cause of death will be retrieved from the EHR from the hospital, general practitioner and Dutch statistics' office (CBS).	Until the death of death from any cause, up to 50 years
Primary	Katz ADL-6 (functioning)	Katz ADL-6 (0-6, fully dependent-independent)	Up to 1 year
Primary	World Health Organization (WHO) performance status (functioning)	World Health Organization (WHO) performance status (0-4, normal performance-bedridden)	Up to 1 year
Primary	Karnofsky performance score (functioning)	Karnofsky performance score (10-100, moribund-normal performance)	Up to 1 year
Primary	Utrecht Activity List (daily activities)	Utrecht Activity List (UAL; hours/week spend on (a) paid work, (b) education, (c) household, (d) running errands, (e) unpaid work, (f) sport, (g) hobbies, (h) other use of leisure time )	Up to 1 year
Primary	Short QUestionnaire to ASsess Health-enhancing physical activity (daily activities)	Short QUestionnaire to ASsess Health-enhancing physical activity (SQUASH; minutes/week and intensity of activity spend (a) commuting, (b) at work, (c) household activities and (d) leisure time; increased score corresponds with increased physical activity)	Up to 1 year
Primary	Quality of Life and experienced symptoms	EuroQol-5D (EQ5D; simple descriptive profile and a single index value for health status; higher values corresponding with better health) with visual analogue scale (VAS; 0-100, worse-best experienced health)	Up to 1 year
Primary	Experienced somatic symptoms	Patient Health Questionnaire-15 (PHQ-15; 0-30, minimal-high somatic symptom severity)	Up to 1 year
Primary	Fatigue	Piper Fatigue Scale-12 (PFS-12; 0-10, higher scores reflect more fatigue among four subscales (a) behavior, (b) affect, (c) sensory, (d) cognition)	Up to 1 year
Primary	Patient Health Questionnaire-2 (mental health)	Patient Health Questionnaire-2 (PHQ-2; 0-6, higher score corresponds to reduced mental health)	Up to 1 year
Primary	Patient Health Questionnaire-9 (mental health)	Patient Health Questionnaire-9 (PHQ-9; 0-4 no depressive symptoms, 5-9 mild depressive symptoms, 10-14 moderate depressive symptoms, 15-19 moderately severe depressive symptoms, 20-27 severe depressive symptoms)	Up to 1 year
Primary	Geriatric Depression scale-15 (mental health)	Geriatric Depression scale-15 (GDS-15; 0-4 no depressive symptoms, 5-10 mild depressive symptoms, 11-15 depressive symptoms)	Up to 1 year
Primary	Patient satisfaction	Patient Satisfaction Questionnaire Short-form (PSQ-18; measuring general satisfaction, technical quality, interpersonal manner, communication, financial aspects, time spent with doctor, and accessibility and convenience; scored per domain, with lower scores corresponding with higher satisfaction)	Up to 1 year
Primary	Decision making	Outcome prioritization tool (OPT; 0-100% per domain of prioritization for (a) life extension, (b) preserving independence, (c) reducing pain and (d) reducing other symptoms)	Up to 1 year
Primary	Co-morbidity	Co-morbidity will be retrieved from the electronic health records (EHR) from the hospital, general practitioner and pharmacy. Data will be registered according to the Charlson' co-morbidity index (CCI; 1-2 mild co-morbidity, 3-4 moderate co-morbidity, 5 severe co-morbidity)	Up to 5 years
Primary	Length-of-stay in hospital/intensive care unit (ICU)	Length-of-stay in hospital and on intensive care unit (ICU) in days	Until hospital discharge, an average of 2 weeks
Secondary	Biomarkers	Laboratory values (Hb [mmol/L], leukocytes [/mL), trombocytes [/ml], creatinine [mmol/L], urea [mmol/L], CRP [mg/L], LDL cholesterol [mmol/L], HDL cholesterol [mmol/L], total cholesterol [mmol/L], AST [U/L], ALT [U/L], gGT [U/L], AF [U/L], bilirubin [microl/L], NTproBNP [pg/mL], troponin [microg/L]) will be retrieved from the electronic health records (EHR) from the hospital, general practitioner and pharmacy.	Up to 5 years
Secondary	Medication use	Medication use will be retrieved from the electronic health records (EHR) from the hospital, general practitioner and pharmacy.	Up to 5 years
Secondary	Treatment (non-pharmacological, including organ support)	Treatment (non-pharmacological) will be retrieved from the electronic health records (EHR) from the hospital, general practitioner and (helicopter) emergency medical service. Data will include intravenous fluid resuscitation, vasopressors, mechanical ventilation/non-invasive ventilation, oxygen supply, acute dialysis and extra-corporeal membrane oxygenation (ECMO)	Until hospital discharge, up to 3 months
Secondary	Sequential organ failure assessment (SOFA)	SOFA scores will be available for patients admitted because of an infection.	Up to 72 hours after hospitalization
Secondary	Vital parameters	Heart rate (bpm), blood pressure (mmHg), oxygen saturation (SpO2, SaO2, PaO2), breathing frequency (per min), consciousness (Glasgow coma scale), pain score (VAS), nausea/vomiting (y/n), defecation (y/n), urination (y/n), body weight (kg), length (cm), fluid balance (ml/day).	Until hospital discharge, up to 3 months