Akershus Cardiac Examination 4 Study

N/AActive Not RecruitingNCT05699564

University Hospital, Akershus574 enrolled

Overview

Patients hospitalized with tachypnea, defined as respiratory rate ≥20/ min, have substantial mortality and may suffer from different conditions, including acute heart failure (HF). Symptoms of HF can be difficult to identify and \~15% of patients with HF will not be correctly diagnosed by the treating physician in the Emergency Department. Biomarkers like B-type natriuretic peptides and cardiac troponins improve diagnostic accuracy and risk stratification. Whether early, structured biomarker assessment and structured feedback in the patient's electronic health records improve management and outcomes among unselected patients with tachypnea have previously not been explored in a randomized controlled trial. The main research question of the study is to determine whether early structured biomarker assessment in unselected patients with tachypnea extends the time to the first event for either (1) all-cause readmission or (2) all-cause mortality; i.e. time to the combined endpoint, compared to the current strategy/standard care

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

574

Conditions

Heart Failure Tachypnea

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients ≥18 years old * Tachypnea (respiratory rate ≥20/min) * Admission to Departments under the Division of Medicine at Akershus University Hospital, except the Department of Neurology * \<24 h from hospital admittance to inclusion in the study * Signed written informed consent during the initial phase of the hospitalization Exclusion Criteria: * Previously included into the study (in case of patients presenting with a second hospitalization during the study period) * Known or suspected cancer outside of local control, documented in medical records, at the time of patient inclusion or diagnosed in relation to the index hospitalization * Neurological condition with short life expectancy; e.g. ALS, documented in medical records during screening prior to study entry * Other non-cardiac disease with life expectancy below 1 year, documented in medical records during screening prior to study entry * Obvious non-cardiac cause for tachypnea based on medical records and clinical findings during screening prior to study entry; e.g. anaphylaxis in young patient with known allergy, dyspnea after direct chest trauma, or young patient with fever and positive Covid-19 test on admission. * Patient assessed as non-Internal Medicine patient; e.g. surgical patient * Patients unwilling or unable to comply with the protocol, including Glasgow Coma Scale \<13 on the time of study inclusion * Patients that are intubated for invasive ventilatory therapy before or shortly after hospital admission * History of non-compliance to medical management and patients who are considered potentially unreliable, based on documentation in medical records, during screening prior to study entry * History or evidence of alcohol or drug abuse with the last 12 months, based on medical records and clinical findings during screening prior to study entry, that will influence study participation * Any surgical or medical condition, based on medical records and clinical findings during screening prior to study entry, that will impair the ability of the patient to participate in the study

Outcomes

Primary Outcomes

Composite of all-cause hospital readmission or all-cause mortality

Composite of all-cause hospital readmission or all-cause mortality after discharge from index hospitalization

Time frame: 12 months after discharge from index hospitalization

Secondary Outcomes

Hospital length of stay

Hospital length of stay during the index hospitalization

Time frame: From admission to discharge of index hospitalization, assessed up to 12 months

Length of stay in Intensive Care Unit/Medical Intensive Care Unit/Cardiac Intensive Care Unit

Length of stay in Intensive Care Unit/Medical Intensive Care Unit/Cardiac Intensive Care Unit during the index hospitalization

Time frame: From admission to discharge of index hospitalization, assessed up to 12 months

30-day all-cause readmission

30-day all-cause readmission after discharge from index hospitalization

Time frame: 30-days after discharge from index hospitalization

Time to all-cause readmission

Time to first all-cause readmission after discharge from index hospitalization

Time frame: 12 months after discharge from index hospitalization

Number of all-cause readmission

Number of all-cause readmissions after discharge from index hospitalization

Time frame: 12 months after discharge from index hospitalization

All-cause mortality

Time to all-cause mortality after discharge from index hospitalization

Time frame: 12 months after discharge from index hospitalization

Total cost of hospitalization

Time frame: From admission to discharge of index hospitalization, assessed up to 12 months

All-cause mortality

All-cause mortality during the index hospitalization

Time frame: From admission to discharge of index hospitalization, assessed up to 12 months

Difference in cardiac biomarker concentrations during index hospitalization

Difference in the cardiac troponin T and/or I and B-type natriuretic peptide and/or N-terminal pro-B-type natriuretic peptide concentrations from hospital admission to discharge

Time frame: From admission to discharge of index hospitalization, assessed up to 12 months

Difference in guideline-defined medical therapy for heart failure

Difference in guideline-defined medical therapy for heart failure, as defined by international guidelines, at discharge after index hospitalization

Time frame: From admission to discharge of index hospitalization, assessed up to 12 months

Cost-utility

Cost-utility for the intervention strategy

Time frame: From admission to discharge of index hospitalization, assessed up to 12 months

Akershus Cardiac Examination 4 Study

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes