Improve Management of Heart Failure With Procalcitonin

NCT02392689 | Terminated DMC

• 1 other identifier: IMPACT-EU
• Study Type: interventional
• Target: 759
• Locations: 4 countries
• Sites: 15

Brief Summary

Patients presenting to the Emergency Department with shortness of breath and (suspected) heart failure will be screened and randomized to either a standard of care or a procalcitonin-guided arm. Procalcitonin-guided arm: a procalcitonin level (cutoff 0.2 ng/ml) will be used to support decision on antibiotic therapy initiation. Standard of care arm: the decision on antibiotic therapy will be based on the physicians intent to treat. The patients will be followed up 30 and 90 days after randomization to evaluate the survival status, re-hospitalizations and further antibiotic therapies.

Conditions

Heart Failure; Infection

Keywords

procalcitonin; biomarker; antibiotic therapy; emergency department; cardiology; in vitro diagnostics

Outcome Measures

Primary Outcomes (1)

• all cause mortality

  90 days

Secondary Outcomes (3)

• all cause mortality

  30 days

• all-cause hospital readmission

  30 days

• Number of patients with diagnosis of pneumonia during index hospitalization

  participants will be followed for the duration of hospital stay, an expected average of 1 week

Study Arms (2)

PCT-guided

EXPERIMENTAL

Blood samples are taken on day 0 and day 1 of the study. Procalcitonin (PCT) is measured and used support the decision on antibiotic therapy. PCT levels above 0.2 ng/ml: antibiotic therapy is recommended PCT levels equal/below 0.2 ng/ml: antibiotic therapy is not recommended

Other: Procalcitonin

Standard of Care

NO INTERVENTION

Blood samples are taken on day 0 and day 1 and stored for later analysis. The investigator treats the patients according to standard of care.

Interventions

Procalcitonin OTHER

Procalcitonin guided antibiotic therapy

PCT-guided

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who present to the emergency department (ED) with leading symptom dyspnea
• Suspected or known heart failure
• midregional pro atrial natriuretic peptide (MR-proANP)\>300 pmol/L, brain natriuretic peptid (BNP) \>350 ng/ml or N-terminal of the prohormone brain natriuretic peptide (NT-proBNP)\>1800 ng/l
• Patient has given written Informed Consent within study timelines to allow antibiotic therapy within 8 hours
• Adult patients (i.e. \>18 years of age)
• Hospitalization for at least 1 overnight stay planned

You may not qualify if:

• Patient participates in any other interventional clinical trial
• Trauma related shortness of breath
• Patient diagnosed with lung or thyroid cancer
• Known terminal disease with life expectancy of less than 6 months, e.g. advanced metastasized cancer disease
• Organ transplant requiring immunosuppression
• Abdominal, vascular or thorax surgery within the last 30 days
• End stage/advanced heart failure - defined by planned heart transplantation, or cardiogenic shock
• Female patients who have given birth within 3 months before study enrolment
• Current use of antibiotics or requirement of immediate antibiotic therapy before randomization and measurement of Procalcitonin
• End stage renal failure requiring dialysis
• Patient is not willing, or it is not possible or advisable for the patient, to follow the study schedule, including antibiotic therapy and 90 days follow up
• Patient has already participated in the clinical trial previously
• Pregnant or lactating women
• Patients who are institutionalized by official or judicial order
• Dependants of the sponsor, the contract research organization (CRO), the study site or the investigator

Sponsors & Collaborators

• Brahms AG: lead

Study Sites (15)

Aalborg Sygehus

Aalborg, 9000, Denmark

Location

Herlev Hospital

Herlev, 2730, Denmark

Location

Odense University Hospital

Odense, 5000, Denmark

Location

Kerckhoff-Klinik

Bad Nauheim, 61231, Germany

Location

Charite Universitätsmedizin Berlin - CCM

Berlin, 10117, Germany

Location

Charite Universitätmedizin Berlin - CVK

Berlin, 13353, Germany

Location

Universitätsklinikum Frankfurt

Frankfurt am Main, 60596, Germany

Location

Klinikum Frankfurt Höchst GmbH

Frankfurt am Main, 65929, Germany

Location

Universitätsmedizin Göttingen

Göttingen, 37075, Germany

Location

Medizinische Universitätsklinik Heidelberg - Medizinische Klinik III

Heidelberg, 69120, Germany

Location

Universitäres Herzzentrum Lübeck

Lübeck, 23538, Germany

Location

Klinikum Nürnberg Nord

Nuremberg, 90419, Germany

Location

University Medical Center Groningen

Groningen, 9713, Netherlands

Location

Maastricht UMC+

Maastricht, 6229, Netherlands

Location

Hospital Clinico San Carlos

Madrid, 28040, Spain

Location

MeSH Terms

Conditions

Heart Failure; Infections; Emergencies

Interventions

Procalcitonin

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Calcitonin; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Protein Precursors; Proteins

Study Officials

• Alan Maisel, MD

  University of California-San Diego/VA San Diego Healthcare System

  PRINCIPAL INVESTIGATOR

• Martin Möckel, MD

  university hospital Charitè Berlin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2015
• First Posted: March 19, 2015
• Study Start: March 1, 2015
• Primary Completion: April 5, 2018
• Study Completion: April 14, 2018
• Last Updated: July 23, 2018

Record last verified: 2018-07

Locations

DE (9); DK (3); NL (2); ES (1)