Aortic Valve Stenosis
Conditions
Keywords
Aortic Valve Stenosis, Aortic Valve Replacement, Transcatheter Aortic Valve Replacement, Aortic Valve, Cephalosporin, Ampicllin, Bacteremia, Per Procedure Prophylaxis
Brief summary
The study is a prospective, crossover, cluster randomized trial in patients undergoing transcatheter aortic valve implantation (TAVI). The study tests whether cephalosporin plus beta-lactam antibiotic with spectrum for Enterococcus faecalis as per procedural prophylaxis is superior to cephalosporin alone in reducing the composite outcome of bacteremia or death at 6 months post-TAVI.
Detailed description
The PAPPI trial is designed as a prospective, crossover, unblinded, cluster randomized trial. The study includes all TAVI centers in Denmark. Each center will be included for either single dose cephalosporin (1st, 2nd or 3rd generation) plus a beta-lactam antibiotic with spectrum for Enterococcus faecalis (e.g. ampicillin 2g) or single dose of a cephalosporin (1st, 2nd or 3rd generation) as antibiotic prophylaxis in relation to TAVI. The antibiotic(s) will be given as a single dose intravenously per-procedural. Patients will be followed from date of TAVI procedure until 6 months post procedure. The primary outcome of the PAPPI trial will be a composite of the following components within 6 months post TAVI: * Bacteremia (excluding all enterobacterales) * Death Secondary outcomes will be each separate component of the primary outcome and will be ana-lyzed separately as time-to-first event analysis. Additional secondary outcomes will be; * Bacteremia (excluding all enterobacterales) * Acute kidney failure * Death * Length of hospital stay * Days-out-of-hospital from TAVI to 6 months
Interventions
DRUGBeta-lactam antibiotic with spectrum for Enterococcus faecalis
Beta-lactam antibiotic with spectrum for Enterococcus faecalis (e.g. ampicillin 2g) add-on in combination with cephalosporin as per-procedural prophylaxis in TAVI
DRUGCephalosporin
Cephalosporin treatment
Sponsors
Rigshospitalet, Denmark
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Prospective, crossover, cluster-randomized study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All patients \> 18 years of age undergoing TAVI at sites in Denmark
Exclusion criteria
* Patients who do not want to participate and have chosen to "opt-out" of the trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with a composite outcome of bacteremia or death by 6 months. | 6 months post-TAVI | Bacteremia is defined as having positive blood cultures (excluding all enterobacterales) registered in the Danish Microbiological Database at 6 months post-TAVI. Death is defined as being registered as deceased in the Danish Civil Registration System at 6 months post-TAVI. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients who died by 6 months | 6 months post-TAVI | Death is defined as being registered as deceased in the Danish Civil Registration System 6 months post-TAVI. |
| Bacteremia assessed by collection of blood cultures. | 6 months post-TAVI | Bacteremia is defined as having positive blood cultures (excluding all enterobacterales) registered in the Danish Microbiological Database at 6 months post-TAVI. |
| Number of patients with acute kidney failure assessed by plasma creatinine levels. | 6 months post-TAVI | Acute kidney failure is defined as ≥50% increase in the plasma creatinine within 6 months post-TAVI and information on plasma creatinine levels is obtained from the national blood sample data. |
| Length of hospital stay | From the day of TAVI-procedure until the day of discharge after the TAVI-procedure e.g. days from TAVI-procedure until discharge assessed up to 6 months post-TAVI due to end of follow-up. | Length of hospital stay in relation to the TAVI-procedure |
| Days-out-of-hospital from TAVI to 6 months | 6 months post-TAVI | Days-out-of-hospital from TAVI to 6 months |
Countries
Denmark
Contacts
CONTACTEmil L Fosbøl, MD, PhD
Outcome results
None listed