Pancreatitis
Conditions
Brief summary
To measure meropenem pancreatic tissue penetration in subjects with severe pancreatitis requiring surgery between 30 to 60 minutes after a bolus of 1 g IV meropenem given during the induction period of anesthesia.
Interventions
DRUGMeropenem
Sponsors
Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Subjects with diagnosis of severe pancreatitis requiring surgery according to the protocol of each Institution. * Informed consent signed by the subject * Subjects who have received prophylactic antibiotics for previous invasive procedures different from surgery may be included
Exclusion criteria
* Will of the subject not to be included * Subjects who have not signed the informed consent * Subjects with known hypersensibility to carbapenems, penicillins, or cephalosporins
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To measure meropenem pancreatic tissue penetration in subjects with severe pancreatitis requiring surgery between 30 and 60 minutes after a bolus of 1 g IV meropenem applied during induction of anesthesia. | — |
Secondary
| Measure | Time frame |
|---|---|
| To describe the incidence of infectious complications during the first 30 days after surgery in subjects with severe pancreatitis receiving IV meropenem at a dose of 1 g every 8 hours during 14 days. | — |
Countries
Colombia
Outcome results
None listed