Intra-abdominal Abscess
Conditions
Keywords
intra-abdominal, abscess, tPA, alteplase, cathflo
Brief summary
The objective of this study is to establish the efficacy of tPA when used in pediatric intra-abdominal abscesses immediately after percutaneous drainage, irrespective of the ultrasound appearance or consistency of the drained fluid.
Detailed description
The use of tPA in pediatric abdominal abscesses is poorly defined. The indications are somewhat subjective and the dosage guidelines vary between institutions. Some studies have suggested that it be administered at, or soon after, the time of drainage if the ultrasound appearance of the collection is complex and/or septated, or if the initial aspirated contents are thick and viscous. Both criteria are difficult to accurately define and implement. In many instances, when there is minimal ongoing drainage despite follow-up ultrasound appearances suggesting a significant residual collection, tPA is administered several days following the initial procedure. The purpose of this study is to establish the efficacy of tPA in the initial treatment of all pediatric intra-abdominal abcesses and a standardized manner in which it can be used. This may eventually lead to a change in practice in the management of this patient population.
Interventions
DRUGCathflo (Alteplase)
DRUGSaline
Sponsors
The Hospital for Sick Children
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
Inclusion criteria
1. All patients under the age of 18 years with intra-abdominal bacterial abscesses requiring percutaneous drain insertion (including transrectal drains). 2. Drain(s) must be inserted within the 23hrs prior to enrollment in the study. 3. The underlying diagnosis of the condition will not affect the enrollment of the patient unless it is detailed within the
Exclusion criteria
(section 4.1.2). 4. Patients and parents must have signed informed consent to participate in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Length of time the drain remains insitu | up to 2 weeks | The primary outcome is the length of time (in hours) the drain remains insitu. For the primary outcome the individual abscess will be the unit of measurement; if there are multiple abscesses (up to a maximum of three) in the one patient each abscess will receive the same treatment. In the case of more than one drain being inserted in a single patient, the length of time that each drain remains in situ will be recorded individually. |
Secondary
| Measure | Time frame |
|---|---|
| Documentation of any adverse event | up to 2 weeks |
| The length of hospital stay | up to 2 months |
| Rate of resolution of abscess | up to 2 weeks |
| Return of clinical parameters to normal | up to 2 weeks |
Countries
Canada
Outcome results
None listed