Secondary Peritonitis After Intestinal Perforation Clinical Trial
Official title:
Procalcitonin Ratio's Impact on the Decision Upon On-demand Relaparotomy in Septic Peritonitis
| Verified date | January 2013 |
| Source | CHIR-Net |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Ethics Commission: TUM |
| Study type | Observational |
Procalcitonin (PCT) serum levels are monitored in patients with secondary peritonitis after initial operative focus elimination to investigate the PCT ratio's impact on decision-making for or against early relaparotomy in the on-demand relaparotomy concept of secondary septic peritonitis.
| Status | Completed |
| Enrollment | 234 |
| Est. completion date | December 2012 |
| Est. primary completion date | December 2011 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - age >18 years - necessity for operative intervention to eliminate an infectious peritoneal / abdominal focus after organ perforation - abdominal sepsis according to the American College of Chest Physicians/Society of Critical Care Medicine Consensus Conference definition Exclusion Criteria: - pregnancy - immunosuppressive medication |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Germany | Klinikum rechts der Isar der TU München | Munich |
| Lead Sponsor | Collaborator |
|---|---|
| CHIR-Net |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | prediction of focus elimination: cured patients versus patients with persisting peritonitis (definitions see below) | definition of 'focus elimination': patients with intestinal perforation or anastomotic leakage develop (local) peritonitis and consecutive abdominal sepsis. These patients need surgical intervention for focus elimination. This operative intervention aims to eradicate all infectious material and is intended to remove the leaking intestinal lesion. Whether this focus is eliminated or not can be controlled by either planned relaparotomy (normally within 48h after the first operation) or on demand relaparotomy in case of clinical deterioration. The focus can be assumed to be eliminated in all cases where either relaparotomy reveals no ongoing infection or persisting focus and whenever a patient recovers rapidly after initial surgery. | participants will be followed for the duration of hospital stay, an expected average of 21 days | No |