Procalcitonin Ratio's Impact on the Decision Upon On-demand Relaparotomy in Septic Peritonitis

Completed

• Conditions: Secondary Peritonitis After Intestinal Perforation

• Registration Number: NCT01768936
• Lead Sponsor: CHIR-Net

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Primary Completion: 2011-12
• Study Completion: 2012-12
• Status Verified: 2013-01
• Study First Submitted: 2013-01-10
• Study First Submitted QC: 2013-01-15
• Last Update Submitted: 2013-01-15
• Study First Posted: 2013-01-16
• Last Update Posted: 2013-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 234

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
prediction of focus elimination: cured patients versus patients with persisting peritonitis (definitions see below)	participants will be followed for the duration of hospital stay, an expected average of 21 days	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.

Trial Locations

Locations (1)

Klinikum rechts der Isar der TU München; 🇩🇪 Munich, Germany