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

NCT01768936 | Completed

• 2 other identifiers: TUM-PCT-1PCTRatio Reevaluation
• Study Type: observational
• Target: 234
• Locations: 1 country
• Sites: 1

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.

Conditions

Secondary Peritonitis After Intestinal Perforation

Keywords

on-demand relaparotomy; PCT; procalcitonin; peritonitis; sepsis; focus index

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

eliminated infectious abdominal focus

persisting/progressing infectious abdominal focus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

consecutive postoperative surgical patients on ICU after intestinal perforation or anastomotic leakage with indication for surgical focus elimination

You may qualify if:

• 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

You may not qualify if:

• pregnancy
• immunosuppressive medication

Sponsors & Collaborators

• CHIR-Net: lead

Study Sites (1)

Klinikum rechts der Isar der TU München

Munich, Germany

Location

MeSH Terms

Conditions

Peritonitis; Sepsis

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Peritoneal Diseases; Digestive System Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2013
• First Posted: January 16, 2013
• Study Start: January 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2012
• Last Updated: January 16, 2013

Record last verified: 2013-01

Locations

DE (1)