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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01768936

Enrollment

234

Registered

2013-01-16

Start date

2009-01-31

Completion date

2012-12-31

Last updated

2013-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Secondary Peritonitis After Intestinal Perforation

Keywords

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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Germany

Outcome results