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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01768936
Recruitment Status : Completed
First Posted : January 16, 2013
Last Update Posted : January 16, 2013
Information provided by (Responsible Party):

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.

Condition or disease
Secondary Peritonitis After Intestinal Perforation

Study Type : Observational
Actual Enrollment : 234 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Procalcitonin Ratio's Impact on the Decision Upon On-demand Relaparotomy in Septic Peritonitis
Study Start Date : January 2009
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2012

eliminated infectious abdominal focus
persisting/progressing infectious abdominal focus

Primary Outcome Measures :
  1. prediction of focus elimination: cured patients versus patients with persisting peritonitis (definitions see below) [ Time Frame: 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.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01768936

Klinikum rechts der Isar der TU München
Munich, Germany
Sponsors and Collaborators

Responsible Party: CHIR-Net Identifier: NCT01768936     History of Changes
Other Study ID Numbers: TUM-PCT-1
PCTRatio Reevaluation ( Other Identifier: CHIR-Net )
First Posted: January 16, 2013    Key Record Dates
Last Update Posted: January 16, 2013
Last Verified: January 2013

Keywords provided by CHIR-Net:
on-demand relaparotomy
focus index

Additional relevant MeSH terms:
Intestinal Perforation
Intraabdominal Infections
Peritoneal Diseases
Digestive System Diseases
Intestinal Diseases
Gastrointestinal Diseases
Bone Density Conservation Agents
Physiological Effects of Drugs