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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CHIR-Net
ClinicalTrials.gov Identifier:
NCT01768936
First received: January 10, 2013
Last updated: January 15, 2013
Last verified: January 2013
  Purpose

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
Secondary Peritonitis After Intestinal Perforation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Procalcitonin Ratio's Impact on the Decision Upon On-demand Relaparotomy in Septic Peritonitis

Further study details as provided by CHIR-Net:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 234
Study Start Date: January 2009
Study Completion Date: December 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
eliminated infectious abdominal focus
persisting/progressing infectious abdominal focus

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01768936

Locations
Germany
Klinikum rechts der Isar der TU München
Munich, Germany
Sponsors and Collaborators
CHIR-Net
  More Information

No publications provided

Responsible Party: CHIR-Net
ClinicalTrials.gov Identifier: NCT01768936     History of Changes
Other Study ID Numbers: TUM-PCT-1, PCTRatio Reevaluation
Study First Received: January 10, 2013
Last Updated: January 15, 2013
Health Authority: Ethics Commission: TUM

Keywords provided by CHIR-Net:
on-demand relaparotomy
PCT
procalcitonin
peritonitis
sepsis
focus index

Additional relevant MeSH terms:
Peritonitis
Intestinal Perforation
Intraabdominal Infections
Infection
Peritoneal Diseases
Digestive System Diseases
Intestinal Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on September 18, 2014