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OpenTrials
Completed

NCT Number: NCT01768936

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

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.

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Key information

Conditions

Secondary Peritonitis After Intestinal Perforation Digestive System Diseases Infections Inflammation Intraabdominal Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Peritoneal Diseases Peritonitis Sepsis Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Klinikum rechts der Isar der TU München

Munich, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

CHIR-Net

Network

Registry information

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
Jan 16, 2013
Registry last updated
Jan 16, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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