ClinicalTrials.gg
CompletedNCT01768936Updated Jan 16, 2013

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

An observational study in Secondary Peritonitis After Intestinal Perforation, sponsored by CHIR-Net. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-01-16.

Sponsored by CHIR-Net · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
234
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Secondary Peritonitis After Intestinal Perforation

Keywords

  • on-demand relaparotomy
  • PCT
  • procalcitonin
  • peritonitis
  • sepsis
  • focus index
03

In context

Peritonitis

167 studies on the registry are indexed under Peritonitis; 23 are open to participants now.

This study's enrollment of 234 is above the median of 137 across 55 observational studies indexed under Peritonitis.

Browse Peritonitis studies →

Lead sponsor

CHIR-Net is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • pregnancy
  • medication
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
234 participants (actual)
Patient registry
No

Groups and cohorts

  • eliminated infectious abdominal focus
  • persisting/progressing infectious abdominal focus
06

What researchers measure

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.

    Time frame: participants will be followed for the duration of hospital stay, an expected average of 21 days

07

Study locations

1 site
  • Klinikum rechts der Isar der TU München
    Munich, Germany
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2009, a primary completion of Dec 2011 and a completion of Dec 2012. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 10, 2013
First posted
Jan 16, 2013
Start
Jan 2009
Primary completionActual
Dec 2011
CompletionActual
Dec 2012
Last update
Jan 16, 2013
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 16, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01768936
Lead sponsor
CHIR-Net
Responsible party
Sponsor
First posted
Jan 16, 2013
Start date
Jan 2009
Primary completion
Dec 2011
Completion
Dec 2012
Last update
Jan 16, 2013
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.

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