Clinical trial NCT03408600: Physiologic Indicators for Prognosis in Abdominal Sepsis Study
Official title: Physiologic Indicators for Prognosis in Abdominal Sepsis (PIPAS) Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Peritonitis
Abdominal Sepsis
Keywords: Abdominal sepsis
Secondary peritonitis
Complicated intra-abdominal infections
Lead sponsor: World Society of Emergency Surgery
Sponsor class: OTHER
First posted: 2018-01-24
Enrollment: 4000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients admitted to surgical departments with acute secondary peritonitis

Brief summary: Early detection and timely therapeutic intervention can improve the prognosis of patients with sepsis. However, early diagnosis of sepsis can be difficult; because determining which patients presenting with signs of infection during an initial evaluation, do currently have, or will later develop a more serious illness is not easy.

Physiological deterioration often precedes clinical deterioration as patients develop critical illness. In this study, the investigators aim to evaluate vital signs in a global cohort of patients with acute secondary peritonitis, determining which parameters are statistically significant to predict in-hospital mortality and ICU admission.

Detailed description: The study will be a worldwide multicenter observational study. The study will include patients admitted in the surgical department with acute peritonitis during a four-month study period (February 1, 2018 - May 31, 2018).

The study will not attempt to change or modify the clinical practice of the participating physicians: neither informed consent or formal approval by local Ethics Committee will be required because of the purely observational nature of the study.

The study will be monitored by the principal investigator, which will investigate and verify missing or unclear data submitted to a central database.

The study protocol has been approved by the board of the WSES and the study will be conducted under its supervision. The board of the WSES grants the proper ethical conduct of the study.

The data collection will be anonymous, as well as the name of the patients or hospital will be not collected in the website. Every hospital will continue following their ethical standards and local rules. The list of the submitted cases will not be recognized by investigators and linked to the submitting hospital. Individual researchers will take personal responsibility of data collection of this study.

In each center, the coordinator will collect and fill the data in an online case report system. These data included the following:

* Patient and disease characteristics
* Diagnostic profiles
* Treatment profiles
* Post-operative course

Eligibility criteria: Inclusion Criteria:

- Clinical diagnosis of acute (secondary) localized or diffuse peritonitis.

Exclusion Criteria:

- Clinical diagnosis of acute pancreatitis

Primary outcomes:
measure: Respiratory rate predicting mortality in patients with acute secondary peritonitis at admission
timeFrame: 24 weeks
measure: Blood oxygen saturation level predicting mortality in patients with acute secondary peritonitis at admission
timeFrame: 24 weeks
measure: Core temperature predicting mortality in patients with acute secondary peritonitis at admission
timeFrame: 24 weeks
measure: Systolic blood pressure predicting mortality in patients with acute secondary peritonitis at admission
timeFrame: 24 weeks
measure: Hearth rate predicting mortality in patients with acute secondary peritonitis at admission
timeFrame: 24 weeks
measure: Responsiveness predicting mortality in patients with acute secondary peritonitis at admission
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: WSES
Study officials:
References: