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Physiologic Indicators for Prognosis in Abdominal Sepsis Study

Physiologic Indicators for Prognosis in Abdominal Sepsis (PIPAS) Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03408600
Acronym
PIPAS
Enrollment
4000
Registered
2018-01-24
Start date
2018-02-01
Completion date
2018-05-31
Last updated
2018-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdominal Sepsis, Acute Peritonitis

Keywords

Abdominal sepsis, Secondary peritonitis, Complicated intra-abdominal infections

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

Interventions

OTHERManagement

To evaluate vital signs in a global cohort of patients with acute peritonitis, determining which parameters are statistically significant to predict in-hospital mortality and ICU admission.

Sponsors

World Society of Emergency Surgery
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL

Inclusion criteria

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

Exclusion criteria

\- Clinical diagnosis of acute pancreatitis

Design outcomes

Primary

MeasureTime frameDescription
Hearth rate predicting mortality in patients with acute secondary peritonitis at admission24 weeksHearth rate (bpm);
Respiratory rate predicting mortality in patients with acute secondary peritonitis at admission24 weeksRespiratory rate (breaths/min);
Blood oxygen saturation level predicting mortality in patients with acute secondary peritonitis at admission24 weeksBlood oxygen saturation level (SpO2) (%) in air
Core temperature predicting mortality in patients with acute secondary peritonitis at admission24 weeksCore temperature (°C);
Systolic blood pressure predicting mortality in patients with acute secondary peritonitis at admission24 weeksSystolic blood pressure (mmHg);
Responsiveness predicting mortality in patients with acute secondary peritonitis at admission24 weeksAlert/verbal/painful/unresponsive (AVPU) responsiveness scale;

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026