Physiologic Indicators for Prognosis in Abdominal Sepsis Study (PIPAS)

Physiologic Indicators for Prognosis in Abdominal Sepsis (PIPAS) Study

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.

Study Overview

• Status: Completed
• Conditions: Abdominal Sepsis; Acute Peritonitis
• Intervention / Treatment: Other: Management

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

• Study Type: Observational
• Enrollment (Actual): 4000

Contacts and Locations

Study Locations

• Italy
  • Bologna, Italy, 40139
    • WSES

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All patients admitted to surgical departments with acute secondary peritonitis

Description

Inclusion Criteria:

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

Exclusion Criteria:

- Clinical diagnosis of acute pancreatitis

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiratory rate predicting mortality in patients with acute secondary peritonitis at admission	Respiratory rate (breaths/min);	24 weeks
Blood oxygen saturation level predicting mortality in patients with acute secondary peritonitis at admission	Blood oxygen saturation level (SpO2) (%) in air	24 weeks
Core temperature predicting mortality in patients with acute secondary peritonitis at admission	Core temperature (°C);	24 weeks
Systolic blood pressure predicting mortality in patients with acute secondary peritonitis at admission	Systolic blood pressure (mmHg);	24 weeks
Hearth rate predicting mortality in patients with acute secondary peritonitis at admission	Hearth rate (bpm);	24 weeks
Responsiveness predicting mortality in patients with acute secondary peritonitis at admission	Alert/verbal/painful/unresponsive (AVPU) responsiveness scale;	24 weeks

Collaborators and Investigators

• Sponsor: World Society of Emergency Surgery

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2018
• Primary Completion (Actual): May 1, 2018
• Study Completion (Actual): May 31, 2018

Study Registration Dates

• First Submitted: January 5, 2018
• First Submitted That Met QC Criteria: January 17, 2018
• First Posted (Actual): January 24, 2018

Study Record Updates

• Last Update Posted (Actual): September 18, 2018
• Last Update Submitted That Met QC Criteria: September 17, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Complicated intra-abdominal infections; Abdominal sepsis; Secondary peritonitis
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Peritoneal Diseases; Sepsis; Toxemia; Intraabdominal Infections; Peritonitis
• Other Study ID Numbers: WSES/4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No