Physiologic Indicators for Prognosis in Abdominal Sepsis Study

Completed

• Conditions: Acute Peritonitis; Abdominal Sepsis

• Registration Number: NCT03408600
• Lead Sponsor: World Society of Emergency Surgery

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

Study Timeline

• Status Verified: 2018-01
• Study First Submitted: 2018-01-05
• Study First Submitted QC: 2018-01-17
• Study First Posted: 2018-01-24
• Study Start: 2018-02-01
• Primary Completion: 2018-05-01
• Study Completion: 2018-05-31
• Last Update Submitted: 2018-09-17
• Last Update Posted: 2018-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4000

Inclusion Criteria

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

Exclusion Criteria

• Clinical diagnosis of acute pancreatitis

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

WSES; 🇮🇹 Bologna, Italy