Physiologic Indicators for Prognosis in Abdominal Sepsis Study

Abdominal Sepsis Clinical Trial

— PIPAS  

Official title:

Physiologic Indicators for Prognosis in Abdominal Sepsis (PIPAS) Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03408600
• Other study ID #: WSES/4
• Status: Completed
• Start date: February 1, 2018
• Est. completion date: May 31, 2018

Study information

• Verified date: January 2018
• Source: World Society of Emergency Surgery
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4000
• Est. completion date: May 31, 2018
• Est. primary completion date: May 1, 2018
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Clinical diagnosis of acute pancreatitis

Related Conditions & MeSH terms

• Abdominal Sepsis
• Acute Peritonitis
• Peritonitis
• Sepsis
• Toxemia

Intervention

Other:
• Management
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.

Locations

Country	Name	City	State
Italy	WSES	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
World Society of Emergency Surgery

Country where clinical trial is conducted

Italy, 

Outcome

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