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NCT Number: NCT03408600

Physiologic Indicators for Prognosis in Abdominal Sepsis 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.

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Key information

Conditions

Acute Peritonitis Abdominal Sepsis Digestive System Diseases Infections Intraabdominal Infections Peritoneal Diseases Peritonitis

Sex eligibility

All sexes

Study type

Observational

Primary location

WSES

Bologna, 40139, Italy

About this study

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

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Clinical diagnosis of acute pancreatitis

Treatment and study plan

Management

Other

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.

Primary outcomes

  1. Respiratory rate predicting mortality in patients with acute secondary peritonitis at admission

    Time frame: 24 weeks

    Respiratory rate (breaths/min);

  2. Blood oxygen saturation level predicting mortality in patients with acute secondary peritonitis at admission

    Time frame: 24 weeks

    Blood oxygen saturation level (SpO2) (%) in air

  3. Core temperature predicting mortality in patients with acute secondary peritonitis at admission

    Time frame: 24 weeks

    Core temperature (°C);

  4. Systolic blood pressure predicting mortality in patients with acute secondary peritonitis at admission

    Time frame: 24 weeks

    Systolic blood pressure (mmHg);

  5. Hearth rate predicting mortality in patients with acute secondary peritonitis at admission

    Time frame: 24 weeks

    Hearth rate (bpm);

  6. Responsiveness predicting mortality in patients with acute secondary peritonitis at admission

    Time frame: 24 weeks

    Alert/verbal/painful/unresponsive (AVPU) responsiveness scale;

Sponsors and collaborators

Lead sponsor

World Society of Emergency Surgery

Other

Registry information

Official study title

Physiologic Indicators for Prognosis in Abdominal Sepsis (PIPAS) Study

Acronym: PIPAS

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jan 24, 2018
Registry last updated
Sep 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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