Abdominal Sepsis Clinical Trial
Official title:
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.
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
;
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