An observational study in Acute Peritonitis and Abdominal Sepsis, sponsored by World Society of Emergency Surgery. Completed at 1 site in Italy. Per ClinicalTrials.gov, last updated 2018-09-18.
Sponsored by World Society of Emergency Surgery · Observational
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:
All patients admitted to surgical departments with acute secondary peritonitis
Exclusion Criteria:
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.
Respiratory rate predicting mortality in patients with acute secondary peritonitis at admission
Respiratory rate (breaths/min);
Time frame: 24 weeks
Blood oxygen saturation level predicting mortality in patients with acute secondary peritonitis at admission
Blood oxygen saturation level (SpO2) (%) in air
Time frame: 24 weeks
Core temperature predicting mortality in patients with acute secondary peritonitis at admission
Core temperature (°C);
Time frame: 24 weeks
Systolic blood pressure predicting mortality in patients with acute secondary peritonitis at admission
Systolic blood pressure (mmHg);
Time frame: 24 weeks
Hearth rate predicting mortality in patients with acute secondary peritonitis at admission
Hearth rate (bpm);
Time frame: 24 weeks
Responsiveness predicting mortality in patients with acute secondary peritonitis at admission
Alert/verbal/painful/unresponsive (AVPU) responsiveness scale;
Time frame: 24 weeks
Plan to share: Yes
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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World Society of Emergency Surgery