NCT03408600

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 5, 2018

Completed
19 days until next milestone

First Posted

Study publicly available on registry

January 24, 2018

Completed
8 days until next milestone

Study Start

First participant enrolled

February 1, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2018

Completed
Last Updated

September 18, 2018

Status Verified

January 1, 2018

Enrollment Period

3 months

First QC Date

January 5, 2018

Last Update Submit

September 17, 2018

Conditions

Acute PeritonitisAbdominal Sepsis

Keywords

Abdominal sepsisSecondary peritonitisComplicated intra-abdominal infections

Outcome Measures

Primary Outcomes (6)

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

    Respiratory rate (breaths/min);

    24 weeks

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

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

    24 weeks

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

    Core temperature (°C);

    24 weeks

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

    Systolic blood pressure (mmHg);

    24 weeks

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

    Hearth rate (bpm);

    24 weeks

  • Responsiveness predicting mortality in patients with acute secondary peritonitis at admission

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

    24 weeks

Interventions

ManagementOTHER

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.

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients admitted to surgical departments with acute secondary peritonitis

You may qualify if:

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

You may not qualify if:

  • \- Clinical diagnosis of acute pancreatitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

WSES

Bologna, 40139, Italy

Location

MeSH Terms

Conditions

Intraabdominal InfectionsPeritonitis

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

InfectionsPeritoneal DiseasesDigestive System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

January 5, 2018

First Posted

January 24, 2018

Study Start

February 1, 2018

Primary Completion

May 1, 2018

Study Completion

May 31, 2018

Last Updated

September 18, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will share

Locations

IT(1)