Ignite Creation Date:
2025-12-26 @ 12:16 PM
Ignite Modification Date:
2025-12-31 @ 12:14 PM
Study NCT ID:
NCT03408600
Status:
COMPLETED
Last Update Posted:
2018-09-18
First Post:
2018-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Physiologic Indicators for Prognosis in Abdominal Sepsis Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059413', 'term': 'Intraabdominal Infections'}, {'id': 'D010538', 'term': 'Peritonitis'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D010532', 'term': 'Peritoneal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2018-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-17', 'studyFirstSubmitDate': '2018-01-05', 'studyFirstSubmitQcDate': '2018-01-17', 'lastUpdatePostDateStruct': {'date': '2018-09-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Respiratory rate predicting mortality in patients with acute secondary peritonitis at admission', 'timeFrame': '24 weeks', 'description': 'Respiratory rate (breaths/min);'}, {'measure': 'Blood oxygen saturation level predicting mortality in patients with acute secondary peritonitis at admission', 'timeFrame': '24 weeks', 'description': 'Blood oxygen saturation level (SpO2) (%) in air'}, {'measure': 'Core temperature predicting mortality in patients with acute secondary peritonitis at admission', 'timeFrame': '24 weeks', 'description': 'Core temperature (°C);'}, {'measure': 'Systolic blood pressure predicting mortality in patients with acute secondary peritonitis at admission', 'timeFrame': '24 weeks', 'description': 'Systolic blood pressure (mmHg);'}, {'measure': 'Hearth rate predicting mortality in patients with acute secondary peritonitis at admission', 'timeFrame': '24 weeks', 'description': 'Hearth rate (bpm);'}, {'measure': 'Responsiveness predicting mortality in patients with acute secondary peritonitis at admission', 'timeFrame': '24 weeks', 'description': 'Alert/verbal/painful/unresponsive (AVPU) responsiveness scale;'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Abdominal sepsis', 'Secondary peritonitis', 'Complicated intra-abdominal infections'], 'conditions': ['Acute Peritonitis', 'Abdominal Sepsis']}, 'descriptionModule': {'briefSummary': '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.\n\nPhysiological 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.', 'detailedDescription': '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).\n\nThe 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.\n\nThe study will be monitored by the principal investigator, which will investigate and verify missing or unclear data submitted to a central database.\n\nThe 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.\n\nThe 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.\n\nIn each center, the coordinator will collect and fill the data in an online case report system. These data included the following:\n\n* Patient and disease characteristics\n* Diagnostic profiles\n* Treatment profiles\n* Post-operative course'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients admitted to surgical departments with acute secondary peritonitis', 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Clinical diagnosis of acute (secondary) localized or diffuse peritonitis.\n\nExclusion Criteria:\n\n\\- Clinical diagnosis of acute pancreatitis'}, 'identificationModule': {'nctId': 'NCT03408600', 'acronym': 'PIPAS', 'briefTitle': 'Physiologic Indicators for Prognosis in Abdominal Sepsis Study', 'organization': {'class': 'OTHER', 'fullName': 'World Society of Emergency Surgery'}, 'officialTitle': 'Physiologic Indicators for Prognosis in Abdominal Sepsis (PIPAS) Study', 'orgStudyIdInfo': {'id': 'WSES/4'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Management', 'type': 'OTHER', 'description': '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.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '40139', 'city': 'Bologna', 'country': 'Italy', 'facility': 'WSES', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'World Society of Emergency Surgery', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Massimo Sartelli', 'investigatorAffiliation': 'World Society of Emergency Surgery'}}}}