Acute PeritonitisPIPASNCT03408600
Physiologic Indicators for Prognosis in Abdominal Sepsis Study
An observational study of Acute Peritonitis and Abdominal Sepsis, run by World Society of Emergency Surgery at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Peritonitis, Abdominal Sepsis
- What is being tested?
- Management
- How many people
- 4,000 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2018to 31 May 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: All patients admitted to surgical departments with acute secondary peritonitis
Who may be able to join
- Clinical diagnosis of acute (secondary) localized or diffuse peritonitis.
Who cannot join
- Clinical diagnosis of acute pancreatitis
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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
- Conditions
- Acute Peritonitis, Abdominal Sepsis
- Being tested
- Management
- Keywords
- Abdominal sepsis, Secondary peritonitis, Complicated intra-abdominal infections
- Medical subject headings
- Intraabdominal Infections, Peritonitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory rate predicting mortality in patients with acute secondary peritonitis at admission
Respiratory rate (breaths/min);
Measured: 24 weeks
Blood oxygen saturation level predicting mortality in patients with acute secondary peritonitis at admission
Blood oxygen saturation level (SpO2) (%) in air
Measured: 24 weeks
Core temperature predicting mortality in patients with acute secondary peritonitis at admission
Core temperature (°C);
Measured: 24 weeks
Systolic blood pressure predicting mortality in patients with acute secondary peritonitis at admission
Systolic blood pressure (mmHg);
Measured: 24 weeks
Hearth rate predicting mortality in patients with acute secondary peritonitis at admission
Hearth rate (bpm);
Measured: 24 weeks
Responsiveness predicting mortality in patients with acute secondary peritonitis at admission
Alert/verbal/painful/unresponsive (AVPU) responsiveness scale;
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2018
- Study start1 Feb 2018
- Primary completion1 May 2018
- Study completion31 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PeritonitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- World Society of Emergency Surgery
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Massimo Sartelli, World Society of Emergency Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03408600
- Sponsor's protocol ID
- WSES/4
- Acronym
- PIPAS
- Status last verified
- Jan 2018
- First submitted
- 5 Jan 2018
- Last updated
- 18 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiologic Indicators for Prognosis in Abdominal Sepsis (PIPAS) Study
- ClinicalTrials.gov ID
- NCT03408600
- Acronym / sponsor ID
- PIPAS / WSES/4
- Conditions
- Acute Peritonitis, Abdominal Sepsis
- Keywords
- Abdominal sepsis, Secondary peritonitis, Complicated intra-abdominal infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,000 participants (actual)
- Lead sponsor
- World Society of Emergency SurgeryUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 31 May 2018 (actual)
- First posted
- 24 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- All patients admitted to surgical departments with acute secondary peritonitis
Key inclusion criteria (1 listed)
- Clinical diagnosis of acute (secondary) localized or diffuse peritonitis.
Key exclusion criteria (1 listed)
- Clinical diagnosis of acute pancreatitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ManagementTo 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. | Other | – |
Primary outcome
Respiratory rate predicting mortality in patients with acute secondary peritonitis at admission
Time frame: 24 weeks
Respiratory rate (breaths/min);
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
Core temperature predicting mortality in patients with acute secondary peritonitis at admission
Time frame: 24 weeks
Core temperature (°C);
Systolic blood pressure predicting mortality in patients with acute secondary peritonitis at admission
Time frame: 24 weeks
Systolic blood pressure (mmHg);
Hearth rate predicting mortality in patients with acute secondary peritonitis at admission
Time frame: 24 weeks
Hearth rate (bpm);
Responsiveness predicting mortality in patients with acute secondary peritonitis at admission
Time frame: 24 weeks
Alert/verbal/painful/unresponsive (AVPU) responsiveness scale;
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2018.
- Individual participant dataSharing planned: Yes
Related trials for Acute Peritonitis
Not yet recruitingObservational study
AIDE: Decision Support for Anastomosis or Colostomy in Emergency Surgery for Complicated Acute Diverticulitis
Complicated Diverticulitis, Acute Diverticulitis
Recruiting
Benefit of Hypnosis on Smartphone for Acute Post-operative Pain (HYPNO-APP)
Appendicitis With Peritonitis
Not yet recruitingObservational study
Laparoscopic Versus Open Appendectomy Plus Peritoneal Lavage for Acute Complicated Appendicitis Patients With Diffuse Peritonitis
Acute Complicated Appendicitis With Diffuse Peritonitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Peritonitis and Abdominal Sepsis, run by World Society of Emergency Surgery at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory rate predicting mortality in patients with acute secondary peritonitis at admission (time frame: 24 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2018.