PeritonitisNCT01465711
The Value of PSP in Predicting Outcome in ICU Surgical Peritonitis Patients
An observational study of Peritonitis and Sepsis, run by University of Magdeburg at 1 site in Germany.
Trial summary
The purpose of this study is to determine the diagnostic accuracy of Pancreatic Stone Protein (PSP) in predicting patient outcomes with suspected peritonitis in the Intensive Care Unit after abdominal surgery and compare PPS with other blood parameters, including C-Reactive Protein (CRP), White Cell Count (WCC)… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Peritonitis, Sepsis, Multiple Organ Failure
- What is being tested?
- All abdominal surgical procedures, Intubation and Imaging
- Type of treatment
- Surgery or procedure
- How many people
- 137 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2007to Dec 2014
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary care clinics
Who may be able to join
- Abdominal surgery.
- Admission to the Intensive Care Unit (ICU).
- Blood sampling within 3 hours from admission to the ICU
- Patient over 18 years of age
Who cannot join
- Patients already treated for peritonitis.
- Patients referred from other hospitals with suspicion of peritonitis
- Patient age less than 18 years of age.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diagnostic Accuracy of Pancreatic Stone Protein in Predicting Severe Outcome in Patients With Peritonitis at the Intensive Care Unit
The purpose of this study is to determine the diagnostic accuracy of Pancreatic Stone Protein (PSP) in predicting patient outcomes with suspected peritonitis in the Intensive Care Unit after abdominal surgery and compare PPS with other blood parameters, including C-Reactive Protein (CRP), White Cell Count (WCC), Interleucin-6 (IL-6) and Procalcitonin (PCT).
Read the detailed description
Peritonitis is a severe complication after abdominal surgery. Patients admitted at the Intensive Care Unit (ICU) following surgery bear the risk of localized infection, sepsis or septic shock. Prevention or early detection of such events is important to intervene with an appropriate therapeutic action and avoid risking a potentially life-threatening situation. White blood cell counts (WCC) and C-Reactive Protein (CRP), Interleucin-6 (IL-6) and Procalcitonin (PCT) have all been promising parameters, however, they are useful only in selective cases and have a limited diagnostic accuracy.
- Conditions
- Peritonitis, Sepsis, Multiple Organ Failure, Death
- Being tested
- All abdominal surgical procedures, Intubation, Imaging
- Keywords
- Peritonitis, Sepsis, General Surgery, Intensive Care Units, Sensitivity and Specificity
- Medical subject headings
- Peritonitis, Sepsis, Multiple Organ Failure, Death, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
All abdominal surgical proceduresProcedure or surgery
Also called surgical procedures
Laparotomy, Laparoscopy
IntubationProcedure or surgery
Also called Endotracheal Intubation, tracheostomy
Ventilatory support
ImagingRadiation
Also called Any type of diagnostic or interventional imaging technique
Abdominal ultrasound Computer Tomography Magnetic Resonance Imaging
| Study group | Role | What they receive |
|---|---|---|
| Control | Admission to the Intensive Care Unit (ICU) after abdominal surgery without suspicion / evidence of peritonitis. Receives: Procedure: All abdominal surgical procedures; Procedure: Intubation; Radiation: Imaging | |
| Peritonitis | Admission to the Intensive Care Unit (ICU) after abdominal surgery with suspicion / evidence of peritonitis Receives: Procedure: All abdominal surgical procedures; Procedure: Intubation; Radiation: Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Localization of Peritonitis
Localised vs. diffused. A clinical finding intra-operatively and/or radiologically (i.e. CT or MRI)
Measured: up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2011 (estimated)
- Study startJul 2007
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Magdeburg
- Sponsor type
- University, hospital or other
- Collaborators
- University of Zurich
- Responsible party
- Principal investigator, Antje Wiede, University of Magdeburg
- Investigators
- Walter Halangk, PhD, Principal investigator, University of Magdeburg, Department of General, Visceral and Vascular Surgery, Leipziger Str. 44, DE-39120, Magdeburg, GermanyHans-Ulrich Schulz, MD, Principal investigator, University of Magdeburg, Department of General, Visceral and Vascular Surgery, Leipziger Str. 44, DE-39120, Magdeburg, GermanyRolf Graf, PhD, Principal investigator, University Hospital Zurich, Department of Surgery, Raemistrasse 100, CH-8091, Zurich, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01465711
- Sponsor's protocol ID
- 33/01
- Status last verified
- Nov 2011
- First submitted
- 28 Oct 2011
- Last updated
- 3 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gukasjan R, Raptis DA, Schulz HU, Halangk W, Graf R. Pancreatic stone protein predicts outcome in patients with peritonitis in the ICU. Crit Care Med. 2013 Apr;41(4):1027-36. doi: 10.1097/CCM.0b013e3182771193.
PubMed 23399938
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy of Pancreatic Stone Protein in Predicting Severe Outcome in Patients With Peritonitis at the Intensive Care Unit
- ClinicalTrials.gov ID
- NCT01465711
- Acronym / sponsor ID
- 33/01
- Conditions
- Peritonitis, Sepsis, Multiple Organ Failure, Death
- Keywords
- Peritonitis, Sepsis, General Surgery, Intensive Care Units, Sensitivity and Specificity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- University of MagdeburgUniversity, hospital or other
- Collaborators
- University of Zurich
- Study start
- Jul 2007
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 7 Nov 2011 (estimated)
- 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.
The purpose of this study is to determine the diagnostic accuracy of Pancreatic Stone Protein (PSP) in predicting patient outcomes with suspected peritonitis in the Intensive Care Unit after abdominal surgery and compare PPS with other blood parameters, including C-Reactive Protein (CRP), White Cell Count (WCC), Interleucin-6 (IL-6) and Procalcitonin (PCT).
Detailed description
Peritonitis is a severe complication after abdominal surgery. Patients admitted at the Intensive Care Unit (ICU) following surgery bear the risk of localized infection, sepsis or septic shock. Prevention or early detection of such events is important to intervene with an appropriate therapeutic action and avoid risking a potentially life-threatening situation. White blood cell counts (WCC) and C-Reactive Protein (CRP), Interleucin-6 (IL-6) and Procalcitonin (PCT) have all been promising parameters, however, they are useful only in selective cases and have a limited diagnostic accuracy.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | Procedure: All abdominal surgical procedures, Procedure: Intubation, Radiation: ImagingAdmission to the Intensive Care Unit (ICU) after abdominal surgery without suspicion / evidence of peritonitis. |
| Peritonitis | – | Procedure: All abdominal surgical procedures, Procedure: Intubation, Radiation: ImagingAdmission to the Intensive Care Unit (ICU) after abdominal surgery with suspicion / evidence of peritonitis |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinics
Key inclusion criteria (4 listed)
- Abdominal surgery.
- Admission to the Intensive Care Unit (ICU).
- Blood sampling within 3 hours from admission to the ICU
- Patient over 18 years of age
Key exclusion criteria (3 listed)
- Patients already treated for peritonitis.
- Patients referred from other hospitals with suspicion of peritonitis
- Patient age less than 18 years of age.
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 |
|---|---|---|
| All abdominal surgical proceduresAlso: surgical proceduresLaparotomy, Laparoscopy | Procedure or surgery | Control, Peritonitis |
| IntubationAlso: Endotracheal Intubation, tracheostomyVentilatory support | Procedure or surgery | Control, Peritonitis |
| ImagingAlso: Any type of diagnostic or interventional imaging techniqueAbdominal ultrasound Computer Tomography Magnetic Resonance Imaging | Radiation | Control, Peritonitis |
Primary outcome
Localization of Peritonitis
Time frame: up to 2 months
Localised vs. diffused. A clinical finding intra-operatively and/or radiologically (i.e. CT or MRI)
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 3 Dec 2014.
- Derived from this study: PubMed 23399938Gukasjan R, Raptis DA, Schulz HU, Halangk W, Graf R. Pancreatic stone protein predicts outcome in patients with peritonitis in the ICU. Crit Care Med. 2013 Apr;41(4):1027-36. doi: 10.1097/CCM.0b013e3182771193.
Related trials for Peritonitis
Recruiting
Optimal Treatment Strategy for Spontaneous Bacterial Peritonitis
Spontaneous Bacterial Peritonitis, Paracentesis
RecruitingObservational study
AIDE: Decision Support for Anastomosis or Colostomy in Emergency Surgery for Complicated Acute Diverticulitis
Complicated Diverticulitis, Acute Diverticulitis
RecruitingPhase 1/2
Nitazoxanide in Spontaneous Bacterial Peritonitis
SBP - Spontaneous Bacterial Peritonitis
RecruitingPhase 1/2
N-Acetylcysteine in the Management of Spontaneous Bacterial Peritonitis
SBP - Spontaneous Bacterial Peritonitis
Recruiting
Vacuum Assisted Closure Versus On-demand Relaparotomy in Patients With Fecal or Diffuse Peritonitis
Fecal Peritonitis, Secondary 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.
Walter Halangk, PhD principal investigator
University of Magdeburg, Department of General, Visceral and Vascular Surgery, Leipziger Str. 44, DE-39120, Magdeburg, Germany
Hans-Ulrich Schulz, MD principal investigator
University of Magdeburg, Department of General, Visceral and Vascular Surgery, Leipziger Str. 44, DE-39120, Magdeburg, Germany
Rolf Graf, PhD principal investigator
University Hospital Zurich, Department of Surgery, Raemistrasse 100, CH-8091, Zurich, Switzerland
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 Peritonitis and Sepsis, run by University of Magdeburg at 1 site in Germany.
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 4 inclusion and 3 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 3 Dec 2014. 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 Germany. 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?
Localization of Peritonitis (time frame: up to 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01465711, which also lists 1 linked publication.
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 3 Dec 2014.