Acute PancreatitisNCT03028181
The Evaluation of Pro/Antioxidative Profile and Diagnostic Parameters in the Patients With Pancreatic Disease
An observational study of Acute Pancreatitis, run by Wroclaw Medical University.
Trial summary
The study aims to assess and analyze some selected antioxidants and laboratory parameters during hospitalization of the patients with acute pancreatitis. It will allow to better understanding of the mechanisms of disease and the development of better diagnostic, treatment and monitoring. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Acute Pancreatitis
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Dec 2016
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 1. The healthy volunteers classified as a control group based on the research conducted by clinicians of primary medical care, divided on smokers and non-smokers. 2. The patients classified into the group of patients with acute pancreatitis, divided on smokers and non-smokers.
Who may be able to join
- The patients were classified into the group of patients with acute pancreatitis (AP) due to clinical symptoms (acute onset of a persistent, severe, epigastric pain with tenderness on palpation on physical examination), personal interview and clinical method used in the diagnosis of pancreatitis - laboratory tests (elevation in serum lipase or amylase to three times or greater than the upper limit of normal) and characteristic findings of acute pancreatitis on imaging (contrast-enhanced computed tomography (CT), magnetic resonance imaging (MRI) or transabdominal ultrasonography). In patients with characteristic abdominal pain and elevation in serum lipase or amylase to three times or greater than the upper limit of normal, no imaging was required to establish the diagnosis of acute pancreatitis. In patients with abdominal pain that was not characteristic for acute pancreatitis or serum amylase or lipase levels that were less than three times the upper limit of normal, or in whom the diagnosis was uncertain, the investigators performed abdominal imaging with a contrast-enhanced abdominal CT scan to establish the diagnosis of acute pancreatitis and to exclude other causes of acute abdominal pain. In patients with severe contrast allergy or renal failure, the investigators performed an abdominal MRI without gadolinium.
- The volunteers classified as healthy based on the research conducted by clinicians of primary medical care (control group)
Who cannot join
- other accompanied diseases than acute pancreatitis (the patients groups)
- Individuals of the control group with diagnosed disease as well as alcohol and drugs abusers
About this study
Official title: The Evaluation of Pro/Antioxidative Profile and Diagnostic Parameters in the Patients With Acute Pancreatitis
The study aims to assess and analyze some selected antioxidants and laboratory parameters during hospitalization of the patients with acute pancreatitis. It will allow to better understanding of the mechanisms of disease and the development of better diagnostic, treatment and monitoring.
It is an observational diagnostic study and does not involve any additional administration of medicinal substances, modification of treatment or dropping the use of routine methods of treatment of a disease. The study procedure includes detailed personal medical history as separate document like as a routine medical interview, and three times taking a small amount of venous blood (together about 15 ml), in the first, third, and seventh day of hospitalization (in the case of longer hospital treatment).
- Conditions
- Acute Pancreatitis
- Keywords
- smoke, acute pancreatitis, pro/antioxidant status, pro-inflammatory factors, lipid profile, exocrine functions of pancreas
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Control group non-exposed to tobacco smoking | |
| 2 | Control group exposed to tobacco smoking | |
| 3 | Patients with acute pancreatitis non-exposed to tobacco smoking | |
| 4 | Patients with acute pancreatitis exposed to tobacco smoking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pro-inflammatory effect of tobacco smoke exposure measured by hsCRP concentration in the blood of patients with acute pancreatitis
Measured: 3 weeks
Pro-inflammatory effect of tobacco smoke exposure measured by Interleukin-6 concentration in the blood of patients with acute pancreatitis
Measured: 2 weeks
Secondary outcomes (4)
The estimation of antioxidant status measured by the activities of antioxidant enzymes in the blood
Measured: 12 months
The estimation of antioxidant status measured by small molecular antioxidants concentration in the blood
Measured: 3 months
The estimation of prooxidant status measured by the concentration of lipids peroxidation products in the blood
Measured: 2 months
The estimation of prooxidant status measured by the concentration of advanced oxidation protein products in the blood
Measured: 1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2017 (estimated)
- Study startJan 2014
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PancreatitisStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wroclaw Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Milena Ściskalska, Wroclaw Medical University
- Investigators
- Halina Milnerowicz, Prof., Study chair, Wroclaw Medical University, Wroclaw, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03028181
- Sponsor's protocol ID
- 896-000-57-79
- Status last verified
- Jan 2017
- First submitted
- 13 Jan 2017
- Last updated
- 23 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of Pro/Antioxidative Profile and Diagnostic Parameters in the Patients With Acute Pancreatitis
- ClinicalTrials.gov ID
- NCT03028181
- Acronym / sponsor ID
- 896-000-57-79
- Conditions
- Acute Pancreatitis
- Keywords
- smoke, acute pancreatitis, pro/antioxidant status, pro-inflammatory factors, lipid profile, exocrine functions of pancreas
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Wroclaw Medical UniversityUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 23 Jan 2017 (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 study aims to assess and analyze some selected antioxidants and laboratory parameters during hospitalization of the patients with acute pancreatitis. It will allow to better understanding of the mechanisms of disease and the development of better diagnostic, treatment and monitoring.
It is an observational diagnostic study and does not involve any additional administration of medicinal substances, modification of treatment or dropping the use of routine methods of treatment of a disease. The study procedure includes detailed personal medical history as separate document like as a routine medical interview, and three times taking a small amount of venous blood (together about 15 ml), in the first, third, and seventh day of hospitalization (in the case of longer hospital treatment).
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Control group non-exposed to tobacco smoking |
| 2 | – | –Control group exposed to tobacco smoking |
| 3 | – | –Patients with acute pancreatitis non-exposed to tobacco smoking |
| 4 | – | –Patients with acute pancreatitis exposed to tobacco smoking |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 1. The healthy volunteers classified as a control group based on the research conducted by clinicians of primary medical care, divided on smokers and non-smokers. 2. The patients classified into the group of patients with acute pancreatitis, divided on smokers and non-smokers.
Key inclusion criteria (2 listed)
- The patients were classified into the group of patients with acute pancreatitis (AP) due to clinical symptoms (acute onset of a persistent, severe, epigastric pain with tenderness on palpation on physical examination), personal interview and clinical method used in the diagnosis of pancreatitis - laboratory tests (elevation in serum lipase or amylase to three times or greater than the upper limit of normal) and characteristic findings of acute pancreatitis on imaging (contrast-enhanced computed tomography (CT), magnetic resonance imaging (MRI) or transabdominal ultrasonography). In patients with characteristic abdominal pain and elevation in serum lipase or amylase to three times or greater than the upper limit of normal, no imaging was required to establish the diagnosis of acute pancreatitis. In patients with abdominal pain that was not characteristic for acute pancreatitis or serum amylase or lipase levels that were less than three times the upper limit of normal, or in whom the diagnosis was uncertain, the investigators performed abdominal imaging with a contrast-enhanced abdominal CT scan to establish the diagnosis of acute pancreatitis and to exclude other causes of acute abdominal pain. In patients with severe contrast allergy or renal failure, the investigators performed an abdominal MRI without gadolinium.
- The volunteers classified as healthy based on the research conducted by clinicians of primary medical care (control group)
Key exclusion criteria (2 listed)
- other accompanied diseases than acute pancreatitis (the patients groups)
- Individuals of the control group with diagnosed disease as well as alcohol and drugs abusers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pro-inflammatory effect of tobacco smoke exposure measured by hsCRP concentration in the blood of patients with acute pancreatitis
Time frame: 3 weeks
Pro-inflammatory effect of tobacco smoke exposure measured by Interleukin-6 concentration in the blood of patients with acute pancreatitis
Time frame: 2 weeks
4 secondary outcomes
The estimation of antioxidant status measured by the activities of antioxidant enzymes in the blood
Time frame: 12 months
The estimation of antioxidant status measured by small molecular antioxidants concentration in the blood
Time frame: 3 months
The estimation of prooxidant status measured by the concentration of lipids peroxidation products in the blood
Time frame: 2 months
The estimation of prooxidant status measured by the concentration of advanced oxidation protein products in the blood
Time frame: 1 months
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 23 Jan 2017.
- Individual participant dataSharing planned: No
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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.
Halina Milnerowicz, Prof. study chair
Wroclaw Medical University, Wroclaw, Poland
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Pancreatitis, run by Wroclaw Medical University.
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 2 inclusion and 2 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 23 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Pro-inflammatory effect of tobacco smoke exposure measured by hsCRP concentration in the blood of patients with acute pancreatitis (time frame: 3 weeks). The study lists 2 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 23 Jan 2017; AzTrials last refreshed its copy on 6 Nov 2026.