The Evaluation of Pro/Antioxidative Profile and Diagnostic Parameters in the Patients With Pancreatic Disease

Acute Pancreatitis Clinical Trial

Official title:

The Evaluation of Pro/Antioxidative Profile and Diagnostic Parameters in the Patients With Acute Pancreatitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03028181
• Other study ID #: 896-000-57-79
• Status: Completed
• Phase: N/A
• First received: January 13, 2017
• Last updated: January 20, 2017
• Start date: January 2014
• Est. completion date: December 2016

Study information

• Verified date: January 2017
• Source: Wroclaw Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• other accompanied diseases than acute pancreatitis (the patients groups)

• Individuals of the control group with diagnosed disease as well as alcohol and drugs abusers

Related Conditions & MeSH terms

• Acute Pancreatitis
• Pancreatitis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wroclaw Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The estimation of the concentration of vascular endothelium damage marker (endothelin) in the blood		3 months
Other	The estimation of the concentration of total cholesterol in the blood		3 weeks
Other	The estimation of the concentration of triglycerides in the blood		3 weeks
Other	The estimation of the concentration of low-density lipoprotein (LDL) in the blood		3 months
Other	The estimation of the concentration of high-density lipoprotein (HDL) in the blood		3 weeks
Other	The estimation of endocrine functions of pancreas measured by the concentration of insulin in the blood		2 months
Other	The estimation of endocrine functions of pancreas measured by the concentration of glucagon in the blood		1 month
Other	The estimation of endocrine functions of pancreas measured by the concentration of pancreatic polypeptide in the blood		1 month
Other	The estimation of endocrine functions of pancreas measured by the concentration of somatostatin in the blood		1 month
Other	The estimation of endocrine functions of pancreas measured by the concentration of ghrelin in the blood		2 weeks
Other	The estimation of exocrine functions of pancreas measured by the activity of amylase and lipase in the blood		3 months
Primary	Pro-inflammatory effect of tobacco smoke exposure measured by hsCRP concentration in the blood of patients with acute pancreatitis		3 weeks
Primary	Pro-inflammatory effect of tobacco smoke exposure measured by Interleukin-6 concentration in the blood of patients with acute pancreatitis		2 weeks
Secondary	The estimation of antioxidant status measured by the activities of antioxidant enzymes in the blood		12 months
Secondary	The estimation of antioxidant status measured by small molecular antioxidants concentration in the blood		3 months
Secondary	The estimation of prooxidant status measured by the concentration of lipids peroxidation products in the blood		2 months
Secondary	The estimation of prooxidant status measured by the concentration of advanced oxidation protein products in the blood		1 months