Skip to main content
OpenTrials
Completed

NCT Number: NCT03028181

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Pro-inflammatory effect of tobacco smoke exposure measured by hsCRP concentration in the blood of patients with acute pancreatitis

    Time frame: 3 weeks

  2. Pro-inflammatory effect of tobacco smoke exposure measured by Interleukin-6 concentration in the blood of patients with acute pancreatitis

    Time frame: 2 weeks

Secondary outcomes

  1. The estimation of antioxidant status measured by the activities of antioxidant enzymes in the blood

    Time frame: 12 months

  2. The estimation of antioxidant status measured by small molecular antioxidants concentration in the blood

    Time frame: 3 months

  3. The estimation of prooxidant status measured by the concentration of lipids peroxidation products in the blood

    Time frame: 2 months

  4. The estimation of prooxidant status measured by the concentration of advanced oxidation protein products in the blood

    Time frame: 1 months

Other outcomes

  1. The estimation of the concentration of vascular endothelium damage marker (endothelin) in the blood

    Time frame: 3 months

  2. The estimation of the concentration of total cholesterol in the blood

    Time frame: 3 weeks

  3. The estimation of the concentration of triglycerides in the blood

    Time frame: 3 weeks

  4. The estimation of the concentration of low-density lipoprotein (LDL) in the blood

    Time frame: 3 months

  5. The estimation of the concentration of high-density lipoprotein (HDL) in the blood

    Time frame: 3 weeks

  6. The estimation of endocrine functions of pancreas measured by the concentration of insulin in the blood

    Time frame: 2 months

  7. The estimation of endocrine functions of pancreas measured by the concentration of glucagon in the blood

    Time frame: 1 month

  8. The estimation of endocrine functions of pancreas measured by the concentration of pancreatic polypeptide in the blood

    Time frame: 1 month

  9. The estimation of endocrine functions of pancreas measured by the concentration of somatostatin in the blood

    Time frame: 1 month

  10. The estimation of endocrine functions of pancreas measured by the concentration of ghrelin in the blood

    Time frame: 2 weeks

  11. The estimation of exocrine functions of pancreas measured by the activity of amylase and lipase in the blood

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Wroclaw Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jan 23, 2017
Registry last updated
Jan 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.