Heat Shock Proteins: a Pathogenic Driver and Potential Therapeutic Target in Acute Pancreatitis (DIAGNON)

August 15, 2018 updated by: Aiste Gulla, Vilnius University

To investigate the role of Heat Shock Proteins in the mechanism of acute severe pancreatitis. In addition to test the potential treatment target of acute pancreatitis.

All patients who present with clinical symptoms of acute pancreatitis are evaluated for the enrollment of the study.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

All patients with acute pancreatitis are evaluated according to modified Atlanta classification acute pancreatitis severity scores.

Blood serum, urine and DNA samples are collected from all patients presented on admission, after 24 hours, 48 hours, 72 hours.

CT is performed in al patients to evaluate necrosis of pancreas Day 5-7 since hospital admission. If necrosis is not present follow-up is stopped.

Study Type

Observational

Enrollment (Anticipated)

280

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Lithuania
      • Vilnius, Lithuania, 08410
        • Recruiting
        • Vilnius University Hospital "Santaros Klinikos
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kestutis Strupas, Prof. MD/phD
        • Sub-Investigator:
          • Aiste Gulla, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients admitted to the hospital within 48 hours since the typical symptoms of acute pancreatitis

Description

Inclusion Criteria:

  • no prior diagnosis of acute pancreatitis
  • admission to the hospital within 2 days since the clinical symptoms
  • confirmed diagnosis of acute pancreatitis

Exclusion Criteria:

  • chronic pancreatitis
  • pancreatic cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Acute pancreatitis
First time acute pancreatitis. No later than 2 days since the clinical symptoms started.
Diagnostic test: CT Scan Day 5-7
Computed Tomography on Day 5-7 according to a clinical protocol.
Healthy
No major systemic illness

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To measure the levels of heat shock proteins in serum and plasma in acute severe pancreatitis settings
Time Frame: 2 years
Different molecular weight Heat Shock proteins role while developing acute pancreatitis.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To measure pancreas cells activity while applying Heat Shock Protein inhibitors
Time Frame: 2 years
To establish a mechanism explaining the potential use of heat shock proteins inhibitors/ activators for treatment of acute pancreatitis
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vilnius University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 20, 2017

Primary Completion (ANTICIPATED)

December 1, 2021

Study Completion (ANTICIPATED)

December 30, 2021

Study Registration Dates

First Submitted

July 3, 2018

First Submitted That Met QC Criteria

August 15, 2018

First Posted (ACTUAL)

August 16, 2018

Study Record Updates

Last Update Posted (ACTUAL)

August 16, 2018

Last Update Submitted That Met QC Criteria

August 15, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 158200-17-941-455

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

We plan to share the data and recruitment status when the study reaches its requirement sample size

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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