Imunomodulation in Acute Pancreatitis

NCT04796311 | Completed

• 1 other identifier: LH.INV.F2019002
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Acute pancreatitis is an acute inflammatory pathology of the pancreas with activation of both innate and adaptive immune system, including T and B lymphocytes and release of inflammatory cytokines. We aim to characterize the circulating profile of T and B cells, its regulatory populations and B cell maturation, as well as inflammatory cytokines, in a prospective way of 50 patients with acute pancreatitis admitted to Hospital da Luz Lisboa. Blood samples will be collected at hospital admission, 48h, one month and 6 months after hospitalization of patients, relating these values to the severity of acute pancreatitis. Patients with acute pancreatitis in the previous 6 months, diabetes mellitus, pregnant women, uncontrolled comorbidity and terminal neoplasms will be excluded. A control group of 30 ambulatory individuals observed at the Hospital da Luz Lisboa will be recruited. Laboratory evaluation will be performed at the Immunology Laboratory of NOVA Medical School.

Conditions

Acute Pancreatitis

Outcome Measures

Primary Outcomes (1)

• To characterize the immune profile of patients with acute pancreatitis at admission, 48h after admission and at 1 month and 6 months after discharge.

  1. Blood collection for evaluation of B and T cell subpopulations as well as IL-1, IL6, TNFalpha also in blood collections will be performed in patients with acute pancreatitis in the first 24h of diagnosis, at 48 hours of hospitalization, one month after hospitalization and six months after the first determination. 2. Application of the BISAP (Bedside Index of Severity in Acute Pancreatitis)score at admission 3. Blood collection for RCP (mg/dl) determination in peripheral blood of these patients at hospital admission, 48h after the first determination and at discharge from hospital

  4 years

Interventions

blood samples DIAGNOSTIC_TEST

T cells, B cells and cytokines testing

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

hospitalized patients with acute pancreatitis from 18 to 85 years old

You may qualify if:

• hospitalized patients with acute pancreatitis

You may not qualify if:

• acute pancreatitis in the last 6 months diabetes mellitus, pregnant women, uncontrolled comorbidity such as organ disease (cardiac, renal, hepatic) and terminal neoplasms

Sponsors & Collaborators

• Filipa Malheiro: lead

Study Sites (1)

Hospital da Luz

Lisbon, Portugal

Location

MeSH Terms

Conditions

Pancreatitis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Filipa Malheiro, MD

  Hospital da Luz, Lisboa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical doctor

Study Record Dates

• First Submitted: March 5, 2021
• First Posted: March 12, 2021
• Study Start: February 26, 2021
• Primary Completion: September 30, 2023
• Study Completion: December 30, 2023
• Last Updated: February 28, 2024

Record last verified: 2024-02

Locations

PT (1)