Imunomodulation in Acute Pancreatitis

Acute Pancreatitis Clinical Trial

Official title:

Imunomodulation in Acute Pancreatitis- How Can Cytokines, B and T Cells Predict the Outcome of the Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04796311
• Other study ID #: LH.INV.F2019002
• Status: Completed
• Start date: February 26, 2021
• Est. completion date: December 30, 2023

Study information

• Verified date: February 2024
• Source: Hospital da Luz, Portugal
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 30, 2023
• Est. primary completion date: September 30, 2023
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• hospitalized patients with acute pancreatitis

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Acute Pancreatitis
• Pancreatitis

Intervention

Diagnostic Test:
• blood samples
T cells, B cells and cytokines testing

Locations

Country	Name	City	State
Portugal	Hospital da Luz	Lisbon

Sponsors (1)

Lead Sponsor	Collaborator
Filipa Malheiro

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To characterize the immune profile of patients with acute pancreatitis at admission, 48h after admission and at 1 month and 6 months after discharge.	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.; Application of the BISAP (Bedside Index of Severity in Acute Pancreatitis)score at admission; 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