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Completed

NCT Number: NCT04796311

Imunomodulation in Acute Pancreatitis

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.

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Key information

Conditions

Acute Pancreatitis Digestive System Diseases Pancreatic Diseases Pancreatitis

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital da Luz

Lisbon, Portugal

Who can participate

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

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

Treatment and study plan

Blood samples

Diagnostic Test

T cells, B cells and cytokines testing

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.

    Time frame: 4 years

    • 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

Sponsors and collaborators

Lead sponsor

Filipa Malheiro

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Mar 12, 2021
Registry last updated
Feb 28, 2024

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.

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