Imunomodulation in Acute Pancreatitis

NCT ID: NCT04796311

Last Updated: 2024-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-26

Study Completion Date

2023-12-30

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Pancreatitis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Interventions

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blood samples

T cells, B cells and cytokines testing

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Filipa Malheiro

OTHER

Sponsor Role lead

Responsible Party

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Filipa Malheiro

Medical doctor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Filipa Malheiro, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital da Luz, Lisboa

Locations

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Hospital da Luz

Lisbon, , Portugal

Site Status

Countries

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Portugal

Other Identifiers

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LH.INV.F2019002

Identifier Type: -

Identifier Source: org_study_id

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