Have you or your loved ones been diagnosed with acute pancreatitis?

You may be eligible to participate in a acute pancreatitis clinical trial.

Have you or your loved ones been diagnosed with acute pancreatitis? You may be eligible to participate in a acute pancreatitis clinical trial.

What is a clinical trial? Is participating in a clinical trial right for you? Learn more

Acute Pancreatitis Clinical Trial

NCT02373293 | Observational

Have you or your loved ones been diagnosed with acute pancreatitis?

You may be eligible to participate in a acute pancreatitis clinical trial.

Have you or your loved ones been diagnosed with acute pancreatitis? You may be eligible to participate in a acute pancreatitis clinical trial.

Recruiting

Male & Female

18 Years +

This study is looking to recruit 400 Participants

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Details for the study

Population

Adult patients with mild acute pancreatitis

Brief Title

Study to Assess the Prognostic Value of the Antithrombin III in the Acute Pancreatitis (AT-PROPANC)

Official Title

Epidemiologic , Observational, Prospective Study to Assess the Prognostic Value of the Antithrombin III in the Development of Moderate or Severe Acute Pancreatitis (AT-PROPANC)

Brief Summary

This is an epidemiological, observational, prospective, multicentric study in 400 adult<br /> patients admitted to hospital for mild acute pancreatitis to to assess the prognostic value<br /> of the antithrombin III in the development of moderate or severe acute pancreatitis.

Detailed Description

This is an epidemiological, observational, prospective, multicentric study in 400 adult
patients admitted to hospital for mild acute pancreatitis to to assess the prognostic value
of the antithrombin III in the development of moderate or severe acute pancreatitis.

In the context of clinical practice of general surgery and apparatus digestive services,
patients entering with mild acute pancreatitis will be asked to participate in the study and
if so, they will sign the informed consent.

On admission, demographic and anthropometric data of the patient will be recorded, as well as
medical history, patient's admission data and vital signs. Patient's blood will be drawn for
analysys and the risk of organ failure will be measured by modified Marshall and Apache II
scales. The assessments and procedures performed are the standard practice at the center.

At 24 hours (± 3 hours) and at 7 days (or nine days to avoid weekends) after admisison, vital
signs will be recorded, laboratory tests will be performed and the risk of organ failure will
be measured by modified Marshall and Apache II scales.

At discharge of the patient (regardless of when it occurs), the outcome of the acute
pancreatitis will be recorded.

. Those patients discharged within the first month after admission will be visited or called
(according to standard practice at the center) one month after arrival, to record follow-up
data, including health condition, readmissions and abdominal pain evaluation by visual analog
scale.

Outcome Measures

Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.

Primary

antithrombin III levels vs maximum seriousness grade of acute pancreatitis

Levels of antithrombin III at admission and at 24h will be related with maximum seriousness grade of acute pancreatitis reached during patient's admission at site by logistic regression models

At Admission and at 24h

Secondary

antithrombin III levels vs necrosis and infection rates

Levels of antithrombin III at admission and at 24h will be related with necrosis and infection rates by logistic regression models

From date of admission until the end of study or date of necrosis or infection diagnosis, whichever came first, assessed up to 1 month"

Secondary

antithrombin III levels vs organic failure

Levels of antithrombin III at admission and at 24h will be related with organic failure rates by logistic regression models

From date of admission until the end of study or date of organic failure, whichever came first, assessed up to 1 month"

Secondary

antithrombin III levels vs mortality

Levels of antithrombin III at admission and at 24h will be related with mortality rates by logistic regression models

From date of admission until the end of study or date of death from any cause, whichever came first, assessed up to 1 month"

Study Criteria

Inclusion Criteria:

  -  Patients diagnosed with mild acute pancreatitis according to seriousness criteria
     established by Banks et al, 2013.

  -  Patients of either sex aged ≥ 18 years .

  -  Patients who have given their written informed consent

Exclusion Criteria:

  -  Patients with exacerbated chronic pancreatitis.

  -  Patients with coagulation disorders (congenital and acquired antithrombin deficiency)
     .

  -  Patients with liver cirrhosis.

  -  Pregnant patients