Study to Assess the Prognostic Value of the Antithrombin III in the Acute Pancreatitis (AT-PROPANC) (AT-PROPANC)
Epidemiologic , Observational, Prospective Study to Assess the Prognostic Value of the Antithrombin III in the Development of Moderate or Severe Acute Pancreatitis (AT-PROPANC)
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Voraussichtlich)
Kontakte und Standorte
Studienkontakt
- Name: Francisco Javier García Borobia, Dr.
- Telefonnummer: 21461 +34 93 7231010
- E-Mail: fjgarcia@tauli.cat
Studienorte
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Barcelona
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Sabadell, Barcelona, Spanien, 08208
- Rekrutierung
- Corporació Sanitària Parc Taulí
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Kontakt:
- Francisco Javier -García Borobia, Dr.
- Telefonnummer: 21461 +34 93 7231010
- E-Mail: fjgarcia@tauli.cat
-
Hauptermittler:
- Francisco Javier García Borobia, Dr.
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Sant Joan Despí, Barcelona, Spanien, 08970
- Rekrutierung
- Hospital de Sant Joan Despí Moisès Broggi
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Kontakt:
- Robert Memba, Dr.
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Hauptermittler:
- Robert Memba, Dr.
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Beobachtungsmodelle: Kohorte
- Zeitperspektiven: Interessent
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
antithrombin III levels vs maximum seriousness grade of acute pancreatitis
Zeitfenster: At Admission and at 24h
|
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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
result of modified Marshall and Apache II scales
Zeitfenster: Admission and at 24h
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Admission and at 24h
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antithrombin III levels vs mortality
Zeitfenster: From date of admission until the end of study or date of death from any cause, whichever came first, assessed up to 1 month"
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Levels of antithrombin III at admission and at 24h will be related with mortality rates by logistic regression models
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From date of admission until the end of study or date of death from any cause, whichever came first, assessed up to 1 month"
|
|
antithrombin III levels vs organic failure
Zeitfenster: From date of admission until the end of study or date of organic failure, whichever came first, assessed up to 1 month"
|
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"
|
|
antithrombin III levels vs necrosis and infection rates
Zeitfenster: From date of admission until the end of study or date of necrosis or infection diagnosis, whichever came first, assessed up to 1 month"
|
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"
|
Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Francisco Javier García Borobia, Dr., Corporacion Parc Tauli
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Voraussichtlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- GAR-BOR/TAULI-2013
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