An Observational Study of the Role of Intra-abdominal Pressure Monitoring in Patients With Acute Pancreatitis

Sponsor
Emma Aitken (Other)
Overall Status
Completed
CT.gov ID
NCT01611532
Collaborator
(none)
218
1
13
16.8

Study Details

Study Description

Brief Summary

Acute pancreatitis is a multi-system disease with an unpredictable clinical course and significant morbidity and mortality Approximately 20% of patients develop multi-organ failure requiring management within a critical care environment However much of the pathophysiology of the disease, particularly understanding why some patients develop life-threatening disease whilst others have a relatively benign course, remains unclear.

It well recognised that intra-abdominal hypertension (IAH) is a cause for organ dysfunction in critically ill patients and is associated with higher morbidity and mortality rates (Sugrue et al., 1999). Abdominal compartment syndrome (defined as an increase in intra-abdominal pressure (IAP) >20mmHg) is associated with new organ failure (Malbrain et al., 2006). The mechanisms believed to contribute to IAH in acute pancreatitis include increased capillary permeability, hypoalbuminaemia and volume overload ("third space losses"), producing retroperitoneal and visceral oedema (Dambrauskas et al., 2009).

Several small studies have recently described the link between intra-abdominal hypertension and adverse outcome in acute pancreatitis ( Dambrauskas et al., 2009; de Waele et al., 2005), however none of the authors appreciate the potential predictive value of there conclusions or the potential as a target for therapeutic intervention to alter the disease course.

This study aims to study the natural history of intra-abdominal pressures in acute pancreatitis and determine whether they truly do have a predictive value or whether they are simply another marker of organ failure in a multi-system disease with notoriously poor outcome.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Acute pancreatitis is a multi-system disease with an unpredictable clinical course and significant morbidity and mortality (Wilmer, 2004). Approximately 20% of patients develop multi-organ failure requiring management within a critical care environment (Dambrauskas et al., 2009). However much of the pathophysiology of the disease, particularly understanding why some patients develop life-threatening disease whilst others have a relatively benign course, remains unclear.

    Many predictive scales have resulted from attempts to predict which patients are likely to develop severe disease (Imrie, Ranson, APACHE-II etc.) (Barreto & Rodriguez, 2007). However none of these scoring systems actually correlate clinical findings with the pathophysiology of the disease process, making comprehension of the rationale for the prognostic value which these scales have been shown to have difficult. This has lead latterly to interest in measurement of intra-abdominal pressures (IAP) as a potential novel method to predict outcome in acute pancreatitis (Buter et al., 2002) since intra-abdominal hypertension can be explained by the disease processes in acute pancreatitis.

    It well recognised that intra-abdominal hypertension (IAH) is a cause for organ dysfunction in critically ill patients and is associated with higher morbidity and mortality rates (Sugrue et al., 1999). Abdominal compartment syndrome (defined as an increase in IAP >20mmHg) is associated with new organ failure (Malbrain et al., 2006). The mechanisms believed to contribute to IAH in acute pancreatitis include increased capillary permeability, hypoalbuminaemia and volume overload ("third space losses"), producing retroperitoneal and visceral oedema (Dambrauskas et al., 2009).

    Several small studies have recently described the link between intra-abdominal hypertension and adverse outcome in acute pancreatitis ( Dambrauskas et al., 2009; de Waele et al., 2005), however none of the authors appreciate the potential predictive value of there conclusions or the potential as a target for therapeutic intervention to alter the disease course.

    This study aims to study the natural history of intra-abdominal pressures in acute pancreatitis and determine whether they truly do have a predictive value or whether they are simply another marker of organ failure in a multi-system disease with notoriously poor outcome.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    218 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    An Observational Study of the Role of Intra-abdominal Pressure Monitoring in Patients With Acute Pancreatitis
    Study Start Date :
    Nov 1, 2010
    Actual Primary Completion Date :
    Nov 1, 2011
    Actual Study Completion Date :
    Dec 1, 2011

    Arms and Interventions

    Arm Intervention/Treatment
    Acute pancreatitis

    All adult patients (>18y.o.) requiring admission for acute pancreatitis (amylase >3 times the upper limit of normal and typical symptoms of abdominal pain and vomiting)

    Outcome Measures

    Primary Outcome Measures

    1. 30 day mortality [30 days]

    Secondary Outcome Measures

    1. Length of hospital stay [days]

    2. Length of HDU/ICU admission [days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • All adult patients >18y.o.

    • Diagnosis of acute pancreatitis (defined as an amylase >3 times the upper limit of normal and typical symptoms)

    Exclusion Criteria:
    • Inability to provide informed consent

    • Declines participation

    • Uretheral catheterisation not required on clinical grounds

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Monklands District General Hospital Airdrie Lanarkshire United Kingdom ML6OJS

    Sponsors and Collaborators

    • Emma Aitken

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Emma Aitken, Surgical Registrar, NHS Greater Glasgow and Clyde
    ClinicalTrials.gov Identifier:
    NCT01611532
    Other Study ID Numbers:
    • 11/WS/0040
    First Posted:
    Jun 5, 2012
    Last Update Posted:
    Jun 5, 2012
    Last Verified:
    Jun 1, 2012
    Keywords provided by Emma Aitken, Surgical Registrar, NHS Greater Glasgow and Clyde
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 5, 2012