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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Emma Aitken, NHS Greater Glasgow and Clyde
ClinicalTrials.gov Identifier:
NCT01611532
First received: June 1, 2012
Last updated: NA
Last verified: June 2012
History: No changes posted
  Purpose

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
Acute Pancreatitis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Observational Study of the Role of Intra-abdominal Pressure Monitoring in Patients With Acute Pancreatitis

Resource links provided by NLM:


Further study details as provided by NHS Greater Glasgow and Clyde:

Primary Outcome Measures:
  • 30 day mortality [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Length of hospital stay [ Time Frame: days ] [ Designated as safety issue: No ]
  • Length of HDU/ICU admission [ Time Frame: days ] [ Designated as safety issue: No ]

Enrollment: 218
Study Start Date: November 2010
Study Completion Date: December 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

All adult patients with a diagnosis of acute pancreatitis

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01611532

Locations
United Kingdom
Monklands District General Hospital
Airdrie, Lanarkshire, United Kingdom, ML6OJS
Sponsors and Collaborators
Emma Aitken
  More Information

No publications provided

Responsible Party: Emma Aitken, Surgical Registrar, NHS Greater Glasgow and Clyde
ClinicalTrials.gov Identifier: NCT01611532     History of Changes
Other Study ID Numbers: 11/WS/0040
Study First Received: June 1, 2012
Last Updated: June 1, 2012
Health Authority: United Kingdom: Reserach Ethics Committee

Keywords provided by NHS Greater Glasgow and Clyde:
Acute pancreatitis
Intraabdominal pressure
Critical illness

Additional relevant MeSH terms:
Pancreatitis
Digestive System Diseases
Pancreatic Diseases

ClinicalTrials.gov processed this record on October 22, 2014