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

NCT01611532 | Completed

• 1 other identifier: 11/WS/0040
• Study Type: observational
• Target: 218
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Pancreatitis

Keywords

Acute pancreatitis; Intraabdominal pressure; Critical illness

Outcome Measures

Primary Outcomes (1)

• 30 day mortality

  30 days

Secondary Outcomes (2)

• Length of hospital stay

  days

• Length of HDU/ICU admission

  days

Study Arms (1)

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All adult patients with a diagnosis of acute pancreatitis

You may qualify if:

• All adult patients \>18y.o.
• Diagnosis of acute pancreatitis (defined as an amylase \>3 times the upper limit of normal and typical symptoms)

You may not qualify if:

• Inability to provide informed consent
• Declines participation
• Uretheral catheterisation not required on clinical grounds

Sponsors & Collaborators

• Emma Aitken: lead

Study Sites (1)

Monklands District General Hospital

Airdrie, Lanarkshire, ML6OJS, United Kingdom

Location

MeSH Terms

Conditions

Pancreatitis; Critical Illness

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Surgical Registrar

Study Record Dates

• First Submitted: June 1, 2012
• First Posted: June 5, 2012
• Study Start: November 1, 2010
• Primary Completion: November 1, 2011
• Study Completion: December 1, 2011
• Last Updated: June 5, 2012

Record last verified: 2012-06

Locations

GB (1)