- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01611532
An Observational Study of the Role of Intra-abdominal Pressure Monitoring in Patients With Acute Pancreatitis
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.
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Lanarkshire
-
Airdrie, Lanarkshire, United Kingdom, ML6OJS
- Monklands District General Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
30 day mortality
Time Frame: 30 days
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Length of hospital stay
Time Frame: days
|
days
|
Length of HDU/ICU admission
Time Frame: days
|
days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11/WS/0040
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Acute Pancreatitis
-
Centre Hospitalier Universitaire de NiceRecruiting
-
John Gasdal KarstensenCompleted
-
Tianjin Nankai HospitalCompletedAcute PancreatitisChina
-
Mayo ClinicNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)CompletedAcute Pancreatitis (AP) | Gallstone Pancreatitis | Alcoholic Pancreatitis | Trauma Acute Pancreatitis | Hypertriglyceridemia Acute Pancreatitis | Idiopathic (Unknown) Acute Pancreatitis | Medication Induced Acute Pancreatitis | Cancer Acute Pancreatitis | Miscellaneous (i.e. Acute on Chronic Pancreatitis)United States
-
Northern State Medical UniversityCompleted
-
Erzhen ChenRenJi HospitalUnknownPancreatitis,Acute NecrotizingChina
-
Orlando Health, Inc.Mayo Clinic; University of Alabama at Birmingham; University of Southern California and other collaboratorsActive, not recruitingPancreatitis,Acute NecrotizingUnited States
-
University of OuluCopenhagen University Hospital, HvidovreUnknownAcute Necrotizing PancreatitisFinland
-
Sichuan Academy of Medical SciencesPeking Union Medical College HospitalCompleted
-
Interscope, Inc.CompletedAcute Pancreatitis | Necrotizing Pancreatitis | Acute Pancreatic NecrosisUnited States, Netherlands, Germany