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Acute PancreatitisNCT01611532

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

An observational study of Acute Pancreatitis, run by Emma Aitken at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Pancreatitis
How many people
218 participants
Where
1 siteUnited Kingdom
Study dates
Nov 2010to Dec 2011
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: All adult patients with a diagnosis of acute pancreatitis

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • Monklands District General Hospital

    Airdrie, Lanarkshire, ML6OJS

Other trials in United Kingdom

About this study

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).

Read more

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.

Read the 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.

Keywords
Acute pancreatitis, Intraabdominal pressure, Critical illness
Medical subject headings
Pancreatitis, Critical Illness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01611532
Study groupRoleWhat they receive
Acute pancreatitisAll 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. 30 day mortality

    Measured: 30 days

Secondary outcomes (2)
  1. Length of hospital stay

    Measured: days

  2. Length of HDU/ICU admission

    Measured: days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jun 2012 (estimated)
  2. Study startNov 2010
  3. Primary completionNov 2011
  4. Study completionDec 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
218 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01611532
Sponsor's protocol ID
11/WS/0040
Status last verified
Jun 2012
First submitted
1 Jun 2012
Last updated
5 Jun 2012
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Pancreatitis, run by Emma Aitken at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

30 day mortality (time frame: 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2012.

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