Clinical Trial: Abdominal Compartment Syndrome : Diagnostic and Prognostic Value of CT Findings - a Prospective Study

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Observational

Official Title: Abdominal Compartment Syndrome : Diagnostic and Prognostic Value of CT Findings - a Prospective Study

Brief Summary:

Abdominal Compartment Syndrome (ACS) is a well known condition occuring in critically ill patients in intensive care units.

This syndrome features a sustained intra abdominal hypertension (IAH) above 20 mmHg and a multiple organ failure due to the raise of the intra abdominal pressure.

Several reviews described CT findings linked to these conditions, but most of them suffer an insufficient statistical method.

Furthermore, the main CT feature described as specific in ACS, Round Belly Sign (RBS), has been highly debated since.

This study is aimed to evaluate, in a prospective way, the diagnostic and prognostic value of CT findings in abdominal hypertension and abdominal compartment syndrome patients hosted in intensive care units, based on previous reviews and adding three new CT features described for the first time.

Detailed Summary:

Abdominal compartment syndrome (ACS) is a well known condition, occurring in patients hosted in intensive care units and suffering from acute abdominal disease (such as severe acute pancreatitis, trauma, hemoperitoneum, surgery, infectious disease), large volume fluid resuscitation (over 2,5L), and systemic disease such as severe sepsis or major burns.

This syndrome features a sustained intra abdominal hypertension (IAH) above 20 mmHg, measured indirectly by intra-vesical pressure, and a multiple organ failure due to the raise of the intra abdominal pressure.

IAH, which is defined as an abdominal pressure rise above 12 mmHg, does not systematically lead to ACS, and is often successfully cured with medical therapy.

When medial management fails, or ACS is present, surgical management is appropriate and consists in a decompressive laparotomy.

CT examination is not ordered for ACS diagnostic, but radiologists should be aware of this condition and CT findings in patients with IAH, as these critically ill patients are likely to have multiple CT examinations in a diagnostic purpose for the initial condition, its complications or its surveillance.

Several radiological studies have determined CT findings of IAH and ACS. Most of them failed to establish a specific and sensitive semiology of IAH, due to weak methodology (except Al-Bahrani and al.). The diagnostic significance of the "Round Belly Sign" (RBS), first described by Pickhardt and al., has been debated since. None of these studies evaluated the prognostic value of IAH CT findings.

Some of IAH CT findings may have a prognostic value, and being statistically linked to a
Sponsor: Centre Hospitalier Universitaire de Besancon

Current Primary Outcome:

• Intra abdominal hypertension (HIA) [ Time Frame: Within four hours before or after the abdominal CT examination ]
  Incidence of intra-abdominal hypertension in patients included, defined by the raise above 12 mmHg of the intra-vesical pressure measured in a standardized way
• Round Belly Sign [ Time Frame: At the time of CT examination ]
  Increased ratio of anteroposterior/transverse diameter of the abdomen (ratio >0.80), measured at the level where left renal vein crosses the aorta, excluding subcutaneous fat.

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Narrowing of abdomen large veins [ Time Frame: At the time of CT examination ]
  Defined as a slit-like appearance of less than 3 mm
• Elevation of the diaphragm [ Time Frame: At the time of CT examination ]
  Defined as dome of diaphragm reaching the 10th thoracic vertebral body or above
• Compression or displacement of solid abdominal viscera [ Time Frame: At the time of CT examination ]
  Presence of contour deformity
• Bowel wall thickening with contrast enhancement [ Time Frame: At the time of CT examination ]
  Defined as a thickness of 3 mm or greater with contrast enhancement
• Bilateral inguinal herniation [ Time Frame: At the time of CT examination ]
  Bilateral inguinal herniation, if not present on a previous imaging examination
• Increase of the peritoneal/abdominal ratio [ Time Frame: At the time of CT examination ]
  Increase of the peritoneal/abdominal height ratio (ratio > 0,5). Peritoneal compartment height is measured from posterior third duodenum wall on the median line to the abdominal anterior wall. Abdominal compartment height is measured at the same level, excluding subcutaneous fat.
• Semi lunar line distension [ Time Frame: At the time of CT examination ]
  The longer length between transverse abdominis muscle and rectus abdominis muscle in millimeter
• Concavity of the upper side of the para renal fascia [ Time Frame: At the time of CT examination ]
  Concave deformity of the upper side of the para renal fascia, with or without renal deformity or displacement
• Abdominal Compartment Syndrome (ACS) [ Time Frame: From the time of inclusion to 28 days after ]
  Incidence of ACS in included patients, defined by a sustained intra abdominal hypertension above 20 mmHg and a multiple organ failure due to the raise of the intra abdominal pressure

Original Secondary Outcome: Same as current

Information By: Centre Hospitalier Universitaire de Besancon

Dates:
Date Received: June 16, 2016
Date Started: July 2016
Date Completion: July 2017
Last Updated: July 20, 2016
Last Verified: July 2016