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

NCT02814734 | Unknown

• 1 other identifier: P/2016/298
• Study Type: observational
• Target: 140
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Intra-Abdominal Hypertension; Abdominal Compartment Syndrome

Keywords

Intra-Abdominal Hypertension; Abdominal Compartment Syndrome; Round Belly Sign; Radiology; CT findings; Intensive Care

Outcome Measures

Primary Outcomes (2)

• Intra abdominal hypertension (HIA)

  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

  Within four hours before or after the abdominal CT examination

• Round Belly Sign

  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.

  At the time of CT examination

Secondary Outcomes (9)

• Narrowing of abdomen large veins

  At the time of CT examination

• Elevation of the diaphragm

  At the time of CT examination

• Compression or displacement of solid abdominal viscera

  At the time of CT examination

• Bowel wall thickening with contrast enhancement

  At the time of CT examination

• Bilateral inguinal herniation

  At the time of CT examination

Eligibility Criteria

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

Study Population

Critically ill patients hosted in intensive care units (ICU) in state of shock requiring vasopressive drugs, mechanical ventilation, in which an abdominal CT is ordered and performed with simultaneous intra abdominal pressure measurement.

You may qualify if:

• Critically ill patients requiring ICU hosting
• State of shock requiring vasopressive drugs
• State of shock requiring mechanical ventilation
• Abdominal CT examination ordered
• Intra abdominal pressure measurement

You may not qualify if:

• Age under 18 years
• Pregnancy
• Contraindication to urethral catheter
• Decompressive laparotomy before CT examination
• Absolute contraindication to CT enhancement agent
• Cystectomy
• Trusteeship/guardianship

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead

Related Publications (14)

• Luckianow GM, Ellis M, Governale D, Kaplan LJ. Abdominal compartment syndrome: risk factors, diagnosis, and current therapy. Crit Care Res Pract. 2012;2012:908169. doi: 10.1155/2012/908169. Epub 2012 Jun 7.

  PMID: 22720147 BACKGROUND

• Malbrain ML, De Keulenaer BL, Oda J, De Laet I, De Waele JJ, Roberts DJ, Kirkpatrick AW, Kimball E, Ivatury R. Intra-abdominal hypertension and abdominal compartment syndrome in burns, obesity, pregnancy, and general medicine. Anaesthesiol Intensive Ther. 2015;47(3):228-40. doi: 10.5603/AIT.a2015.0021. Epub 2015 May 14.

  PMID: 25973659 BACKGROUND

• Patel A, Lall CG, Jennings SG, Sandrasegaran K. Abdominal compartment syndrome. AJR Am J Roentgenol. 2007 Nov;189(5):1037-43. doi: 10.2214/AJR.07.2092.

  PMID: 17954637 BACKGROUND

• Epelman M, Soudack M, Engel A, Halberthal M, Beck R. Abdominal compartment syndrome in children: CT findings. Pediatr Radiol. 2002 May;32(5):319-22. doi: 10.1007/s00247-001-0569-3. Epub 2002 Feb 15.

  PMID: 11956717 BACKGROUND

• Al-Bahrani AZ, Abid GH, Sahgal E, O'shea S, Lee S, Ammori BJ. A prospective evaluation of CT features predictive of intra-abdominal hypertension and abdominal compartment syndrome in critically ill surgical patients. Clin Radiol. 2007 Jul;62(7):676-82. doi: 10.1016/j.crad.2006.11.006. Epub 2007 May 2.

  PMID: 17556037 BACKGROUND

• Malbrain ML, Chiumello D, Cesana BM, Reintam Blaser A, Starkopf J, Sugrue M, Pelosi P, Severgnini P, Hernandez G, Brienza N, Kirkpatrick AW, Schachtrupp A, Kempchen J, Estenssoro E, Vidal MG, De Laet I, De Keulenaer BL; WAKE-Up! Investigators. A systematic review and individual patient data meta-analysis on intra-abdominal hypertension in critically ill patients: the wake-up project. World initiative on Abdominal Hypertension Epidemiology, a Unifying Project (WAKE-Up!). Minerva Anestesiol. 2014 Mar;80(3):293-306. Epub 2013 Dec 12.

  PMID: 24603146 BACKGROUND

• Atema JJ, van Buijtenen JM, Lamme B, Boermeester MA. Clinical studies on intra-abdominal hypertension and abdominal compartment syndrome. J Trauma Acute Care Surg. 2014 Jan;76(1):234-40. doi: 10.1097/TA.0b013e3182a85f59. No abstract available.

  PMID: 24368386 BACKGROUND

• Wu J, Zhu Q, Zhu W, Chen W, Wang S. [Computed tomographic features of abdominal compartment syndrome complicated by severe acute pancreatitis]. Zhonghua Yi Xue Za Zhi. 2014 Nov 25;94(43):3378-81. Chinese.

  PMID: 25622665 BACKGROUND

• Iyer D, Rastogi P, Aneman A, D'Amours S. Early screening to identify patients at risk of developing intra-abdominal hypertension and abdominal compartment syndrome. Acta Anaesthesiol Scand. 2014 Nov;58(10):1267-75. doi: 10.1111/aas.12409.

  PMID: 25307712 BACKGROUND

• De Waele JJ, Ejike JC, Leppaniemi A, De Keulenaer BL, De Laet I, Kirkpatrick AW, Roberts DJ, Kimball E, Ivatury R, Malbrain ML. Intra-abdominal hypertension and abdominal compartment syndrome in pancreatitis, paediatrics, and trauma. Anaesthesiol Intensive Ther. 2015;47(3):219-27. doi: 10.5603/AIT.a2015.0027. Epub 2015 May 14.

  PMID: 25973660 BACKGROUND

• Wachsberg RH, Sebastiano LL, Levine CD. Narrowing of the upper abdominal inferior vena cava in patients with elevated intraabdominal pressure. Abdom Imaging. 1998 Jan-Feb;23(1):99-102. doi: 10.1007/s002619900295.

  PMID: 9437074 BACKGROUND

• Hong JJ, Cohn SM, Perez JM, Dolich MO, Brown M, McKenney MG. Prospective study of the incidence and outcome of intra-abdominal hypertension and the abdominal compartment syndrome. Br J Surg. 2002 May;89(5):591-6. doi: 10.1046/j.1365-2168.2002.02072.x.

  PMID: 11972549 BACKGROUND

• Malbrain ML, Cheatham ML, Kirkpatrick A, Sugrue M, Parr M, De Waele J, Balogh Z, Leppaniemi A, Olvera C, Ivatury R, D'Amours S, Wendon J, Hillman K, Johansson K, Kolkman K, Wilmer A. Results from the International Conference of Experts on Intra-abdominal Hypertension and Abdominal Compartment Syndrome. I. Definitions. Intensive Care Med. 2006 Nov;32(11):1722-32. doi: 10.1007/s00134-006-0349-5. Epub 2006 Sep 12.

  PMID: 16967294 BACKGROUND

• Holodinsky JK, Roberts DJ, Ball CG, Blaser AR, Starkopf J, Zygun DA, Stelfox HT, Malbrain ML, Jaeschke RC, Kirkpatrick AW. Risk factors for intra-abdominal hypertension and abdominal compartment syndrome among adult intensive care unit patients: a systematic review and meta-analysis. Crit Care. 2013 Oct 21;17(5):R249. doi: 10.1186/cc13075.

  PMID: 24144138 BACKGROUND

MeSH Terms

Conditions

Intra-Abdominal Hypertension

Condition Hierarchy (Ancestors)

Compartment Syndromes; Muscular Diseases; Musculoskeletal Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2016
• First Posted: June 28, 2016
• Study Start: July 1, 2016
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2017
• Last Updated: July 21, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share