Intra-Abdominal HypertensionSCANAPIVNCT02814734
Abdominal Compartment Syndrome : Diagnostic and Prognostic Value of CT Findings - a Prospective Study
An observational study of Intra-Abdominal Hypertension and Abdominal Compartment Syndrome, run by Centre Hospitalier Universitaire de Besancon.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intra-Abdominal Hypertension, Abdominal Compartment Syndrome
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- Jul 2016to Jul 2017
- 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: 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.
Who may be able to join
- 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
Who cannot join
- Age under 18 years
- Pregnancy
- Contraindication to urethral catheter
- Decompressive laparotomy before CT examination
- Absolute contraindication to CT enhancement agent
- Cystectomy
- Trusteeship/guardianship
About this study
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.
Read more
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.
Read the detailed description
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 raised risk of ACS overcome when found in at-risk patients population, with proven IAH.
The aim of this study is to evaluate diagnostic and prognostic value of CT findings in IAH in a prospective way, with a high statistic value.
These CT findings are the ones previously described in previous reviews (round belly sign, narrowing of abdominal veins, elevation of the diaphragm, bilateral inguinal herniation, bowel wall thickening with enhancement, direct visceral compression) and the ones studied here for the first time (increase of the peritoneal/abdominal ratio, semi-lunar line distension, concavity of the upper side of the para renal fascia).
Design:
For each included patient, when an abdominal CT is ordered, an intra-abdominal pressure measure is performed simultaneously to the CT examination. Presence or absence of IAH or ACS is noted.
Two radiologists (one junior and one senior specialized in abdominal emergencies imaging) review the CT examinations and note the presence or absence of the ten CT features studied, without knowing the intra-abdominal pressure value.
Patient follow-up:
- 5 days follow-up
- intra-abdominal pressure measurements
- Incidence of ACS from the time of inclusion to 28 days after.
- Evolution of organ failures
- Vital status at 28 days
- Medical and surgical therapy applied
Analysis:
- Diagnostic value of CT findings in IAH
- Prognostic value of CT findings in IAH, defining CT features statistically linked to ACS overcome, and mortality at 28 days
Prevalence of IAH is expected to be about 40 to 50% in patients in state of shock hosted in ICU. Among them, about 20% are expected to suffer from ACS.
Sensitivity of RBS in IAH is about 80% according to Al-Bahrani and al.. To evaluate the diagnostic value of RBS with (CI = [0,68 - 0,88]), 68 cases of IAH and about 140 patients included are needed.
Based on imaging habits in our center, length of this study is expected to be about 10 months.
- Keywords
- Intra-Abdominal Hypertension, Abdominal Compartment Syndrome, Round Belly Sign, Radiology, CT findings, Intensive Care
- Medical subject headings
- Intra-Abdominal Hypertension
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: At the time of CT examination
Secondary outcomes (9)
Narrowing of abdomen large veins
Defined as a slit-like appearance of less than 3 mm
Measured: At the time of CT examination
Elevation of the diaphragm
Defined as dome of diaphragm reaching the 10th thoracic vertebral body or above
Measured: At the time of CT examination
Compression or displacement of solid abdominal viscera
Presence of contour deformity
Measured: At the time of CT examination
Bowel wall thickening with contrast enhancement
Defined as a thickness of 3 mm or greater with contrast enhancement
Measured: At the time of CT examination
Bilateral inguinal herniation
Bilateral inguinal herniation, if not present on a previous imaging examination
Measured: At the time of CT examination
Increase of the peritoneal/abdominal ratio
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.
Measured: At the time of CT examination
Semi lunar line distension
The longer length between transverse abdominis muscle and rectus abdominis muscle in millimeter
Measured: At the time of CT examination
Concavity of the upper side of the para renal fascia
Concave deformity of the upper side of the para renal fascia, with or without renal deformity or displacement
Measured: At the time of CT examination
Abdominal Compartment Syndrome (ACS)
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
Measured: From the time of inclusion to 28 days after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2016 (estimated)
- Study startJul 2016
- Primary completionJul 2016 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Intra-Abdominal HypertensionStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02814734
- Sponsor's protocol ID
- P/2016/298
- Acronym
- SCANAPIV
- Status last verified
- Jul 2016
- First submitted
- 16 Jun 2016
- Last updated
- 21 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 22720147Malbrain 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.
PubMed 25973659Patel 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.
PubMed 17954637Epelman 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.
PubMed 11956717Al-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.
PubMed 17556037Malbrain 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.
PubMed 24603146Atema 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.
PubMed 24368386Wu 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.
PubMed 25622665Iyer 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.
PubMed 25307712De 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.
PubMed 25973660Wachsberg 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.
PubMed 9437074Hong 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.
PubMed 11972549Malbrain 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.
PubMed 16967294Holodinsky 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.
PubMed 24144138
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abdominal Compartment Syndrome : Diagnostic and Prognostic Value of CT Findings - a Prospective Study
- ClinicalTrials.gov ID
- NCT02814734
- Acronym / sponsor ID
- SCANAPIV / P/2016/298
- Keywords
- Intra-Abdominal Hypertension, Abdominal Compartment Syndrome, Round Belly Sign, Radiology, CT findings, Intensive Care
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 28 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 description
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 raised risk of ACS overcome when found in at-risk patients population, with proven IAH.
The aim of this study is to evaluate diagnostic and prognostic value of CT findings in IAH in a prospective way, with a high statistic value.
These CT findings are the ones previously described in previous reviews (round belly sign, narrowing of abdominal veins, elevation of the diaphragm, bilateral inguinal herniation, bowel wall thickening with enhancement, direct visceral compression) and the ones studied here for the first time (increase of the peritoneal/abdominal ratio, semi-lunar line distension, concavity of the upper side of the para renal fascia).
Design:
For each included patient, when an abdominal CT is ordered, an intra-abdominal pressure measure is performed simultaneously to the CT examination. Presence or absence of IAH or ACS is noted.
Two radiologists (one junior and one senior specialized in abdominal emergencies imaging) review the CT examinations and note the presence or absence of the ten CT features studied, without knowing the intra-abdominal pressure value.
Patient follow-up:
- 5 days follow-up
- intra-abdominal pressure measurements
- Incidence of ACS from the time of inclusion to 28 days after.
- Evolution of organ failures
- Vital status at 28 days
- Medical and surgical therapy applied
Analysis:
- Diagnostic value of CT findings in IAH
- Prognostic value of CT findings in IAH, defining CT features statistically linked to ACS overcome, and mortality at 28 days
Prevalence of IAH is expected to be about 40 to 50% in patients in state of shock hosted in ICU. Among them, about 20% are expected to suffer from ACS.
Sensitivity of RBS in IAH is about 80% according to Al-Bahrani and al.. To evaluate the diagnostic value of RBS with (CI = [0,68 - 0,88]), 68 cases of IAH and about 140 patients included are needed.
Based on imaging habits in our center, length of this study is expected to be about 10 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- Age under 18 years
- Pregnancy
- Contraindication to urethral catheter
- Decompressive laparotomy before CT examination
- Absolute contraindication to CT enhancement agent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
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.
9 secondary outcomes
Narrowing of abdomen large veins
Time frame: At the time of CT examination
Elevation of the diaphragm
Time frame: At the time of CT examination
Compression or displacement of solid abdominal viscera
Time frame: At the time of CT examination
Bowel wall thickening with contrast enhancement
Time frame: At the time of CT examination
Bilateral inguinal herniation
Time frame: At the time of CT examination
Increase of the peritoneal/abdominal ratio
Time frame: At the time of CT examination
Semi lunar line distension
Time frame: At the time of CT examination
Concavity of the upper side of the para renal fascia
Time frame: At the time of CT examination
Abdominal Compartment Syndrome (ACS)
Time frame: From the time of inclusion to 28 days after
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2016.
- Background: PubMed 22720147Luckianow 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.
- Background: PubMed 25973659Malbrain 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.
- Background: PubMed 17954637Patel 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.
- Background: PubMed 11956717Epelman 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.
- Background: PubMed 17556037Al-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.
- Background: PubMed 24603146Malbrain 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.
- Background: PubMed 24368386Atema 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.
- Background: PubMed 25622665Wu 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.
- Background: PubMed 25307712Iyer 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.
- Background: PubMed 25973660De 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.
- Background: PubMed 9437074Wachsberg 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.
- Background: PubMed 11972549Hong 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Intra-Abdominal Hypertension and Abdominal Compartment Syndrome, run by Centre Hospitalier Universitaire de Besancon.
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 5 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 21 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Intra abdominal hypertension (HIA) (time frame: Within four hours before or after the abdominal CT examination). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02814734, which also lists 14 linked publications.
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 21 Jul 2016.