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WORLD SOCIETY OF THE |
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WORLD SOCIETY OF THE |
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The Clinical Trials Working Group (CTWG) of the World Society on Abdominal Compartment Syndrome (WSACS) sponsors high-quality research and education in the fields of intra-abdominal hypertension (IAH) and abdominal compartment syndrome (ACS). If you are interested in participating in CTWG-sponsored research trials, please complete the CTWG Investigator Interest Form so that we may keep you updated as to the status of CTWG-sponsored research,
The clinical trials listed below are currently recruiting patients. Investigators who are interested in becoming a study site for one or more of these studies should contact the Primary Investigator listed for each trial.
Please contact the CTWG chairman Dr. Jan DeWaele with any questions or concerns regarding these studies.
| Trial Number | WSACS002 |
| Date Submitted | 29 August 2006 |
| Title | Abdominal Hypertension and Rectus Sheath or Retroperitoneal Hematoma: A Multicenter Retrospective Analysis |
| Primary Investigator | Manu Malbrain, MD |
| Contact Email | manu.malbrain@skynet.be |
| Summary | Rectus sheath or retroperitoneal hematoma is a well recognised complication of treatment with low molecular weight heparin (LMWH) or oral anticoagulation, but can also be caused by trauma, after surgery, with pregnancy or just spontaneously. Increased intra-abdominal pressure (IAP) and abdominal compartment syndrome (ACS) have recently been reported as a complication of LMWH-associated rectus sheath hematoma and in some cases surgical evacuation resulted in improvement of organ function. Primary objective: To determine the effect of intervention/surgery on the clinical course of patients with rectus sheath or retroperitoneal hematoma. Secondary objective: To determine the clinical course of patients with rectus sheath or retroperitoneal hematoma without decompressive surgery. |
| Documentation | Study Synopsis |
| Trial Number | WSACS005 |
| Date Submitted | 27 March 2008 |
| Title | Prospective, Randomized Trial of Abdominal Perfusion Pressure (APP) as a Resuscitation Endpoint
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| Primary Investigator | Michael Cheatham, MD |
| Contact Email | michael.cheatham@orhs.org |
| Summary | A prospective, randomized, non-blinded resuscitation endpoint trial to determine whether maintenance of abdominal perfusion pressure (APP) 60 mmHg improves survival in patients with either moderate intra-abdominal hypertension (IAH) or abdominal compartment syndrome (ACS) when compared to a traditional mean arterial pressure (MAP) resuscitation endpoint of 65 mmHg. |
| Documentation | Study Synopsis |
| Trial Number | WSACS007 |
| Date Submitted | 11 March 2008 |
| Title | A multicenter observational study on the effect of decompressive laparotomy for abdominal compartment syndrome.
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| Primary Investigator | Jan De waele, PhD |
| Contact Email | jan.dewaele@UGent.be |
| Summary | A prospective observational study to determine the effect of decompressive laparotomy on outcome (subject mortality, organ dysfunction and laparotomy related morbidity). |
| Documentation | Study Synopsis |
| Trial Number | WSACSWSACS0014 |
| Date Submitted | 23 April 2009 |
| Title | Are elevated intra-abdominal pressures associated with non invasive ventilation? |
| Primary Investigator | Bart De keulenaer, MD |
| Contact Email | bdekeul@hotmail.com |
| Summary | Non-invasive positive pressure ventilation has been successfully used in a variety of clinical conditions and early use has been associated with improved outcome in certain pathologies. Failure of NIPPV often results in mechanical ventilation which will increase morbidity and mortality. NIPPV can induce aerophagia subsequently leading to increased IAP. Normally the lower gastro-oesophageal sfincter pressure (LOSP)should be protective against air entering into the stomach but in the critically ill this LOSP seems to be variable. Therefore, failure of NIPPV can be a result of increasing IAP (leading to IAH and even ACS) in patients started on NIPPV. |
| Documentation | Study Synopsis |
| Trial Number | WSACSWSACS0015 |
| Date Submitted | 03 June 2009 |
| Title | Prospective Trial of
Percutaneous Catheter Decompression in the Treatment of Elevated Intra-abdominal Pressure
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| Primary Investigator | Michael Cheatham, MD |
| Contact Email | michael.cheatham@orlandohealth.com |
| Summary | Percutaneous catheter decompression (PCD)is described in the current World Society of the Abdominal Compartment Syndrome (WSACS) consensus recommendations as an option for IAH / ACS treatment, but insufficient evidence exists to support any form of evidence-based recommendation at this time. The clinical validity of PCD as a therapeutic tool therefore needs to be evaluated in a prospective multicenter trial. This study would confirm whether 1) PCD decreases IAP in comparison to the currently recommended treatment modalities, and 2) PCD decreases the development of IAH-induced organ dysfunction and failure. If such findings are confirmed, this study would support the development of evidence-based recommendations regarding PCD as a therapeutic tool in future revisions of the WSACS guidelines. |
| Documentation | Study Synopsis |
| Trial Number | 001 |
| Date Submitted | 16 June 2006 |
| Title | The Effect of Body Positioning on Intra-Abdominal Pressure Measurement: A Multicenter Analysis |
| Primary Investigator | Michael L. Cheatham MD, Jan J. DeWaele MD, |
| Contact Email | michael.cheatham@orhs.org |
| Summary |
| Trial Number | 003 |
| Date Submitted | 29 August 2006 |
| Title | Survey on the Clinical Awareness of Intra-abdominal Hypertension (IAH) and the Abdominal Compartment Syndrome (ACS) in Critically Ill Patients |
| Primary Investigator | WSACS Executive Committee, |
| Contact Email | webmaster@wsacs.org |
| Summary | This survey is designed to assess the clinical awareness of IAH and ACS in intensive care units and emergency departments around the world, and to determine when and how IAP is measured and IAH and ACS are managed. Although there is strong evidence supporting the deleterious effects of increased intra-abdominal pressure (IAP), intra-abdominal hypertension (IAH), and abdominal compartment syndrome (ACS) in different patient populations, the measurement of IAP is not yet universally applied even among those patients where the evidence is most strong. The WSACS Executive Committee has created an interactive online survey to characterise the current worldwide understanding and application of IAP monitoring and management of IAH and ACS among multidisciplinary critical care providers. This survey has been endorsed by the European Society of Intensive Care Medicine (ESICM) and is approved by the Orlando Regional Healthcare Institutional Review Board. |
| Trial Number | 008 |
| Date Submitted | 09 April 2008 |
| Title | A Multicenter Observational Study on the Incidence of Intra-abdominal Hypertension in Patients with Severe Acute Pancreatitis and its Effect on Outcome (SPIRIT Study - Severe Pancreatitis and IntRaabdomInal
hyperTension) |
| Primary Investigator | Jan De waele, PhD |
| Contact Email | jan.dewaele@UGent.be |
| Summary | A prospective, observational trial to determine the incidence of intraabdominal hypertension in patients with severe acute pancreatitis, and evaluate the effect of the presence of intraabdominal hypertension on outcome (subject mortality, organ dysfunction, infection of pancreatic necrosis, requirement of surgical intervention). |
| Trial Number | 009 |
| Date Submitted | 10 April 2008 |
| Title | Comparing Iliac/Inferior Vena Cava Venous Pressure Monitoring with Standard Intra-abdominal Pressure Measurements via the Bladder. |
| Primary Investigator | Bart De keulenaer, MD |
| Contact Email | bdekeul@hotmail.com |
| Summary | A multicentre observational study to compare iliac/inferior vena cava venous pressure monitoring with standard intra-abdominal pressure measurements via the bladder. |
| Trial Number | 013 |
| Date Submitted | 08 May 2009 |
| Title | Prospective, Observational, Multicenter Study of Gastrointestinal Dysfunction in Critically Ill Patients. Development of Gastrointestinal Failure Score. |
| Primary Investigator | Annika Reintam, PhD |
| Contact Email | annika.reintam@ut.ee |
| Summary | Present study evaluates the different variations of possible gastrointestinal failure (GIF) score by their prognostic value in prediction of ICU and 28-day mortality in adult, mechanically ventilated critically ill patients. Consecutive patients, admitted to the ICU during one week will be studied; the SOFA score, precisely defined GI symptoms, food intolerance/underfeeding, intra-abdominal pressure (IAP) and abdominal perfusion pressure (APP) will be documented. The patients will thereafter be followed for outcome for 28 days, and prognostic value for GI symptoms, food intolerance/underfeeding and IAP/APP on the 28-day survival will be evaluated. Variables (GI symptoms, underfeeding and IAH/APP) with greatest impact, i.e. independent risk factors of mortality will be identified and combined into new 5 grade GIF score, build up of which follows the logic of organ failure sub-scores in SOFA score. The following analysis will investigate the predictive power of possible scores to identify the best GIF score. |