Clinical Trials Working Group

Research

Date	April 7, 2021
Modified	April 7, 2021
Author	WSACS

Main (ultimate) task:

Promote, facilitate or conduct high quality experimental and clinical research relating to the abdominal compartment

Specific tasks:

Provide an overview on current trials (including non-WSACS trials) relating to the abdominal compartment
Define priority areas for further studies
Provide expertise in designing studies
Provide an overview of active researchers in the area of abdominal compartment, promote collaboration and invite non-WSACS to join where appropriate
Provide WSACS members a network of collaborators to promote their studies
Evaluate study proposals and provide endorsement with or without financial support to selected studies

Possible ways of WSACS support to endorsed studies

Endorsement – the study is conducted under the WSACS name and WSACS shares the responsibility for planning, conduction and publication of the study. If intellectual input by CTWG members during these processes is relevant (according to the ICJME guidelines for authorship), WSACS may ask one to two CTWG persons to be included as co-authors on the manuscript. WSACS will promote the study on WSACS web-pages, during congresses, etc. Such endorsement also applies to all following ways of support.
Endorsement with WSACS Grant – the sum will be defined yearly and agreed individually for each endorsed project. The sum for 2015 is 10,000 EUR and for 2016 another 10,000 EUR.
Endorsement with WSACS support on study coordination – for important large projects WSACS may provide a study coordinator 50% job paid by WSACS for strictly limited time period.
Endorsement with providing an electronic CRF

The Clinical Trials Working Group (CTWG) was founded by the World Society of the Abdominal Compartment Syndrome (www.www.wsacs.org) in 2004 to promote, support and stimulate research in the area of Intra-abdominal Hypertension (IAH) and Abdominal Compartment Syndrome (ACS). Dr Jan De Waele was our first CTWG Chairman, followed by Bart De Keulenaer. Under their mandate several multicentre studies were endorsed by the CTWG Committee (see table), most of them resulted in well-cited publications.

The mission of the WSACS has been to promote research, foster education, and improve the survival of patients with IAH/ACS. It should be considered as our success that within the last years the focus concerning ACS became less paramount, as ACS is becoming a more rare and less devastating syndrome. In order to reflect the evolving science and the need to widen our perspective, the World Society of the Abdominal Compartment Syndrome has officially changed its name to the WSACS – the Abdominal Compartment Society. Thereby a new, broader horizon is opening also for CTWG that now is dedicated to promote studies in all different aspects of the abdominal compartment.

CTWG today aims to shift our focus from small observational studies to multicentre interventional trials. CTWG is dedicated to support the investigators and achieve synergy with involvement of experts in study designing and co-operation with colleagues worldwide.

We encourage clinicians who have proposals for future research or want to participate in future trials of the WSACS to contact the new Chairman Dr Annika Reintam Blaser (annika.reintam.blaser@ut.ee).

Study number	Title	Principal investigator	Study status
WSACS 001a	The Impact of Body Positioning on Intra-Abdominal Pressure Measurement	Michael Cheatham	Published: Cheatham ML, De Waele JJ, De Laet I, et al. The impact of body position on intra-abdominal pressure measurement: a multicenter analysis. Crit Care Med. 2009 Jul;37(7):2187-90. doi: 10.1097/CCM.0b013e3181a021fa.
WSACS 001b	The effect of different reference transducer positions on intra-abdominal pressure measurement	Jan De Waele	Published: De Waele JJ, De Laet I, De Keulenaer B, et al. The effect of different reference transducer positions on intra-abdominal pressure measurement: a multicenter analysis. Intensive Care Med. 2008 Jul;34(7):1299-303. doi: 10.1007/s00134-008-1098-4.
WSACS 002	Effects of rectus sheath hematoma on IAP.	Manu Malbrain	Finished: manuscript in preparation
WSACS 003	Awareness and knowledge of intra-abdominal hypertension and abdominal compartment syndrome: results of an international survey.	Manu Malbrain	Published: Wise R, Roberts DJ, Vandervelden S, et al. Awareness and knowledge of intra-abdominal hypertension and abdominal compartment syndrome: results of an international survey. Anaesthesiol Intensive Ther. 2014 Oct 27. [Epub ahead of print]
WSACS 004	NA
WSACS 005	Abdominal perfusion pressure (APP) Trial	Michael Cheatham	Cancelled
WSACS 006	Randomized controlled trial comparing goal directed management vs standard care	Manu Malbrain	Protocol under construction
WSACS 007	A multicenter observational study on the effect of decompressive laparotomy for abdominal compartment syndrome	Jan De Waele	Finished, presented at ESICM 2014, manuscript in preparation
WSACS 008	SPIRIT Study – Severe Pancreatitis and IntRaabdomInal hyperTension	Jan De Waele	Finished: data analysis in process
WSACS 009	Femoral venous versus intrabladder abdominal pressure	Bart De Keulenaer	Published: De Keulenaer BL, Regli A, Dabrowski W, et al. Does femoral venous pressure measurement correlate well with intrabladder pressure measurement? A multicenter observational trial. Intensive Care Med. 2011 Oct;37(10):1620-7. doi: 10.1007/s00134-011-2298-x.
WSACS 010	NA
WSACS 011	Comparing intra-abdominal pressures in different body positions via a urinary catheter and nasogastric tube: a pilot study.	Bart De Keulenaer	Published: Rooban N1, Regli A, Davis WA, De Keulenaer BL. Comparing intra-abdominal pressures in different body positions via a urinary catheter and nasogastric tube: a pilot study. Ann Intensive Care. 2012 Jul 5;2 Suppl 1:S11. doi: 10.1186/2110-5820-2-S1-S11.
WSACS 012	Laparoscopy and IAH (LAP Trial)	Bart De Keulenaer	Finished: manuscript in preparation
WSACS 013	GIF (Gastro-Intestinal Failure) Trial	Annika Reintam Blaser	Published: Reintam Blaser A, Poeze M, Malbrain ML, et al. Gastrointestinal symptoms during the first week of intensive care are associated with poor outcome: a prospective multicentre study. Intensive Care Med. 2013 May;39(5):899-909. doi: 10.1007/s00134-013-2831-1.
WSACS 014	NIVIAH Trial – Are elevated intra-abdominal pressures associated with non invasive ventilation?	Bart De Keulenaer	Finished: manuscript submitted
WSACS 015	Prospective Trial of Percutaneous Catheter Decompression in the Treatment of Elevated Intra-abdominal Pressure	Michael Cheatham	Ongoing
WSACS 016	IROI Study: Incidence, prognosis and outcome of intra-abdominal hypertension.	Annika Reintam Blaser	Download IROI protocol Finished: Reintam Blaser A, Regli A, De Keulenaer B, et al. Incidence, Risk Factors, and Outcomes of Intra-Abdominal Hypertension in Critically Ill Patients-A Prospective Multicenter Study (IROI Study). Crit Care Med. 2019 Apr;47(4):535-542. doi: 10.1097/CCM.0000000000003623.Download IROI Respiratory substudy statistical plan
WSACS 017	American survey on IAH and ACS	Bruno Cesana	Finished: manuscript in preparation