NCT07563842

Brief Summary

An international team of experts is working on a project called updated WSACS consensus definitions. The goals of this study are to:

  1. 1.To generate expert consensus on the definitions and classification of IAH and ACS.
  2. 2.To generate expert consensus on definitions regarding the pathophysiology of IAH and ACS.
  3. 3.To generate consensus on definitions regarding the methods of measurement of intra-abdominal pressure (IAP).

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
3mo left

Started Oct 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress71%
Oct 2025Jul 2026

Study Start

First participant enrolled

October 13, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 8, 2026

Completed
4 months until next milestone

First Posted

Study publicly available on registry

May 4, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2026

Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

10 months

First QC Date

January 8, 2026

Last Update Submit

April 30, 2026

Conditions

Keywords

abdominal hypertensionabdominal compartment syndromedefinitionspathophysiologymeasurementintra-abdominal pressureintra-abdominal volume

Outcome Measures

Primary Outcomes (1)

  • Level of consensus on definitions of intra-abdominal hypertension (IAH) and abdominal compartment syndrome (ACS)

    Proportion of predefined definition statements for IAH and ACS reaching consensus among expert panellists, measured using a structured Delphi process. Consensus is defined a priori as ≥80% agreement on a 5-point Likert scale (ratings of 4-5 indicating agreement). Outcomes will include: Number and percentage of statements reaching consensus Median and interquartile range (IQR) of Likert scores per statement Stability of responses across Delphi rounds

    3-6 months

Secondary Outcomes (2)

  • Level of consensus on pathophysiological concepts of IAH and ACS

    3-6 months

  • Level of consensus on measurement methods for intra-abdominal pressure (IAP)

    3-6 months

Study Arms (1)

Panelist

Other: Delphi study

Interventions

structured interview via online survey

Panelist

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Inclusion Criteria: Panellists will be identified based on either of the following criteria At least 5 years of clinical experience as a staff member in Anesthesiology, Surgery or Intensive Care Medicine with involvement in care of patients with postoperative complications Author of at least one publication (observational studies or randomised controlled trials) on intra-abdominal hypertension or abdominal compartment syndrome. For patients and public involvement Individuals who have either personally experienced IAH or ACS following surgery or ICU within the last 5 years or, primary caregivers of such patients will be recruited as patient care representatives. Proficiency in English is required. To mitigate potential bias, patient care representatives mustn't maintain a professional or advisory relationship with the steering committee or panellists. Co-authors from previous WSACS survey published in 2024, former or current WSACS ambassadors, representative from WSES, ESAIC, ES

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Lublin

Lublin, 20090, Poland

Location

Related Publications (27)

  • Alhazzani W, Lewis K, Jaeschke R, Rochwerg B, Møller MH, Evans L, et al. Conflicts of interest disclosure forms and management in critical care clinical practice guidelines. Intensive Care Med. 2018;44(10):1691-8.

    BACKGROUND
  • Traversy G, Barnieh L, Akl EA, Allan GM, Brouwers M, Ganache I, et al. Managing conflicts of interest in the development of health guidelines. CMAJ. 2021;193(2):E49-E54.

    BACKGROUND
  • Schünemann HJ, Al-Ansary LA, Forland F, Kersten S, Komulainen J, Kopp IB, et al. Guidelines International Network: Principles for Disclosure of Interests and Management of Conflicts in Guidelines. Ann Intern Med. 2015;163(7):548-53.

    BACKGROUND
  • Gattrell WT, Logullo P, van Zuuren EJ, Price A, Hughes EL, Blazey P, et al. ACCORD (ACcurate COnsensus Reporting Document): A reporting guideline for consensus methods in biomedicine developed via a modified Delphi. PLoS Med. 2024;21(1):e1004326.

    BACKGROUND
  • Nasa P, Jain R, Juneja D. Delphi methodology in healthcare research: How to decide its appropriateness. World J Methodol. 2021 Jul 20;11(4):116-129. doi: 10.5662/wjm.v11.i4.116. eCollection 2021 Jul 20.

    PMID: 34322364BACKGROUND
  • Nasa P, Azoulay E, Khanna AK, Jain R, Gupta S, Javeri Y, et al. Expert consensus statements for the management of COVID-19-related acute respiratory failure using a Delphi method. Crit Care. 2021;25(1):106.

    BACKGROUND
  • Page MJ, McKenzie JE, Bossuyt PM, Boutron I, Hoffmann TC, Mulrow CD, Shamseer L, Tetzlaff JM, Akl EA, Brennan SE, Chou R, Glanville J, Grimshaw JM, Hrobjartsson A, Lalu MM, Li T, Loder EW, Mayo-Wilson E, McDonald S, McGuinness LA, Stewart LA, Thomas J, Tricco AC, Welch VA, Whiting P, Moher D. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ. 2021 Mar 29;372:n71. doi: 10.1136/bmj.n71.

    PMID: 33782057BACKGROUND
  • Nasa P, Wise RD, Smit M, Acosta S, D'Amours S, Beaubien-Souligny W, et al. International cross-sectional survey on current and updated definitions of intra-abdominal hypertension and abdominal compartment syndrome. World J Emerg Surg. 2024;19(1):39.

    BACKGROUND
  • Roberts DJ, Zygun DA, Kirkpatrick AW, Ball CG, Faris PD, Bobrovitz N, et al. A protocol for a scoping and qualitative study to identify and evaluate indications for damage control surgery and damage control interventions in civilian trauma patients. BMJ Open. 2014;4(7):e005634.

    BACKGROUND
  • Higa G, Friese R, O'Keeffe T, Wynne J, Bowlby P, Ziemba M, et al. Damage control laparotomy: a vital tool once overused. J Trauma. 2010;69(1):53-9.

    BACKGROUND
  • Miller RS, Morris JA Jr, Diaz JJ Jr, Herring MB, May AK. Complications after 344 damage-control open celiotomies. J Trauma. 2005 Dec;59(6):1365-71; discussion 1371-4. doi: 10.1097/01.ta.0000196004.49422.af.

    PMID: 16394910BACKGROUND
  • van Brunschot S, Schut AJ, Bouwense SA, Besselink MG, Bakker OJ, van Goor H, et al. Abdominal compartment syndrome in acute pancreatitis: a systematic review. Pancreas. 2014;43(5):665-74.

    BACKGROUND
  • Strang SG, Van Lieshout EM, Breederveld RS, Van Waes OJ. A systematic review on intra-abdominal pressure in severely burned patients. Burns. 2014 Feb;40(1):9-16. doi: 10.1016/j.burns.2013.07.001. Epub 2013 Sep 17.

    PMID: 24050978BACKGROUND
  • Karkos CD, Menexes GC, Patelis N, Kalogirou TE, Giagtzidis IT, Harkin DW. A systematic review and meta-analysis of abdominal compartment syndrome after endovascular repair of ruptured abdominal aortic aneurysms. J Vasc Surg. 2014 Mar;59(3):829-42. doi: 10.1016/j.jvs.2013.11.085. Epub 2014 Jan 16.

    PMID: 24439324BACKGROUND
  • Malbrain ML, Chiumello D, Cesana BM, Reintam Blaser A, Starkopf J, Sugrue M, et al. 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;80(3):293-306.

    BACKGROUND
  • Moll V, Khanna AK, Kurz A, Huang J, Smit M, Swaminathan M, et al. Optimization of kidney function in cardiac surgery patients with intra-abdominal hypertension: expert opinion. Perioper Med (Lond). 2024;13(1):72.

    BACKGROUND
  • Reintam Blaser A, Regli A, De Keulenaer B, Kimball EJ, Starkopf L, Davis WA, 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;47(4):535-42.

    BACKGROUND
  • Regli A, Reintam Blaser A, De Keulenaer B, Starkopf J, Kimball E, Malbrain M, et al. Intra-abdominal hypertension and hypoxic respiratory failure together predict adverse outcome - A sub-analysis of a prospective cohort. J Crit Care. 2021;64:165-72.

    BACKGROUND
  • Strang SG, Van Lieshout EM, Van Waes OJ, Verhofstad MH. Prevalence and mortality of abdominal compartment syndrome in severely injured patients: A systematic review. J Trauma Acute Care Surg. 2016 Sep;81(3):585-92. doi: 10.1097/TA.0000000000001133.

    PMID: 27398983BACKGROUND
  • Kirkpatrick AW, Roberts DJ, De Waele J, Jaeschke R, Malbrain ML, De Keulenaer B, et al. Intra-abdominal hypertension and the abdominal compartment syndrome: updated consensus definitions and clinical practice guidelines from the World Society of the Abdominal Compartment Syndrome. Intensive Care Med. 2013;39(7):1190-206.

    BACKGROUND
  • De Waele JJ, Cheatham ML, Malbrain MLNG, Kirkpatrick A, Sugrue M, Balogh Z, et al. Recommendations for research from the International Conference of Experts on Intra-abdominal Hypertension and Abdominal Compartment Syndrome. Acta Clin Belg. 2009;64(3):203-9.

    BACKGROUND
  • Cheatham ML. Nonoperative management of intraabdominal hypertension and abdominal compartment syndrome. World J Surg. 2009 Jun;33(6):1116-22. doi: 10.1007/s00268-009-0003-9.

    PMID: 19363690BACKGROUND
  • Cheatham ML, Malbrain ML, Kirkpatrick A, Sugrue M, Parr M, De Waele J, et al. Results from the International Conference of Experts on Intra-abdominal Hypertension and Abdominal Compartment Syndrome. II. Recommendations. Intensive Care Med. 2007;33(6):951-62.

    BACKGROUND
  • Malbrain ML, De laet I, Cheatham M. Consensus conference definitions and recommendations on intra-abdominal hypertension (IAH) and the abdominal compartment syndrome (ACS)--the long road to the final publications, how did we get there? Acta Clin Belg Suppl. 2007;62(1):44-59.

    BACKGROUND
  • Malbrain ML, Cheatham ML, Kirkpatrick A, Sugrue M, Parr M, De Waele J, et al. Results from the International Conference of Experts on Intra-abdominal Hypertension and Abdominal Compartment Syndrome. I. Definitions. Intensive Care Med. 2006;32(11):1722-32.

    BACKGROUND
  • Murphy PB, Parry NG, Sela N, Leslie K, Vogt K, Ball I. Intra-Abdominal Hypertension Is More Common Than Previously Thought: A Prospective Study in a Mixed Medical-Surgical ICU. Crit Care Med. 2018;46(6):958-64.

    BACKGROUND
  • Blaser AR, Sarapuu S, Tamme K, Starkopf J. Expanded measurements of intra-abdominal pressure do not increase the detection rate of intra-abdominal hypertension: a single-center observational study. Crit Care Med. 2014;42(2):378-86.

    BACKGROUND

Related Links

MeSH Terms

Conditions

Intra-Abdominal Hypertension

Condition Hierarchy (Ancestors)

Compartment SyndromesMuscular DiseasesMusculoskeletal DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Prashant Nasa, MD

    The Royal Wolverhampton NHS Trust Wolverhampton, UK

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Critical Care Research

Study Record Dates

First Submitted

January 8, 2026

First Posted

May 4, 2026

Study Start

October 13, 2025

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

July 31, 2026

Last Updated

May 4, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

The IPD is available to investigators and can be shared with appropriate requests.

Locations