Intra-Abdominal HypertensionWSACS-DELPHI-2NCT07915362
WSACS 2026 Delphi Consensus on the Practical Management of Intra-abdominal Hypertension and Abdominal Compartment Syndrome
An observational study of Intra-Abdominal Hypertension and Abdominal Compartment Syndrome, run by Medical University of Lublin at 1 site in Poland.
Trial summary
The Abdominal Compartment Society (WSACS) is updating its 2013 clinical practice guidelines on intra-abdominal hypertension (IAH) and the abdominal compartment syndrome (ACS). Systematic reviews informed the evidence-based recommendations and guidelines, but many practical bedside questions lack direct evidence. Read more about this study
- Who is it for?
- Ages 25 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intra-Abdominal Hypertension, Abdominal Compartment Syndrome
- What is being tested?
- Delphi structured interview via online survey
- How many people
- 70 participants
- Where
- 1 sitePoland
- Study dates
- 15 Nov 2026to 31 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 25 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: International multidisciplinary clinical and research experts with experience relevant to IAH/ACS: We accept All adults / accepts healthy volunteers (expert panelists, not patients)
Who may be able to join
- Clinicians or researchers in intensive care, emergency or trauma surgery, anaesthesia, paediatric critical care or nursing, with peer-reviewed publications or recognised clinical expertise in IAH/ACS; willing to complete all rounds; fluent in English.
Who cannot join
- Inability to commit to all rounds; undeclared conflict of interest relevant to a statement (managed by abstention on that statement).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: This is an International Modified Delphi Consensus on Practical Management Statements for Intra-abdominal Hypertension and Abdominal Compartment Syndrome Where Direct Evidence Is Lacking: An Abdominal Compartment Society (WSACS) Initiative. It Involves the Anonymous Completion of a Questionnaire Using a 7-point Likert Scale.
The Abdominal Compartment Society (WSACS) is updating its 2013 clinical practice guidelines on intra-abdominal hypertension (IAH) and the abdominal compartment syndrome (ACS). Systematic reviews informed the evidence-based recommendations and guidelines, but many practical bedside questions lack direct evidence. This international modified Delphi will seek expert agreement on those statements, reported separately from and clearly distinguished from graded recommendations.
Read the detailed description
This study forms part of the WSACS guideline and recommendations update on intra-abdominal hypertension (IAH) and abdominal compartment syndrome (ACS).
Candidate statements are derived from the guideline development framework and from gaps identified through the accompanying evidence reviews. Before round 1 of the Delphi, the steering committee categorises statements as potential good practice statements meeting the GRADE Working Group criteria, expert consensus statements, or research priorities.
Good practice statements are considered separately by the guideline panel. Only the candidate expert consensus statements and research priorities are submitted to an international multidisciplinary Delphi panel.
Panelists rate each statement anonymously online as approve, modify, reject or abstain, and may comment. A statement accepted by more than 75% of panelists reaches consensus as worded. One accepted by fewer than 50% is rejected. One accepted by 50% to 75% is revised from the comments and re-rated in the next round, for up to three rounds. Panelists see the aggregate result of each round before the next.
Up to three rounds are planned. Anonymised aggregate feedback is provided to participants between rounds. The study evaluates agreement among experts rather than clinical effectiveness, diagnostic accuracy, or patient outcomes.
The final report will distinguish consensus from evidence-based recommendations and will follow the ACCORD reporting guideline for consensus methods.
- Being tested
- Delphi structured interview via online survey
- Keywords
- Delphi, consensus, intra-abdominal pressure, critical care, good practice statement, expert, clinical practice guideline, research priorities
- Medical subject headings
- Intra-Abdominal Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delphi structured interview via online surveyOther
An international multidisciplinary panel of clinicians and researchers with recognised expertise in intra-abdominal hypertension, abdominal compartment syndrome, intensive care, surgery, anaesthesiology, or related disciplines. Participants will complete up to three rounds of a structured online modified Delphi consensus process.
| Study group | Role | What they receive |
|---|---|---|
| Panelists | Not described Receives: Other: Delphi structured interview via online survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of candidate statements reaching consensus
Proportion of candidate statements reaching consensus, defined as more than 75% agreement.
Measured: through completion of the final round, about 12 weeks.
Secondary outcomes (4)
Number of rounds to consensus per statement
statements rejected (less than 50% agreement); stability of ratings between the final two rounds.
Measured: about 12 weeks
Proportion of statements rejected
Percentage of candidate statements rejected according to the predefined less-than-50% approval criterion
Measured: about 12 weeks
Stability of expert ratings
Changes in approval proportions between the final two rounds for statements assessed in both rounds
Measured: about 12 weeks
Proportion of unresolved statements
Percentage of statements not meeting acceptance or rejection criteria by the final round
Measured: about 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start15 Nov 2026 (estimated)
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Intra-Abdominal HypertensionStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Lublin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manu Malbrain, Medical University of Lublin
- Investigators
- Prashant Nasa, MD, Study chair, Wolverhampton HospitalManu L Malbrain, MD, PhD, Principal investigator, Medical University of Lublin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07915362
- Sponsor's protocol ID
- MUL2026WSACS002
- Other IDs
- PROSPERO
- Acronym
- WSACS-DELPHI-2
- Status last verified
- Oct 2026
- First submitted
- 29 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual responses shared for privacy; aggregate round results published in the supplement.
Publications
Nasa P, Wise RD, Smit M, Acosta S, D'Amours S, Beaubien-Souligny W, Bodnar Z, Coccolini F, Dangayach NS, Dabrowski W, Duchesne J, Ejike JC, Augustin G, De Keulenaer B, Kirkpatrick AW, Khanna AK, Kimball E, Koratala A, Lee RK, Leppaniemi A, Lerma EV, Marmolejo V, Meraz-Munoz A, Myatra SN, Niven D, Olvera C, Ordonez C, Petro C, Pereira BM, Ronco C, Regli A, Roberts DJ, Rola P, Rosen M, Shrestha GS, Sugrue M, Velez JCQ, Wald R, De Waele J, Reintam Blaser A, Malbrain MLNG. International cross-sectional survey on current and updated definitions of intra-abdominal hypertension and abdominal compartment syndrome. World J Emerg Surg. 2024 Nov 29;19(1):39. doi: 10.1186/s13017-024-00564-5.
PubMed 39609850Kirkpatrick AW, Roberts DJ, De Waele J, Jaeschke R, Malbrain ML, De Keulenaer B, Duchesne J, Bjorck M, Leppaniemi A, Ejike JC, Sugrue M, Cheatham M, Ivatury R, Ball CG, Reintam Blaser A, Regli A, Balogh ZJ, D'Amours S, Debergh D, Kaplan M, Kimball E, Olvera C; Pediatric Guidelines Sub-Committee for the World Society of the Abdominal Compartment Syndrome. 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 Jul;39(7):1190-206. doi: 10.1007/s00134-013-2906-z. Epub 2013 May 15.
PubMed 23673399Nasa 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.
PubMed 34322364
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- This is an International Modified Delphi Consensus on Practical Management Statements for Intra-abdominal Hypertension and Abdominal Compartment Syndrome Where Direct Evidence Is Lacking: An Abdominal Compartment Society (WSACS) Initiative. It Involves the Anonymous Completion of a Questionnaire Using a 7-point Likert Scale.
- ClinicalTrials.gov ID
- NCT07915362
- Acronym / sponsor ID
- WSACS-DELPHI-2 / MUL2026WSACS002
- Keywords
- Delphi, consensus, intra-abdominal pressure, critical care, good practice statement, expert, clinical practice guideline, research priorities
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Medical University of LublinUniversity, hospital or other
- Study start
- 15 Nov 2026 (estimated)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 4 Nov 2026 (actual)
- 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.
The Abdominal Compartment Society (WSACS) is updating its 2013 clinical practice guidelines on intra-abdominal hypertension (IAH) and the abdominal compartment syndrome (ACS). Systematic reviews informed the evidence-based recommendations and guidelines, but many practical bedside questions lack direct evidence. This international modified Delphi will seek expert agreement on those statements, reported separately from and clearly distinguished from graded recommendations.
Detailed description
This study forms part of the WSACS guideline and recommendations update on intra-abdominal hypertension (IAH) and abdominal compartment syndrome (ACS).
Candidate statements are derived from the guideline development framework and from gaps identified through the accompanying evidence reviews. Before round 1 of the Delphi, the steering committee categorises statements as potential good practice statements meeting the GRADE Working Group criteria, expert consensus statements, or research priorities.
Good practice statements are considered separately by the guideline panel. Only the candidate expert consensus statements and research priorities are submitted to an international multidisciplinary Delphi panel.
Panelists rate each statement anonymously online as approve, modify, reject or abstain, and may comment. A statement accepted by more than 75% of panelists reaches consensus as worded. One accepted by fewer than 50% is rejected. One accepted by 50% to 75% is revised from the comments and re-rated in the next round, for up to three rounds. Panelists see the aggregate result of each round before the next.
Up to three rounds are planned. Anonymised aggregate feedback is provided to participants between rounds. The study evaluates agreement among experts rather than clinical effectiveness, diagnostic accuracy, or patient outcomes.
The final report will distinguish consensus from evidence-based recommendations and will follow the ACCORD reporting guideline for consensus methods.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Panelists | – | Other: Delphi structured interview via online survey |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- International multidisciplinary clinical and research experts with experience relevant to IAH/ACS: We accept All adults / accepts healthy volunteers (expert panelists, not patients)
Key inclusion criteria (1 listed)
- Clinicians or researchers in intensive care, emergency or trauma surgery, anaesthesia, paediatric critical care or nursing, with peer-reviewed publications or recognised clinical expertise in IAH/ACS; willing to complete all rounds; fluent in English.
Key exclusion criteria (1 listed)
- Inability to commit to all rounds; undeclared conflict of interest relevant to a statement (managed by abstention on that statement).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Delphi structured interview via online surveyAn international multidisciplinary panel of clinicians and researchers with recognised expertise in intra-abdominal hypertension, abdominal compartment syndrome, intensive care, surgery, anaesthesiology, or related disciplines. Participants will complete up to three rounds of a structured online modified Delphi consensus process. | Other | Panelists |
Primary outcome
Proportion of candidate statements reaching consensus
Time frame: through completion of the final round, about 12 weeks.
Proportion of candidate statements reaching consensus, defined as more than 75% agreement.
4 secondary outcomes
Number of rounds to consensus per statement
Time frame: about 12 weeks
Proportion of statements rejected
Time frame: about 12 weeks
Stability of expert ratings
Time frame: about 12 weeks
Proportion of unresolved statements
Time frame: about 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Background: PubMed 39609850Nasa P, Wise RD, Smit M, Acosta S, D'Amours S, Beaubien-Souligny W, Bodnar Z, Coccolini F, Dangayach NS, Dabrowski W, Duchesne J, Ejike JC, Augustin G, De Keulenaer B, Kirkpatrick AW, Khanna AK, Kimball E, Koratala A, Lee RK, Leppaniemi A, Lerma EV, Marmolejo V, Meraz-Munoz A, Myatra SN, Niven D, Olvera C, Ordonez C, Petro C, Pereira BM, Ronco C, Regli A, Roberts DJ, Rola P, Rosen M, Shrestha GS, Sugrue M, Velez JCQ, Wald R, De Waele J, Reintam Blaser A, Malbrain MLNG. International cross-sectional survey on current and updated definitions of intra-abdominal hypertension and abdominal compartment syndrome. World J Emerg Surg. 2024 Nov 29;19(1):39. doi: 10.1186/s13017-024-00564-5.
- Background: PubMed 23673399Kirkpatrick AW, Roberts DJ, De Waele J, Jaeschke R, Malbrain ML, De Keulenaer B, Duchesne J, Bjorck M, Leppaniemi A, Ejike JC, Sugrue M, Cheatham M, Ivatury R, Ball CG, Reintam Blaser A, Regli A, Balogh ZJ, D'Amours S, Debergh D, Kaplan M, Kimball E, Olvera C; Pediatric Guidelines Sub-Committee for the World Society of the Abdominal Compartment Syndrome. 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 Jul;39(7):1190-206. doi: 10.1007/s00134-013-2906-z. Epub 2013 May 15.
- Background: PubMed 34322364Nasa 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.
- The Abdominal Compartment websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No. No individual responses shared for privacy; aggregate round results published in the supplement.
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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.
Prashant Nasa, MD study chair
Wolverhampton Hospital
Manu L Malbrain, MD, PhD principal investigator
Medical University of Lublin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intra-Abdominal Hypertension and Abdominal Compartment Syndrome, run by Medical University of Lublin at 1 site in Poland.
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 1 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
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?
Proportion of candidate statements reaching consensus (time frame: through completion of the final round, about 12 weeks.). 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 NCT07915362, which also lists 3 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 4 Nov 2026; AzTrials last refreshed its copy on 6 Nov 2026.