Intra Abdominal PressureHYPANCT06672601
Intra-abdominal Hypertension and Abdominal Compartment Syndrome in Patients After Pancreatic Procedures.
An observational study of Intra Abdominal Pressure and Abdominal Compartment Syndrome, run by Charles University, Czech Republic at 1 site in Czechia.
Trial summary
This study investigates the development of intra-abdominal hypertension and compartment syndrome in patients undergoing elective pancreatic procedures. Main objective is to determine the proportion of patients after pancreatic operation who develop elevated intra-abdominal pressure and assess its association with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intra Abdominal Pressure, Abdominal Compartment Syndrome, Pancreatic Surgery
- How many people
- 150 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Jan 2025to 31 Mar 2028
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients undergoing open or robotic pancreatic procedures in our department.
Who may be able to join
- Patients ≥ 18-year-old
- Indication for elective pancreatic procedure
- Written informed consent
Who cannot join
- Patients <18 years old.
- Contraindication for urinary catheter placement.
- Refusal to participate in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site
Department of Surgery 2nd Faculty of Medicine, Charles University and Military University Hospital Prague
Prague, Prague 6, 169 02
Štěpán-Ota Schütz, MD, 00 420 733 224 640, schutz.stepan-ota@uvn.cz
About this study
Official title: The HYPA Study: Intra-abdominal Hypertension and Abdominal Compartment Syndrome in Patients Undergoing Open and Robotic Pancreatic Procedures
This study investigates the development of intra-abdominal hypertension and compartment syndrome in patients undergoing elective pancreatic procedures. Main objective is to determine the proportion of patients after pancreatic operation who develop elevated intra-abdominal pressure and assess its association with postoperative complication rates. Another goal of the study is to compare open versus robotic pancreatic procedures regarding the occurrence of intra-abdominal hypertension and abdominal compartment syndrome.
Read the detailed description
HYPA study is designed as a prospective observational study. The primary objective of this study is to assess the risk and prevalence of intra-abdominal hypertension and abdominal compartment syndrome following pancreatic procedures. The secondary objective aims to explore potential correlations between intra-abdominal hypertension and the development of postoperative complications, such as anastomotic dehiscence, postoperative pancreatic fistulas, prolonged postoperative ileus, or delayed gastric emptying. The third objective is to compare the incidence of intra-abdominal hypertension in patients undergoing robotic versus open pancreatic procedures
- Conditions
- Intra Abdominal Pressure, Abdominal Compartment Syndrome, Pancreatic Surgery, Pancreatic Fistula After Pancreaticoduodenectomy, Delayed Gastric Emptying, Anastomotic Leaks
- Keywords
- Intra-abdominal hypertension, Compartment syndrome, Pancreatic surgery, Robotic surgery
- Medical subject headings
- Intra-Abdominal Hypertension, Gastroparesis, Anastomotic Leak, Edema, Compartment Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients after pancreatic procedures | All patients following pancreatic procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Intra-abdominal hypertension and abdominal compartment syndrome
Prevalence of intra-abdominal hypertension and abdominal compartment syndrome in patients following pancreatic procedures.
Measured: From the admission to the intensive care unit until the postoperative day 7 or until discharge from the ICU
Secondary outcomes (1)
Correlation between intra-abdominal hypertension and the development of postoperative complications.
The secondary objective aims to explore potential correlations between intra-abdominal hypertension and the development of postoperative complications, such as anastomotic dehiscence, postoperative pancreatic fistulas, prolonged postoperative ileus, or delayed gastric emptying.
Measured: From the enrollment to the 90 days follow up period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study start1 Jan 2025 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Intra Abdominal PressureStudies of the same condition, open and under way.
- More trials run by Charles University, Czech RepublicThe 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Collaborators
- Military University Hospital, Prague
- Responsible party
- Principal investigator, Štěpán-Ota Schütz, Charles University, Czech Republic
- Investigators
- Pavel Záruba, MD., Study chair, Department of Surgery 2nd Faculty of Medicine, Charles University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06672601
- Sponsor's protocol ID
- 108/19-61/2024
- Acronym
- HYPA
- Status last verified
- Nov 2024
- First submitted
- 1 Nov 2024
- Last updated
- 8 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD that underlie results in a publication
Publications
Smit M, Koopman B, Dieperink W, Hulscher JBF, Hofker HS, van Meurs M, Zijlstra JG. Intra-abdominal hypertension and abdominal compartment syndrome in patients admitted to the ICU. Ann Intensive Care. 2020 Oct 1;10(1):130. doi: 10.1186/s13613-020-00746-9.
PubMed 33001288Reintam Blaser A, Regli A, De Keulenaer B, Kimball EJ, Starkopf L, Davis WA, Greiffenstein P, Starkopf J; Incidence, Risk Factors, and Outcomes of Intra-Abdominal (IROI) Study Investigators. 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.
PubMed 30608280Mancilla Asencio C, Berger Fleiszig Z. Intra-Abdominal Hypertension: A Systemic Complication of Severe Acute Pancreatitis. Medicina (Kaunas). 2022 Jun 10;58(6):785. doi: 10.3390/medicina58060785.
PubMed 35744049Hunter JD, Damani Z. Intra-abdominal hypertension and the abdominal compartment syndrome. Anaesthesia. 2004 Sep;59(9):899-907. doi: 10.1111/j.1365-2044.2004.03712.x.
PubMed 15310355Ball CG, Kirkpatrick AW, McBeth P. The secondary abdominal compartment syndrome: not just another post-traumatic complication. Can J Surg. 2008 Oct;51(5):399-405.
PubMed 18841232Leon M, Chavez L, Surani S. Abdominal compartment syndrome among surgical patients. World J Gastrointest Surg. 2021 Apr 27;13(4):330-339. doi: 10.4240/wjgs.v13.i4.330.
PubMed 33968300Sugrue M, Jones F, Deane SA, Bishop G, Bauman A, Hillman K. Intra-abdominal hypertension is an independent cause of postoperative renal impairment. Arch Surg. 1999 Oct;134(10):1082-5. doi: 10.1001/archsurg.134.10.1082.
PubMed 10522851Sugrue M, Buist MD, Hourihan F, Deane S, Bauman A, Hillman K. Prospective study of intra-abdominal hypertension and renal function after laparotomy. Br J Surg. 1995 Feb;82(2):235-8. doi: 10.1002/bjs.1800820234.
PubMed 7749700Gray S, Christensen M, Craft J. The gastro-renal effects of intra-abdominal hypertension: Implications for critical care nurses. Intensive Crit Care Nurs. 2018 Oct;48:69-74. doi: 10.1016/j.iccn.2018.06.001. Epub 2018 Jun 21.
PubMed 29937073De Waele JJ, De Laet I, Kirkpatrick AW, Hoste E. Intra-abdominal Hypertension and Abdominal Compartment Syndrome. Am J Kidney Dis. 2011 Jan;57(1):159-69. doi: 10.1053/j.ajkd.2010.08.034.
PubMed 21184922Kirkpatrick 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 23673399Schutz SO, Zaruba P, Rara A, Sotak M, Havlikova S, Modrak M, Tyll T, Pohnan R. HYPA study: protocol for investigating intra-abdominal hypertension and abdominal compartment syndrome in patients undergoing open and robotic pancreatic procedures. BMC Surg. 2025 Nov 11;25(1):536. doi: 10.1186/s12893-025-03294-w.
PubMed 41219702
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The HYPA Study: Intra-abdominal Hypertension and Abdominal Compartment Syndrome in Patients Undergoing Open and Robotic Pancreatic Procedures
- ClinicalTrials.gov ID
- NCT06672601
- Acronym / sponsor ID
- HYPA / 108/19-61/2024
- Conditions
- Intra Abdominal Pressure, Abdominal Compartment Syndrome, Pancreatic Surgery, Pancreatic Fistula After Pancreaticoduodenectomy, Delayed Gastric Emptying, Anastomotic Leaks
- Keywords
- Intra-abdominal hypertension, Compartment syndrome, Pancreatic surgery, Robotic surgery
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Collaborators
- Military University Hospital, Prague
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 4 Nov 2024 (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.
This study investigates the development of intra-abdominal hypertension and compartment syndrome in patients undergoing elective pancreatic procedures. Main objective is to determine the proportion of patients after pancreatic operation who develop elevated intra-abdominal pressure and assess its association with postoperative complication rates. Another goal of the study is to compare open versus robotic pancreatic procedures regarding the occurrence of intra-abdominal hypertension and abdominal compartment syndrome.
Detailed description
HYPA study is designed as a prospective observational study. The primary objective of this study is to assess the risk and prevalence of intra-abdominal hypertension and abdominal compartment syndrome following pancreatic procedures. The secondary objective aims to explore potential correlations between intra-abdominal hypertension and the development of postoperative complications, such as anastomotic dehiscence, postoperative pancreatic fistulas, prolonged postoperative ileus, or delayed gastric emptying. The third objective is to compare the incidence of intra-abdominal hypertension in patients undergoing robotic versus open pancreatic procedures
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients after pancreatic procedures | – | –All patients following pancreatic procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients undergoing open or robotic pancreatic procedures in our department.
Key inclusion criteria (3 listed)
- Patients ≥ 18-year-old
- Indication for elective pancreatic procedure
- Written informed consent
Key exclusion criteria (3 listed)
- Patients <18 years old.
- Contraindication for urinary catheter placement.
- Refusal to participate in the study.
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
Prevalence of Intra-abdominal hypertension and abdominal compartment syndrome
Time frame: From the admission to the intensive care unit until the postoperative day 7 or until discharge from the ICU
Prevalence of intra-abdominal hypertension and abdominal compartment syndrome in patients following pancreatic procedures.
1 secondary outcome
Correlation between intra-abdominal hypertension and the development of postoperative complications.
Time frame: From the enrollment to the 90 days follow up period.
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 8 Nov 2024.
- Background: PubMed 33001288Smit M, Koopman B, Dieperink W, Hulscher JBF, Hofker HS, van Meurs M, Zijlstra JG. Intra-abdominal hypertension and abdominal compartment syndrome in patients admitted to the ICU. Ann Intensive Care. 2020 Oct 1;10(1):130. doi: 10.1186/s13613-020-00746-9.
- Background: PubMed 30608280Reintam Blaser A, Regli A, De Keulenaer B, Kimball EJ, Starkopf L, Davis WA, Greiffenstein P, Starkopf J; Incidence, Risk Factors, and Outcomes of Intra-Abdominal (IROI) Study Investigators. 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.
- Background: PubMed 35744049Mancilla Asencio C, Berger Fleiszig Z. Intra-Abdominal Hypertension: A Systemic Complication of Severe Acute Pancreatitis. Medicina (Kaunas). 2022 Jun 10;58(6):785. doi: 10.3390/medicina58060785.
- Background: PubMed 15310355Hunter JD, Damani Z. Intra-abdominal hypertension and the abdominal compartment syndrome. Anaesthesia. 2004 Sep;59(9):899-907. doi: 10.1111/j.1365-2044.2004.03712.x.
- Background: PubMed 18841232Ball CG, Kirkpatrick AW, McBeth P. The secondary abdominal compartment syndrome: not just another post-traumatic complication. Can J Surg. 2008 Oct;51(5):399-405.
- Background: PubMed 33968300Leon M, Chavez L, Surani S. Abdominal compartment syndrome among surgical patients. World J Gastrointest Surg. 2021 Apr 27;13(4):330-339. doi: 10.4240/wjgs.v13.i4.330.
- Background: PubMed 10522851Sugrue M, Jones F, Deane SA, Bishop G, Bauman A, Hillman K. Intra-abdominal hypertension is an independent cause of postoperative renal impairment. Arch Surg. 1999 Oct;134(10):1082-5. doi: 10.1001/archsurg.134.10.1082.
- Background: PubMed 7749700Sugrue M, Buist MD, Hourihan F, Deane S, Bauman A, Hillman K. Prospective study of intra-abdominal hypertension and renal function after laparotomy. Br J Surg. 1995 Feb;82(2):235-8. doi: 10.1002/bjs.1800820234.
- Background: PubMed 29937073Gray S, Christensen M, Craft J. The gastro-renal effects of intra-abdominal hypertension: Implications for critical care nurses. Intensive Crit Care Nurs. 2018 Oct;48:69-74. doi: 10.1016/j.iccn.2018.06.001. Epub 2018 Jun 21.
- Background: PubMed 21184922De Waele JJ, De Laet I, Kirkpatrick AW, Hoste E. Intra-abdominal Hypertension and Abdominal Compartment Syndrome. Am J Kidney Dis. 2011 Jan;57(1):159-69. doi: 10.1053/j.ajkd.2010.08.034.
- Results publication: 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.
- Derived from this study: PubMed 41219702Schutz SO, Zaruba P, Rara A, Sotak M, Havlikova S, Modrak M, Tyll T, Pohnan R. HYPA study: protocol for investigating intra-abdominal hypertension and abdominal compartment syndrome in patients undergoing open and robotic pancreatic procedures. BMC Surg. 2025 Nov 11;25(1):536. doi: 10.1186/s12893-025-03294-w.
- Individual participant dataSharing planned: Yes. All collected IPD that underlie results in a publication
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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.
Pavel Záruba, MD. study chair
Department of Surgery 2nd Faculty of Medicine, Charles University
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 Pressure and Abdominal Compartment Syndrome, run by Charles University, Czech Republic at 1 site in Czechia.
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 3 inclusion and 3 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: opening soon, as of the sponsor's last update on 8 Nov 2024. 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 Czechia. 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?
Contact Štěpán-Ota Schütz, MD. (00420 733224640, stepan.sch@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Intra-abdominal hypertension and abdominal compartment syndrome (time frame: From the admission to the intensive care unit until the postoperative day 7 or until discharge from the ICU). 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 NCT06672601, which also lists 12 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 8 Nov 2024; AzTrials last refreshed its copy on 8 Nov 2026.