Intra-Abdominal HypertensionNCT07752082
The Impact of Intra-Abdominal Pressure on Mortality and Morbidity in Patients Undergoing Open-Heart Surgery
An observational study of Intra-Abdominal Hypertension and Postoperative Complications, run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This prospective observational study evaluated whether increased intra-abdominal pressure, meaning increased pressure inside the abdomen, is associated with postoperative complications and mortality in adults undergoing elective open-heart surgery with cardiopulmonary bypass. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intra-Abdominal Hypertension, Postoperative Complications
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Mar 2023to 10 Mar 2024
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
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: The study population consisted of consecutive adult patients scheduled for elective open-heart surgery with cardiopulmonary bypass at the Department of Anesthesiology and Reanimation of Bursa Yüksek İhtisas Training and Research Hospital between March 2023 and March 2024. Eligible patients who provided written informed consent were enrolled prospectively. Participants were classified according to whether intra-abdominal hypertension developed during the perioperative period. A total of 100 patients were enrolled, and 98 patients were included in the final comparative analysis.
Who may be able to join
- Age 18 years or older
- Scheduled for elective open-heart surgery using cardiopulmonary bypass
- Left ventricular ejection fraction of 40% or higher
- Provision of written informed consent
Who cannot join
- Age under 18 years
- Requirement for emergency cardiac surgery
- Open-heart surgery performed without cardiopulmonary bypass
- Body mass index of 35 kg/m² or higher
- Uncontrolled diabetes mellitus
- History of urinary bladder or urinary tract surgery
Show all 10Show fewer
- Active urinary tract infection
- Acute or chronic renal failure
- Neurogenic bladder
- History or presence of cerebrovascular disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bursa Yuksek Ihtisas Research and Education Hospital
Bursa, Yıldırım, 16310
About this study
This prospective observational study evaluated whether increased intra-abdominal pressure, meaning increased pressure inside the abdomen, is associated with postoperative complications and mortality in adults undergoing elective open-heart surgery with cardiopulmonary bypass. Intra-abdominal pressure was measured through the urinary bladder at three time points: after anesthesia induction, after closure of the sternum, and two hours after admission to the intensive care unit. Participants with an intra-abdominal pressure of 12 mmHg or higher at any measurement were compared with those whose pressure remained below 12 mmHg. The study examined postoperative recovery outcomes, including time to extubation, length of stay in the intensive care unit and hospital, postoperative complications, and mortality. It also aimed to identify perioperative factors associated with increased intra-abdominal pressure. No study-specific treatment or intervention was assigned, and all patients received standard perioperative care.
Read the detailed description
This prospective observational cohort study investigated perioperative changes in intra-abdominal pressure in patients undergoing elective open-heart surgery with cardiopulmonary bypass and examined whether increased intra-abdominal pressure was associated with postoperative recovery and adverse clinical outcomes.
Intra-abdominal pressure was assessed indirectly through urinary bladder pressure using a standardized measurement technique. Patients were placed in the supine position, 25 mL of sterile saline was instilled into the bladder, and pressure was recorded at end-expiration after zeroing the pressure transducer at the mid-axillary line. Measurements were obtained after induction of anesthesia, after sternal closure, and two hours after admission to the intensive care unit.
Intra-abdominal hypertension was defined as an intra-abdominal pressure of 12 mmHg or higher at any measurement time point. Patients meeting this definition were compared with patients whose intra-abdominal pressure remained below 12 mmHg at all measurements. Demographic, clinical, hemodynamic, laboratory, surgical, and postoperative data were collected prospectively.
No study-specific treatment or intervention was assigned. Anesthetic management, cardiopulmonary bypass management, fluid therapy, hemodynamic support, and postoperative care were provided according to routine institutional practice. The analyses were designed to evaluate associations between intra-abdominal hypertension and postoperative outcomes and to explore perioperative factors associated with increased intra-abdominal pressure. Because the study was observational, the findings were interpreted as associations rather than evidence of causality
- Keywords
- Intra-abdominal pressure, intra-abdominal hypertension, morbidity and mortality, cardiopulmonary bypass
- Medical subject headings
- Intra-Abdominal Hypertension, Postoperative Complications
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 |
|---|---|---|
| Intra-abdominal Hypertension Group | IAH (+): Patients with an intra-abdominal pressure of ≥12 mmHg at least at one measurement time point. | |
| No Intra-abdominal Hypertension Group | IAH (-): Patients with an intra-abdominal pressure of<12 mmHg at least at one measurement time point. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Postoperative Complications
The number and percentage of participants who experienced each prespecified postoperative complication were assessed separately. Complications included arrhythmia, surgical-site infection, pneumonia, acute kidney injury, neurological complications, respiratory distress requiring continuous positive airway pressure, postoperative bleeding, reintubation, and prolonged mechanical ventilation. Outcomes were compared between participants with and without intra-abdominal hypertension.
Measured: 1 year
In-Hospital All-Cause Mortality
The number and percentage of participants who died from any cause during the postoperative hospital stay were assessed and compared between participants with and without intra-abdominal hypertension.
Measured: 1 year
Secondary outcomes (2)
Time to Extubation
Postoperative time from completion of surgery to removal of the endotracheal tube, recorded in hours and compared between participants with and without intra-abdominal hypertension.
Measured: From completion of surgery to extubation
Intensive Care Unit Length of Stay
Duration of postoperative intensive care unit stay, recorded in hours and compared between participants with and without intra-abdominal hypertension.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study start2 Mar 2023
- Primary completion2 Mar 2024
- Study completion10 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ilkay Ceylan, Bursa Yuksek Ihtisas Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07752082
- Sponsor's protocol ID
- 2011-KAEK-25 2023/02-12
- Status last verified
- Mar 2023
- First submitted
- 29 Jul 2026
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because no prospective data-sharing plan or dedicated data repository was established for this study. Study findings will be reported in aggregate form in scientific publications
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Intra-Abdominal Pressure on Mortality and Morbidity in Patients Undergoing Open-Heart Surgery
- ClinicalTrials.gov ID
- NCT07752082
- Acronym / sponsor ID
- 2011-KAEK-25 2023/02-12
- Keywords
- Intra-abdominal pressure, intra-abdominal hypertension, morbidity and mortality, cardiopulmonary bypass
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research HospitalOther government
- Study start
- 2 Mar 2023 (actual)
- Primary completion
- 2 Mar 2024 (actual)
- Study completion
- 10 Mar 2024 (actual)
- First posted
- 7 Aug 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.
This prospective observational study evaluated whether increased intra-abdominal pressure, meaning increased pressure inside the abdomen, is associated with postoperative complications and mortality in adults undergoing elective open-heart surgery with cardiopulmonary bypass. Intra-abdominal pressure was measured through the urinary bladder at three time points: after anesthesia induction, after closure of the sternum, and two hours after admission to the intensive care unit. Participants with an intra-abdominal pressure of 12 mmHg or higher at any measurement were compared with those whose pressure remained below 12 mmHg. The study examined postoperative recovery outcomes, including time to extubation, length of stay in the intensive care unit and hospital, postoperative complications, and mortality. It also aimed to identify perioperative factors associated with increased intra-abdominal pressure. No study-specific treatment or intervention was assigned, and all patients received standard perioperative care.
Detailed description
This prospective observational cohort study investigated perioperative changes in intra-abdominal pressure in patients undergoing elective open-heart surgery with cardiopulmonary bypass and examined whether increased intra-abdominal pressure was associated with postoperative recovery and adverse clinical outcomes.
Intra-abdominal pressure was assessed indirectly through urinary bladder pressure using a standardized measurement technique. Patients were placed in the supine position, 25 mL of sterile saline was instilled into the bladder, and pressure was recorded at end-expiration after zeroing the pressure transducer at the mid-axillary line. Measurements were obtained after induction of anesthesia, after sternal closure, and two hours after admission to the intensive care unit.
Intra-abdominal hypertension was defined as an intra-abdominal pressure of 12 mmHg or higher at any measurement time point. Patients meeting this definition were compared with patients whose intra-abdominal pressure remained below 12 mmHg at all measurements. Demographic, clinical, hemodynamic, laboratory, surgical, and postoperative data were collected prospectively.
No study-specific treatment or intervention was assigned. Anesthetic management, cardiopulmonary bypass management, fluid therapy, hemodynamic support, and postoperative care were provided according to routine institutional practice. The analyses were designed to evaluate associations between intra-abdominal hypertension and postoperative outcomes and to explore perioperative factors associated with increased intra-abdominal pressure. Because the study was observational, the findings were interpreted as associations rather than evidence of causality
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intra-abdominal Hypertension Group | – | –IAH (+): Patients with an intra-abdominal pressure of ≥12 mmHg at least at one measurement time point. |
| No Intra-abdominal Hypertension Group | – | –IAH (-): Patients with an intra-abdominal pressure of<12 mmHg at least at one measurement time point. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consisted of consecutive adult patients scheduled for elective open-heart surgery with cardiopulmonary bypass at the Department of Anesthesiology and Reanimation of Bursa Yüksek İhtisas Training and Research Hospital between March 2023 and March 2024. Eligible patients who provided written informed consent were enrolled prospectively. Participants were classified according to whether intra-abdominal hypertension developed during the perioperative period. A total of 100 patients were enrolled, and 98 patients were included in the final comparative analysis.
Key inclusion criteria (4 listed)
- Age 18 years or older
- Scheduled for elective open-heart surgery using cardiopulmonary bypass
- Left ventricular ejection fraction of 40% or higher
- Provision of written informed consent
Key exclusion criteria (10 listed)
- Age under 18 years
- Requirement for emergency cardiac surgery
- Open-heart surgery performed without cardiopulmonary bypass
- Body mass index of 35 kg/m² or higher
- Uncontrolled diabetes mellitus
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
Number of Participants With Postoperative Complications
Time frame: 1 year
The number and percentage of participants who experienced each prespecified postoperative complication were assessed separately. Complications included arrhythmia, surgical-site infection, pneumonia, acute kidney injury, neurological complications, respiratory distress requiring continuous positive airway pressure, postoperative bleeding, reintubation, and prolonged mechanical ventilation. Outcomes were compared between participants with and without intra-abdominal hypertension.
In-Hospital All-Cause Mortality
Time frame: 1 year
The number and percentage of participants who died from any cause during the postoperative hospital stay were assessed and compared between participants with and without intra-abdominal hypertension.
2 secondary outcomes
Time to Extubation
Time frame: From completion of surgery to extubation
Intensive Care Unit Length of Stay
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because no prospective data-sharing plan or dedicated data repository was established for this study. Study findings will be reported in aggregate form in scientific publications
Related trials for Intra-Abdominal Hypertension
Enrolling by invitationObservational study
WSACS 2026 Delphi Consensus on the Practical Management of Intra-abdominal Hypertension and Abdominal Compartment Syndrome
Intra-Abdominal Hypertension, Abdominal Compartment Syndrome
Not yet recruitingObservational study
From Blast Injury to Multicompartment Dysfunction:
Compartment Syndrome, Compartment Syndrome Nontraumatic Lower Extremity
Not yet recruitingObservational study
Intra-Abdominal Pressure, Respiratory Mechanics, and Ventilator Liberation After Emergency Major Laparotomy
Intra-Abdominal Hypertension, Respiratory Mechanics
Not yet recruitingObservational study
Cumulative Intra-Abdominal Pressure Burden and Acute Kidney Injury After Emergency Abdominal Surgery
Acute Kidney Injury, Intra-Abdominal Hypertension
RecruitingObservational study
Intra-Abdominal Pressure Changes During Continuous Renal Replacement Therapy in Critically Ill Patients
Intra-Abdominal Hypertension, Critical Illness
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Postoperative Complications, run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).
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 4 inclusion and 10 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: finished, as of the sponsor's last update on 7 Aug 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of Participants With Postoperative Complications (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Aug 2026.