Intra-Abdominal HypertensionNCT07823387
Intra-Abdominal Pressure Changes During Continuous Renal Replacement Therapy in Critically Ill Patients
An observational study of Intra-Abdominal Hypertension and Critical Illness, run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This prospective observational study will evaluate changes in intra-abdominal pressure in critically ill adult patients receiving continuous renal replacement therapy in the intensive care unit. Intra-abdominal pressure will be measured through the urinary bladder at predefined time points during therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intra-Abdominal Hypertension, Critical Illness, Continuous Renal Replacement Therapy
- What is being tested?
- Intravesical Intra-abdominal Pressure Measurement
- Type of treatment
- Surgery or procedure
- How many people
- 95 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jul 2026to 31 Aug 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult critically ill patients admitted to the intensive care unit who receive continuous renal replacement therapy (CRRT) and meet the predefined eligibility criteria. Eligible patients will be enrolled consecutively and prospectively followed for intra-abdominal pressure measurements and relevant clinical outcomes.
Who may be able to join
- Age 18 years or older
- Admission to the intensive care unit
- Receiving continuous renal replacement therapy (CRRT)
- Presence of an indwelling urinary (Foley) catheter for intra-abdominal pressure measurement
Who cannot join
- Pregnancy
- Open abdominal wound or open abdomen
- Neurogenic bladder
- History of bladder surgery
- Pelvic hematoma
- Pelvic fracture
- Presence of an intra-abdominal mass or other anatomical/technical condition that may compromise the reliability of intravesical pressure measurement
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
SBÜ Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi
Bursa, Bursa, 16000
Cihan Sedat Aytünür, MD, +90 505 229 78 55, dr.csa@msn.com
About this study
Official title: Prospective Evaluation of Intra-Abdominal Pressure Changes in Critically Ill Patients Receiving Continuous Renal Replacement Therapy
This prospective observational study will evaluate changes in intra-abdominal pressure in critically ill adult patients receiving continuous renal replacement therapy in the intensive care unit. Intra-abdominal pressure will be measured through the urinary bladder at predefined time points during therapy. The study will also assess the relationship between intra-abdominal pressure changes and clinical variables, including fluid balance, hemodynamic parameters, vasopressor requirement, urine output, severity scores, duration of renal replacement therapy, intensive care unit and hospital length of stay, and 30-day survival. No additional treatment or therapeutic intervention will be administered for research purposes.
Read the detailed description
Intra-abdominal hypertension may occur in critically ill patients and can contribute to impaired organ perfusion and organ dysfunction. Patients receiving continuous renal replacement therapy may experience substantial changes in fluid status, which may be associated with changes in intra-abdominal pressure.
This is a single-center, prospective, observational cohort study conducted in critically ill adult patients receiving continuous renal replacement therapy in the intensive care unit. Patients who meet the study eligibility criteria will be enrolled consecutively. No additional therapeutic intervention will be performed as part of the study.
Intra-abdominal pressure will be measured using the intravesical technique through an indwelling urinary catheter. Measurements will be obtained at baseline before initiation of continuous renal replacement therapy and at 6, 12, 24, 48, and 72 hours after initiation.
Clinical and laboratory variables will be recorded, including demographic characteristics, comorbidities, indication and modality of continuous renal replacement therapy, Acute Physiology and Chronic Health Evaluation II (APACHE II) and Sequential Organ Failure Assessment (SOFA) scores, fluid balance, mean arterial pressure, vasopressor requirement, urine output, lactate level, respiratory parameters, and related clinical findings.
The primary objective is to characterize the temporal change in intra-abdominal pressure during continuous renal replacement therapy. Secondary analyses will evaluate associations between intra-abdominal pressure and clinical outcomes, including the presence of intra-abdominal hypertension, duration of continuous renal replacement therapy, intensive care unit length of stay, hospital length of stay, and 30-day survival.
The planned sample size is 95 participants.
- Being tested
- Intravesical Intra-abdominal Pressure Measurement
- Keywords
- Intra-Abdominal Pressure, Continuous Renal Replacement Therapy, CRRT, Intra-Abdominal Hypertension, Critical Care, Fluid Balance, Organ Perfusion
- Medical subject headings
- Intra-Abdominal Hypertension, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravesical Intra-abdominal Pressure MeasurementProcedure or surgery
Intravesical intra-abdominal pressure will be measured via the existing urinary catheter at baseline and at 6, 12, 24, 48, and 72 hours after initiation of continuous renal replacement therapy (CRRT). Measurements will be performed for study data collection only. No therapeutic intervention or modification of routine clinical management will be undertaken based solely on the study measurements.
| Study group | Role | What they receive |
|---|---|---|
| Critically Ill Patients Receiving Continuous Renal Replacement Therapy | Adult critically ill patients receiving continuous renal replacement therapy (CRRT) in the intensive care unit. Intra-abdominal pressure and relevant clinical parameters will be prospectively monitored from the initiation of CRRT through 72 hours. Patients will receive routine clinical care, and no additional therapeutic intervention will be performed as part of the study. Receives: Procedure: Intravesical Intra-abdominal Pressure Measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Intra-abdominal Pressure During Continuous Renal Replacement Therapy
Intra-abdominal pressure will be measured indirectly via the urinary bladder using the intravesical technique. Measurements will be obtained at baseline before initiation of continuous renal replacement therapy and at 6, 12, 24, 48, and 72 hours. The primary outcome is the change in intra-abdominal pressure over the 72-hour observation period.
Measured: Baseline to 72 hours after initiation of continuous renal replacement therapy
Secondary outcomes (5)
Occurrence of intra-abdominal hypertension
Intra-abdominal hypertension will be defined as sustained or repeated intra-abdominal pressure ≥12 mmHg during the 72-hour observation period. The occurrence of intra-abdominal hypertension will be assessed using serial intravesical intra-abdominal pressure measurements obtained at the predefined study time points.
Measured: Baseline to 72 hours after initiation of continuous renal replacement therapy
Duration of Continuous Renal Replacement Therapy
The total duration of continuous renal replacement therapy (CRRT) will be recorded from initiation to discontinuation during the intensive care unit stay.
Measured: From CRRT initiation to CRRT discontinuation, up to 30 days
Intensive Care Unit Length of Stay
The total length of stay in the intensive care unit (ICU) will be recorded from ICU admission to ICU discharge.
Measured: From ICU admission to ICU discharge, up to 30 days
Hospital Length of Stay
The total duration of hospitalization will be recorded from hospital admission to hospital discharge.
Measured: From hospital admission to hospital discharge, up to 30 days
30-Day Survival
Survival status will be assessed at 30 days after study enrollment. Patients will be classified as alive or deceased based on available clinical records and follow-up information.
Measured: 30 days after study enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2026
- Study start20 Jul 2026
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
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
- 95 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Cihan Sedat Aytünür, Bursa Yuksek Ihtisas Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07823387
- Sponsor's protocol ID
- 2024-TBEK 2026/07-12
- Other IDs
- 2024-TBEK 2026/07-12
- Status last verified
- Sep 2026
- First submitted
- 10 Sep 2026
- Last updated
- 16 Sep 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. Study data will be analyzed and reported in aggregate form, and no identifiable participant-level data will be made publicly available.
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Intra-Abdominal Pressure Changes in Critically Ill Patients Receiving Continuous Renal Replacement Therapy
- ClinicalTrials.gov ID
- NCT07823387
- Acronym / sponsor ID
- 2024-TBEK 2026/07-12
- Keywords
- Intra-Abdominal Pressure, Continuous Renal Replacement Therapy, CRRT, Intra-Abdominal Hypertension, Critical Care, Fluid Balance, Organ Perfusion
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 95 participants (estimated)
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research HospitalOther government
- Study start
- 20 Jul 2026 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 16 Sep 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 will evaluate changes in intra-abdominal pressure in critically ill adult patients receiving continuous renal replacement therapy in the intensive care unit. Intra-abdominal pressure will be measured through the urinary bladder at predefined time points during therapy. The study will also assess the relationship between intra-abdominal pressure changes and clinical variables, including fluid balance, hemodynamic parameters, vasopressor requirement, urine output, severity scores, duration of renal replacement therapy, intensive care unit and hospital length of stay, and 30-day survival. No additional treatment or therapeutic intervention will be administered for research purposes.
Detailed description
Intra-abdominal hypertension may occur in critically ill patients and can contribute to impaired organ perfusion and organ dysfunction. Patients receiving continuous renal replacement therapy may experience substantial changes in fluid status, which may be associated with changes in intra-abdominal pressure.
This is a single-center, prospective, observational cohort study conducted in critically ill adult patients receiving continuous renal replacement therapy in the intensive care unit. Patients who meet the study eligibility criteria will be enrolled consecutively. No additional therapeutic intervention will be performed as part of the study.
Intra-abdominal pressure will be measured using the intravesical technique through an indwelling urinary catheter. Measurements will be obtained at baseline before initiation of continuous renal replacement therapy and at 6, 12, 24, 48, and 72 hours after initiation.
Clinical and laboratory variables will be recorded, including demographic characteristics, comorbidities, indication and modality of continuous renal replacement therapy, Acute Physiology and Chronic Health Evaluation II (APACHE II) and Sequential Organ Failure Assessment (SOFA) scores, fluid balance, mean arterial pressure, vasopressor requirement, urine output, lactate level, respiratory parameters, and related clinical findings.
The primary objective is to characterize the temporal change in intra-abdominal pressure during continuous renal replacement therapy. Secondary analyses will evaluate associations between intra-abdominal pressure and clinical outcomes, including the presence of intra-abdominal hypertension, duration of continuous renal replacement therapy, intensive care unit length of stay, hospital length of stay, and 30-day survival.
The planned sample size is 95 participants.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Critically Ill Patients Receiving Continuous Renal Replacement Therapy | – | Procedure: Intravesical Intra-abdominal Pressure MeasurementAdult critically ill patients receiving continuous renal replacement therapy (CRRT) in the intensive care unit. Intra-abdominal pressure and relevant clinical parameters will be prospectively monitored from the initiation of CRRT through 72 hours. Patients will receive routine clinical care, and no additional therapeutic intervention will be performed as part of the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult critically ill patients admitted to the intensive care unit who receive continuous renal replacement therapy (CRRT) and meet the predefined eligibility criteria. Eligible patients will be enrolled consecutively and prospectively followed for intra-abdominal pressure measurements and relevant clinical outcomes.
Key inclusion criteria (4 listed)
- Age 18 years or older
- Admission to the intensive care unit
- Receiving continuous renal replacement therapy (CRRT)
- Presence of an indwelling urinary (Foley) catheter for intra-abdominal pressure measurement
Key exclusion criteria (7 listed)
- Pregnancy
- Open abdominal wound or open abdomen
- Neurogenic bladder
- History of bladder surgery
- Pelvic hematoma
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 |
|---|---|---|
| Intravesical Intra-abdominal Pressure MeasurementIntravesical intra-abdominal pressure will be measured via the existing urinary catheter at baseline and at 6, 12, 24, 48, and 72 hours after initiation of continuous renal replacement therapy (CRRT). Measurements will be performed for study data collection only. No therapeutic intervention or modification of routine clinical management will be undertaken based solely on the study measurements. | Procedure or surgery | Critically Ill Patients Receiving Continuous Renal Replacement Therapy |
Primary outcome
Change in Intra-abdominal Pressure During Continuous Renal Replacement Therapy
Time frame: Baseline to 72 hours after initiation of continuous renal replacement therapy
Intra-abdominal pressure will be measured indirectly via the urinary bladder using the intravesical technique. Measurements will be obtained at baseline before initiation of continuous renal replacement therapy and at 6, 12, 24, 48, and 72 hours. The primary outcome is the change in intra-abdominal pressure over the 72-hour observation period.
5 secondary outcomes
Occurrence of intra-abdominal hypertension
Time frame: Baseline to 72 hours after initiation of continuous renal replacement therapy
Duration of Continuous Renal Replacement Therapy
Time frame: From CRRT initiation to CRRT discontinuation, up to 30 days
Intensive Care Unit Length of Stay
Time frame: From ICU admission to ICU discharge, up to 30 days
Hospital Length of Stay
Time frame: From hospital admission to hospital discharge, up to 30 days
30-Day Survival
Time frame: 30 days after study enrollment
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 16 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared. Study data will be analyzed and reported in aggregate form, and no identifiable participant-level data will be made publicly available.
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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.
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 Critical Illness, 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 7 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: looking for participants now, as of the sponsor's last update on 16 Sep 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?
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 Cihan Sedat Aytünür, MD (+90 505 229 78 55, dr.csa@msn.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Intra-abdominal Pressure During Continuous Renal Replacement Therapy (time frame: Baseline to 72 hours after initiation of continuous renal replacement therapy). 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 16 Sep 2026.