An observational study in Intra-Abdominal Hypertension, Critical Illness and Continuous Renal Replacement Therapy, sponsored by Bursa Yuksek Ihtisas Training and Research Hospital. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by Bursa Yuksek Ihtisas Training and Research Hospital · Observational
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.
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.
71 studies on the registry are indexed under Intra-Abdominal Hypertension; 16 are open to participants now.
This study's planned enrollment of 95 is close to the median of 98 across 36 observational studies indexed under Intra-Abdominal Hypertension.
Browse Intra-Abdominal Hypertension studies →Bursa Yuksek Ihtisas Training and Research Hospital is the lead sponsor of 52 studies on the registry; 22 are open to participants now.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Procedure: Intravesical Intra-abdominal Pressure Measurement
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.
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.
Time frame: Baseline to 72 hours after initiation of continuous renal replacement therapy
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 30 days after study enrollment
Plan to share: 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.
No publications or documents are linked to this record.
Started Jul 2026 (actual). Primary completion is estimated for Jul 2027, 12 months after the start.
Of 20 observational studies under Intra-Abdominal Hypertension, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 26. This study's planned 12 months is below that.
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