SBÜ Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi
Bursa, 16000, Turkey (Türkiye)
Location status: Recruiting
NCT Number: NCT07823387
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Bursa, 16000, Turkey (Türkiye)
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: Baseline to 72 hours after initiation of continuous renal replacement therapy
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: From CRRT initiation to CRRT discontinuation, up to 30 days
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 ICU admission to ICU discharge, up to 30 days
The total length of stay in the intensive care unit (ICU) will be recorded from ICU admission to ICU discharge.
Time frame: From hospital admission to hospital discharge, up to 30 days
The total duration of hospitalization will be recorded from hospital admission to hospital discharge.
Time frame: 30 days after study enrollment
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.
Contact information is provided by the study sponsor or research team.
Bursa Yuksek Ihtisas Training and Research Hospital
Other Gov
Prospective Evaluation of Intra-Abdominal Pressure Changes in Critically Ill Patients Receiving Continuous Renal Replacement Therapy
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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