Continuous Renal Replacement Therapy, Critical Illness, Intra-Abdominal Hypertension
Conditions
Keywords
Intra-Abdominal Pressure, Continuous Renal Replacement Therapy, CRRT, Intra-Abdominal Hypertension, Critical Care, Fluid Balance, Organ Perfusion
Brief 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. 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.
Interventions
PROCEDUREIntravesical 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.
Sponsors
Bursa Yuksek Ihtisas Training and Research Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Intra-abdominal Pressure During Continuous Renal Replacement Therapy | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of intra-abdominal hypertension | 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. |
| Duration of Continuous Renal Replacement Therapy | 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. |
| Intensive Care Unit Length of Stay | 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. |
| Hospital Length of Stay | From hospital admission to hospital discharge, up to 30 days | The total duration of hospitalization will be recorded from hospital admission to hospital discharge. |
| 30-Day Survival | 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. |
Countries
Turkey (Türkiye)
Contacts
CONTACTCihan Sedat Aytünür, MD
Outcome results
None listed