Prospective Evaluation of Intra-Abdominal Pressure Changes in Critically Ill Patients Receiving Continuous Renal Replacement Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 95
- 试验地点
- 1
- 主要终点
- Change in Intra-abdominal Pressure During Continuous Renal Replacement Therapy
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Intravesical Intra-abdominal Pressure Measurement (Procedure)
结局指标
主要结局
Change in Intra-abdominal Pressure During Continuous Renal Replacement Therapy
时间窗: 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.
次要结局
- Occurrence of intra-abdominal hypertension(Baseline to 72 hours after initiation of continuous renal replacement therapy)
- Duration of Continuous Renal Replacement Therapy(From CRRT initiation to CRRT discontinuation, up to 30 days)
- Intensive Care Unit Length of Stay(From ICU admission to ICU discharge, up to 30 days)
- Hospital Length of Stay(From hospital admission to hospital discharge, up to 30 days)
- 30-Day Survival(30 days after study enrollment)
研究者
Cihan Sedat Aytünür
Principal Investigator
Bursa Yuksek Ihtisas Training and Research Hospital