Does Targeted Abdominal Perfusion Pressure Reduce Renal Injury and Mortality in Septic Shock Patients? A Prospective Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- Change of the Level of Acute Kidney Injury
研究概览
简要总结
Septic shock is a clinical condition that is defined as a subset of sepsis that causes very high mortality and morbidity.
Surviving sepsis campaign guideline states that the target mean arterial pressure should be 65 mmHg and above in septic shock patients. It is known that abdominal pressure increases and perfusion of intra-abdominal organs decreases in septic shock patients.
With this study, we aim to investigate the effects of targeted abdominal perfusion pressure (60 mmHg and above) on renal injury, reversal of renal injury, liver functions and ultimately mortality in patients with septic shock.
详细描述
Patients diagnosed with septic shock according to "Surviving Sepsis Campaign Guidelines 2021" will be included in the study.
Groups will be formed after the measurement of intra-abdominal pressure (IAP). Those with IAP of less than 8 mmHg will be assigned to the control group and treated according to mean arterial pressure. Those with IAP greater than 8 mmHg will be divided into two groups by computer-generated randomization (via randomizer.org). One group (Group MAP) will be treated according to mean arterial pressure and the other group (Group APP) will be treated according to abdominal perfusion pressure. In Group APP, maximum arterial pressure will be targeted as 130/85 mmHg.
All patients will receive appropriate antibiotic therapy, fluid therapy and, vasopressor treatment as recommended in "Surviving Sepsis Campaign Guidelines 2021" and abdominal pressure measurement will be repeated every 12 hours.
Age, sex, body mass index, cause of sepsis and comorbidities of all patients will be recorded.
Patients will be followed for liver and kidney function tests, procalcitonin and lactate levels, daily SOFA (Sequential Organ Failure Assessment) calculations, length of stay (days), length of stay in mechanical ventilator (days), and 30 and 90 days mortality.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
Patients will be blind to their designated groups.
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
- •Diagnosis of septicemia according to "Surviving Sepsis Campaign Guidelines 2021"
- •Age lower than 18
排除标准
- •Reason of admission: Cardiac arrest
- •Pregnancy
- •Abdominal surgery in the past 90 days
- •Pre-diagnosis of end-stage renal disease
- •History of abdominal trauma
- •Body mass index of 30 and above
- •Trauma, bleeding or cerebrovascular event that causes increased intracranial pressure
研究组 & 干预措施
APP Group
Patients who are diagnosed with septic shock and who have intra-abdominal pressure greater than 8 mmHg.
Target abdominal perfusion pressure is 65 mmHg and above.
干预措施: Crystalloid Solutions (Drug)
Control
Patients who are diagnosed with septic shock and who have intra-abdominal pressure of less than 8 mmHg.
Target mean arterial pressure is 65 mmHg and above.
干预措施: Vasopressor Agent (Drug)
Control
Patients who are diagnosed with septic shock and who have intra-abdominal pressure of less than 8 mmHg.
Target mean arterial pressure is 65 mmHg and above.
干预措施: Crystalloid Solutions (Drug)
Control
Patients who are diagnosed with septic shock and who have intra-abdominal pressure of less than 8 mmHg.
Target mean arterial pressure is 65 mmHg and above.
干预措施: Invasive Blood Pressure Monitoring (Procedure)
Control
Patients who are diagnosed with septic shock and who have intra-abdominal pressure of less than 8 mmHg.
Target mean arterial pressure is 65 mmHg and above.
干预措施: Intra-Abdominal Pressure Monitoring (Procedure)
MAP Group
Patients who are diagnosed with septic shock and who have intra-abdominal pressure greater than 8 mmHg.
Target mean arterial pressure is 65 mmHg and above.
干预措施: Vasopressor Agent (Drug)
MAP Group
Patients who are diagnosed with septic shock and who have intra-abdominal pressure greater than 8 mmHg.
Target mean arterial pressure is 65 mmHg and above.
干预措施: Crystalloid Solutions (Drug)
MAP Group
Patients who are diagnosed with septic shock and who have intra-abdominal pressure greater than 8 mmHg.
Target mean arterial pressure is 65 mmHg and above.
干预措施: Invasive Blood Pressure Monitoring (Procedure)
MAP Group
Patients who are diagnosed with septic shock and who have intra-abdominal pressure greater than 8 mmHg.
Target mean arterial pressure is 65 mmHg and above.
干预措施: Intra-Abdominal Pressure Monitoring (Procedure)
APP Group
Patients who are diagnosed with septic shock and who have intra-abdominal pressure greater than 8 mmHg.
Target abdominal perfusion pressure is 65 mmHg and above.
干预措施: Vasopressor Agent (Drug)
APP Group
Patients who are diagnosed with septic shock and who have intra-abdominal pressure greater than 8 mmHg.
Target abdominal perfusion pressure is 65 mmHg and above.
干预措施: Invasive Blood Pressure Monitoring (Procedure)
APP Group
Patients who are diagnosed with septic shock and who have intra-abdominal pressure greater than 8 mmHg.
Target abdominal perfusion pressure is 65 mmHg and above.
干预措施: Intra-Abdominal Pressure Monitoring (Procedure)
APP Group
Patients who are diagnosed with septic shock and who have intra-abdominal pressure greater than 8 mmHg.
Target abdominal perfusion pressure is 65 mmHg and above.
干预措施: Abdominal Perfusion Pressure (Other)
结局指标
主要结局
Change of the Level of Acute Kidney Injury
时间窗: up to 90 days
Kidney damage will be monitored according to the KDIGO (Kidney Disease Improving Global Outcomes) classification.
Mortality
时间窗: at 90th day of admission
Mortality in first 90 days
次要结局
未报告次要终点
研究者
Mehmet Uğur Bilgin
MD, Anesthesiology Specialist
Bozyaka Training and Research Hospital