Does Targeted Abdominal Perfusion Pressure Reduce Renal Injury and Mortality in Septic Shock Patients? A Prospective Controlled Trial
Overview
- Phase
- Phase 4
- Intervention
- Crystalloid Solutions
- Conditions
- Septic Shock
- Sponsor
- Bozyaka Training and Research Hospital
- Enrollment
- 85
- Locations
- 1
- Primary Endpoint
- Change of the Level of Acute Kidney Injury
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Mehmet Uğur Bilgin
MD, Anesthesiology Specialist
Bozyaka Training and Research Hospital
Eligibility Criteria
Inclusion Criteria
- •Diagnosis of septicemia according to "Surviving Sepsis Campaign Guidelines 2021"
- •Age lower than 18
Exclusion Criteria
- •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
Arms & Interventions
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.
Intervention: Crystalloid Solutions
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.
Intervention: Vasopressor Agent
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.
Intervention: Crystalloid Solutions
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.
Intervention: Invasive Blood Pressure Monitoring
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.
Intervention: Intra-Abdominal Pressure Monitoring
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.
Intervention: Vasopressor Agent
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.
Intervention: Crystalloid Solutions
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.
Intervention: Invasive Blood Pressure Monitoring
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.
Intervention: Intra-Abdominal Pressure Monitoring
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.
Intervention: Vasopressor Agent
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.
Intervention: Invasive Blood Pressure Monitoring
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.
Intervention: Intra-Abdominal Pressure Monitoring
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.
Intervention: Abdominal Perfusion Pressure
Outcomes
Primary Outcomes
Change of the Level of Acute Kidney Injury
Time Frame: up to 90 days
Kidney damage will be monitored according to the KDIGO (Kidney Disease Improving Global Outcomes) classification.
Mortality
Time Frame: at 90th day of admission
Mortality in first 90 days