Efficacy of Targeted Abdominal Perfusion Pressure in Septic Shock

Study Overview
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Brief Summary
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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
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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.

Official Title
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Does Targeted Abdominal Perfusion Pressure Reduce Renal Injury and Mortality in Septic Shock Patients? A Prospective Controlled Trial

Conditions
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Septic Shock, Septicemia, Intraabdominal Hypertension, Renal Injury

Intervention / Treatment
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* Drug: Vasopressor Agent
* Drug: Crystalloid Solutions
* Procedure: Invasive Blood Pressure Monitoring
* Procedure: Intra-Abdominal Pressure Monitoring
* Other: Abdominal Perfusion Pressure


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients in different groups will be subjected to different monitoring protocols. All will be treated according to designated target values.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>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. | Drug: Vasopressor Agent<br>* Patients will receive vasopressor agents according to Surviving Sepsis Campaign Guidelines 2021<br>Drug: Crystalloid Solutions<br>* Patients will receive crystalloid solutions according to Surviving Sepsis Campaign Guidelines 2021<br>Procedure: Invasive Blood Pressure Monitoring<br>* Invasive blood pressure monitoring will be performed through an intra-arterial cannula placed in the radial artery. Philips Intellivue mx 500 monitors will be used for bedside monitoring.<br>* Other names: Measurement for Mean Arterial Pressure;Procedure: Intra-Abdominal Pressure Monitoring<br>* IAP will be measured indirectly by monitoring the pressure in the bladder. Bladder pressure will be measured through an indwelling Foley catheter every twelve hours. Twenty-five mL of sterile normal saline will be injected in each measurement and readings will be recorded with a pressure transducer.<br>|
| Active Comparator: MAP Group<br>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. | Drug: Vasopressor Agent<br>* Patients will receive vasopressor agents according to Surviving Sepsis Campaign Guidelines 2021<br>Drug: Crystalloid Solutions<br>* Patients will receive crystalloid solutions according to Surviving Sepsis Campaign Guidelines 2021<br>Procedure: Invasive Blood Pressure Monitoring<br>* Invasive blood pressure monitoring will be performed through an intra-arterial cannula placed in the radial artery. Philips Intellivue mx 500 monitors will be used for bedside monitoring.<br>* Other names: Measurement for Mean Arterial Pressure;Procedure: Intra-Abdominal Pressure Monitoring<br>* IAP will be measured indirectly by monitoring the pressure in the bladder. Bladder pressure will be measured through an indwelling Foley catheter every twelve hours. Twenty-five mL of sterile normal saline will be injected in each measurement and readings will be recorded with a pressure transducer.<br>|
| Experimental: APP Group<br>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. | Drug: Vasopressor Agent<br>* Patients will receive vasopressor agents according to Surviving Sepsis Campaign Guidelines 2021<br>Drug: Crystalloid Solutions<br>* Patients will receive crystalloid solutions according to Surviving Sepsis Campaign Guidelines 2021<br>Procedure: Invasive Blood Pressure Monitoring<br>* Invasive blood pressure monitoring will be performed through an intra-arterial cannula placed in the radial artery. Philips Intellivue mx 500 monitors will be used for bedside monitoring.<br>* Other names: Measurement for Mean Arterial Pressure;Procedure: Intra-Abdominal Pressure Monitoring<br>* IAP will be measured indirectly by monitoring the pressure in the bladder. Bladder pressure will be measured through an indwelling Foley catheter every twelve hours. Twenty-five mL of sterile normal saline will be injected in each measurement and readings will be recorded with a pressure transducer.<br>Other: Abdominal Perfusion Pressure<br>* APP will be calculated with the following formula: (Mean arterial pressure) - (Intra-abdominal Pressure)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of the Level of Acute Kidney Injury | Kidney damage will be monitored according to the KDIGO (Kidney Disease Improving Global Outcomes) classification. | up to 90 days | 
| Mortality | Mortality in first 30 days | at 30th day of admission | 
| Mortality | Mortality in first 90 days | at 90th day of admission |