NCT05358912

Efficacy of Targeted Abdominal Perfusion Pressure in Septic Shock

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 85 (actual)
• Sponsor: Bozyaka Training and Research Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Septic Shock
• Septicemia
• Intraabdominal Hypertension
• Renal Injury

Interventions

Type	Name	Description
DRUG	Vasopressor Agent	Patients will receive vasopressor agents according to "Surviving Sepsis Campaign Guidelines 2021"
DRUG	Crystalloid Solutions	Patients will receive crystalloid solutions according to "Surviving Sepsis Campaign Guidelines 2021"
PROCEDURE	Invasive Blood Pressure Monitoring	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.
PROCEDURE	Intra-Abdominal Pressure Monitoring	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.
OTHER	Abdominal Perfusion Pressure	APP will be calculated with the following formula: (Mean arterial pressure) - (Intra-abdominal Pressure)

Timeline

• Start date: 2019-12-02
• Primary completion: 2022-09-10
• Completion: 2022-09-21
• First posted: 2022-05-03
• Last updated: 2022-11-29

Locations

1 site across 1 country: Turkey (Türkiye)