Efficacy of Targeted Abdominal Perfusion Pressure in Septic Shock

Bozyaka Training and Research Hospital

Status and phase: Completed; Phase 4

Conditions: Intraabdominal Hypertension; Septicemia; Septic Shock; Renal Injury

Treatments: Drug: Crystalloid Solutions; Drug: Vasopressor Agent; Procedure: Intra-Abdominal Pressure Monitoring; Other: Abdominal Perfusion Pressure; Procedure: Invasive Blood Pressure Monitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT05358912

AbdominalPressure

Details and patient eligibility

About

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.

Full 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.

Enrollment: 85 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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85 participants in 3 patient groups

Control

Active Comparator group

Description:

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.

Treatment:

Drug: Crystalloid Solutions

Procedure: Intra-Abdominal Pressure Monitoring

Procedure: Invasive Blood Pressure Monitoring

Drug: Vasopressor Agent

MAP Group

Active Comparator group

Description:

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.

Treatment:

Drug: Crystalloid Solutions

Procedure: Intra-Abdominal Pressure Monitoring

Procedure: Invasive Blood Pressure Monitoring

Drug: Vasopressor Agent

APP Group

Experimental group

Description:

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.

Treatment:

Drug: Crystalloid Solutions

Procedure: Intra-Abdominal Pressure Monitoring

Procedure: Invasive Blood Pressure Monitoring

Other: Abdominal Perfusion Pressure

Drug: Vasopressor Agent