Efficacy of Targeted Abdominal Perfusion Pressure in Septic Shock

Phase 4

Completed

• Conditions: Septic Shock; Septicemia; Intraabdominal Hypertension; Renal Injury
• Interventions: Drug: Vasopressor Agent; Drug: Crystalloid Solutions; Procedure: Invasive Blood Pressure Monitoring; Procedure: Intra-Abdominal Pressure Monitoring; Other: Abdominal Perfusion Pressure

• Registration Number: NCT05358912
• Lead Sponsor: Bozyaka Training and Research Hospital

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.

Study Timeline

• Study Start: 2019-12-02
• Study First Submitted: 2022-04-18
• Study First Submitted QC: 2022-05-02
• Study First Posted: 2022-05-03
• Primary Completion: 2022-09-10
• Study Completion: 2022-09-21
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-28
• Last Update Posted: 2022-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 85

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Vasopressor Agent	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.
Control	Crystalloid Solutions	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.
Control	Invasive Blood Pressure Monitoring	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.
Control	Intra-Abdominal Pressure Monitoring	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.
MAP Group	Vasopressor Agent	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.
MAP Group	Crystalloid Solutions	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.
MAP Group	Invasive Blood Pressure Monitoring	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.
MAP Group	Intra-Abdominal Pressure Monitoring	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.
APP Group	Vasopressor Agent	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.
APP Group	Crystalloid Solutions	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.
APP Group	Invasive Blood Pressure Monitoring	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.
APP Group	Intra-Abdominal Pressure Monitoring	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.
APP Group	Abdominal Perfusion Pressure	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.

Primary Outcome Measures

Name	Time	Method
Change of the Level of Acute Kidney Injury	up to 90 days	Kidney damage will be monitored according to the KDIGO (Kidney Disease Improving Global Outcomes) classification.
Mortality	at 90th day of admission	Mortality in first 90 days

Trial Locations

Locations (1)

UHS Izmir Bozyaka Education and Research Hospital; 🇹🇷 Izmir, Karabağlar, Turkey