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

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 85
• Phase: Phase 4

Contacts and Locations

Study Locations

• Turkey
  • Karabağlar
    • Izmir, Karabağlar, Turkey, 35100
      • UHS Izmir Bozyaka Education and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	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.; Other Names: Measurement for Mean Arterial Pressure; 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.
Active Comparator: 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.	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.; Other Names: Measurement for Mean Arterial Pressure; 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.
Experimental: 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.	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.; Other Names: Measurement for Mean Arterial Pressure; 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)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Bozyaka Training and Research Hospital

Publications and helpful links

General Publications

• Evans L, Rhodes A, Alhazzani W, Antonelli M, Coopersmith CM, French C, Machado FR, Mcintyre L, Ostermann M, Prescott HC, Schorr C, Simpson S, Wiersinga WJ, Alshamsi F, Angus DC, Arabi Y, Azevedo L, Beale R, Beilman G, Belley-Cote E, Burry L, Cecconi M, Centofanti J, Coz Yataco A, De Waele J, Dellinger RP, Doi K, Du B, Estenssoro E, Ferrer R, Gomersall C, Hodgson C, Moller MH, Iwashyna T, Jacob S, Kleinpell R, Klompas M, Koh Y, Kumar A, Kwizera A, Lobo S, Masur H, McGloughlin S, Mehta S, Mehta Y, Mer M, Nunnally M, Oczkowski S, Osborn T, Papathanassoglou E, Perner A, Puskarich M, Roberts J, Schweickert W, Seckel M, Sevransky J, Sprung CL, Welte T, Zimmerman J, Levy M. Surviving sepsis campaign: international guidelines for management of sepsis and septic shock 2021. Intensive Care Med. 2021 Nov;47(11):1181-1247. doi: 10.1007/s00134-021-06506-y. Epub 2021 Oct 2. No abstract available.
• Leone M, Asfar P, Radermacher P, Vincent JL, Martin C. Optimizing mean arterial pressure in septic shock: a critical reappraisal of the literature. Crit Care. 2015 Mar 10;19(1):101. doi: 10.1186/s13054-015-0794-z.
• Silva S, Teboul JL. Defining the adequate arterial pressure target during septic shock: not a 'micro' issue but the microcirculation can help. Crit Care. 2011;15(6):1004. doi: 10.1186/cc10486. Epub 2011 Nov 2.

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2019
• Primary Completion (Actual): September 10, 2022
• Study Completion (Actual): September 21, 2022

Study Registration Dates

• First Submitted: April 18, 2022
• First Submitted That Met QC Criteria: May 2, 2022
• First Posted (Actual): May 3, 2022

Study Record Updates

• Last Update Posted (Actual): November 29, 2022
• Last Update Submitted That Met QC Criteria: November 28, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Musculoskeletal Diseases; Muscular Diseases; Compartment Syndromes; Sepsis; Shock, Septic; Shock; Intra-Abdominal Hypertension; Vasoconstrictor Agents
• Other Study ID Numbers: AbdominalPressure

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No