Efficacy of Targeted Abdominal Perfusion Pressure in Septic Shock

Septic Shock Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05358912
• Other study ID #: AbdominalPressure
• Status: Completed
• Phase: Phase 4
• Start date: December 2, 2019
• Est. completion date: September 21, 2022

Study information

• Verified date: November 2022
• Source: Bozyaka Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: September 21, 2022
• Est. primary completion date: September 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Intra-Abdominal Hypertension
• Intraabdominal Hypertension
• Renal Injury
• Sepsis
• Septic Shock
• Septicemia
• Shock
• Shock, Septic

Intervention

Drug:
• Vasopressor Agent
Patients will receive vasopressor agents according to "Surviving Sepsis Campaign Guidelines 2021"
• 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.
• 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)

Locations

Country	Name	City	State
Turkey	UHS Izmir Bozyaka Education and Research Hospital	Izmir	Karabaglar

Sponsors (1)

Lead Sponsor	Collaborator
Bozyaka Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Mortality	Mortality in first 30 days	at 30th day of admission
Primary	Mortality	Mortality in first 90 days	at 90th day of admission