Efficacy of Targeted Abdominal Perfusion Pressure in Septic Shock

NCT ID: NCT05358912

Last Updated: 2022-11-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 85 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-02
• Study Completion Date: 2022-09-21

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.

Conditions

Septic Shock; Septicemia; Intraabdominal Hypertension; Renal Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Vasopressor Agent

Intervention Type: DRUG

Patients will receive vasopressor agents according to "Surviving Sepsis Campaign Guidelines 2021"

Crystalloid Solutions

Intervention Type: DRUG

Patients will receive crystalloid solutions according to "Surviving Sepsis Campaign Guidelines 2021"

Invasive Blood Pressure Monitoring

Intervention Type: PROCEDURE

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

Intervention Type: PROCEDURE

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.

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.

Group Type: ACTIVE_COMPARATOR

Vasopressor Agent

Intervention Type: DRUG

Patients will receive vasopressor agents according to "Surviving Sepsis Campaign Guidelines 2021"

Crystalloid Solutions

Intervention Type: DRUG

Patients will receive crystalloid solutions according to "Surviving Sepsis Campaign Guidelines 2021"

Invasive Blood Pressure Monitoring

Intervention Type: PROCEDURE

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

Intervention Type: PROCEDURE

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.

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.

Group Type: EXPERIMENTAL

Vasopressor Agent

Intervention Type: DRUG

Patients will receive vasopressor agents according to "Surviving Sepsis Campaign Guidelines 2021"

Crystalloid Solutions

Intervention Type: DRUG

Patients will receive crystalloid solutions according to "Surviving Sepsis Campaign Guidelines 2021"

Invasive Blood Pressure Monitoring

Intervention Type: PROCEDURE

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

Intervention Type: PROCEDURE

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.

Abdominal Perfusion Pressure

Intervention Type: OTHER

APP will be calculated with the following formula: (Mean arterial pressure) - (Intra-abdominal Pressure)

Interventions

Vasopressor Agent

Patients will receive vasopressor agents according to "Surviving Sepsis Campaign Guidelines 2021"

Intervention Type: DRUG

Crystalloid Solutions

Patients will receive crystalloid solutions according to "Surviving Sepsis Campaign Guidelines 2021"

Intervention Type: DRUG

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Abdominal Perfusion Pressure

APP will be calculated with the following formula: (Mean arterial pressure) - (Intra-abdominal Pressure)

Intervention Type: OTHER

Other Intervention Names

Measurement for Mean Arterial Pressure

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bozyaka Training and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Mehmet Uğur Bilgin

MD, Anesthesiology Specialist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

UHS Izmir Bozyaka Education and Research Hospital

Izmir, Karabağlar, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 34599691 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25888071 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22047945 (View on PubMed)

Ozkarakas H, Tekgul ZT, Arslan M, Bilgin MU, Eker HE, Okur O, Calik B. Does Maintaining a Targeted Abdominal Perfusion Pressure Reduce Renal Damage in Patients with Septic Shock?: A Randomized, Controlled, and Open-label Study. Balkan Med J. 2023 Oct 20;40(6):415-421. doi: 10.4274/balkanmedj.galenos.2023.2023-5-9. Epub 2023 Sep 18.

Reference Type: DERIVED

PMID: 37721127 (View on PubMed)

Other Identifiers

AbdominalPressure

Identifier Type: -

Identifier Source: org_study_id