Efficacy of Targeted Abdominal Perfusion Pressure in Septic Shock

NCT05358912 | Completed Phase 4

• 1 other identifier: AbdominalPressure
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

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.

Conditions

Septic Shock; Septicemia; Intraabdominal Hypertension; Renal Injury

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (3)

Control

ACTIVE COMPARATOR

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; Drug: Crystalloid Solutions; Procedure: Invasive Blood Pressure Monitoring; Procedure: Intra-Abdominal Pressure Monitoring

MAP Group

ACTIVE COMPARATOR

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; Drug: Crystalloid Solutions; Procedure: Invasive Blood Pressure Monitoring; Procedure: Intra-Abdominal Pressure Monitoring

APP Group

EXPERIMENTAL

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

Interventions

Vasopressor Agent DRUG

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

APP Group; Control; MAP Group

Crystalloid Solutions DRUG

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

APP Group; Control; MAP Group

Invasive Blood Pressure Monitoring 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.

Also known as: Measurement for Mean Arterial Pressure

APP Group; Control; MAP Group

Intra-Abdominal Pressure Monitoring 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; Control; MAP Group

Abdominal Perfusion Pressure OTHER

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

APP Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of septicemia according to "Surviving Sepsis Campaign Guidelines 2021"
• Age lower than 18

You may not qualify if:

• 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

Sponsors & Collaborators

• Bozyaka Training and Research Hospital: lead

Study Sites (1)

UHS Izmir Bozyaka Education and Research Hospital

Izmir, Karabağlar, 35100, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 34599691 BACKGROUND

• 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.

  PMID: 25888071 BACKGROUND

• 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.

  PMID: 22047945 BACKGROUND

• 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.

  PMID: 37721127 DERIVED

MeSH Terms

Conditions

Shock, Septic; Sepsis; Intra-Abdominal Hypertension

Interventions

Vasoconstrictor Agents; Crystalloid Solutions; Weights and Measures; Arterial Pressure

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Compartment Syndromes; Muscular Diseases; Musculoskeletal Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiovascular Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Investigative Techniques; Blood Pressure; Hemodynamics; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients will be blind to their designated groups.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Anesthesiology Specialist

Model Details: Patients in different groups will be subjected to different monitoring protocols. All will be treated according to designated target values.

Study Record Dates

• First Submitted: April 18, 2022
• First Posted: May 3, 2022
• Study Start: December 2, 2019
• Primary Completion: September 10, 2022
• Study Completion: September 21, 2022
• Last Updated: November 29, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)