Targeting Abdominal Perfusion Pressure in Septic Shock

Intra-abdominal pressure (IAP) has proven to be an important physiologic parameter in
critically ill patients, and elevated IAP can lead to intra-abdominal hypertension (IAH).
Literature suggests that IAH is common in patients with septic shock and that there is an
association between the presence of IAH and acute kidney injury (AKI) in this group. Mean
arterial pressure (MAP) and IAP together help determine the abdominal perfusion pressure
(APP) of organs and tissues within the abdominal cavity. Current clinical guidelines for
septic shock encourage targeting MAP of 65-70 mmHg with the use of vasopressors after volume
resuscitation. However, it remains unclear if hemodynamic support targeting APP: (a) reduces
development of acute kidney injury (AKI), (b) decreases progression of AKI, or (c) improves
renal recovery rate compared to standard care for severe septic shock patients. A novel Foley
catheter and monitoring device, the Accuryn Monitoring System, is capable of detecting
physiologic changes in temperature, urine output (UO) and intra-abdominal pressure (IAP).
These data streams are captured continuously by a device that is minimally invasive and at a
high frequency which, in combination with MAP, allow for a simple calculation of abdominal
perfusion pressure (APP). The purpose of this study is to assess kidney function and recovery
in septic shock patients and elevated IAP when targeting treatment to maintain APP ≥ 60 mmHg
as compared to standard of care targeting MAP of 65-70 mmHg.

Inclusion Criteria:

1. Adult (age ≥ 18)

2. Septic shock* - identified as early as possible following admission into or from
referring ED (may be diagnosed with initiation of care/resuscitation in ED). As
evidenced by:

1. Clinical diagnosis of sepsis defined as documented or suspected infection with
the use of antibiotic administration OR

2. Meets qSOFA (Quick Sequential Organ Failure Assessment) Criteria per the Sepsis-3
definitions12:

i. Respiratory rate ≥ 22/min ii. Altered mentation iii. Systolic blood pressure ≤ 100
mmHg AND c. Shock dependent on vasopressor therapy following initial 12-hour
Resuscitation Period refractory to further volume expansion as assessed by clinical
treatment team; this may be supported by either: i. Lack of blood pressure response
following fluid bolus or passive leg raise ii. Hemodynamic data as available (e.g.
PPV, SVV, echo, PAOP, right-heart cath, etc.)

3. Requirement for a urinary bladder catheter (or one currently in place)

4. Requirement for an arterial line (or one currently in place at any site)

FOR MONITORING PHASE OF STUDY (MONITORING GROUP)

1. All of the above criteria for the Resuscitation and Observational Periods of the study

2. Intra-abdominal pressure < 8 mmHg

FOR INTERVENTION PHASE OF STUDY (APP VS MAP GROUPS)

1. All of the above criteria for the Resuscitation and Observational Periods of the study

2. Intra-abdominal pressure ≥ 8 mmHg * Sepsis dependent vasopressor therapy to maintain
MAP ≥ 65mmHg AND lactate > 2 mmol/L on presentation

Exclusion Criteria:

1. Inability to receive a urinary bladder catheter

2. Chronic suprapubic catheter in place

3. Cirrhosis/end stage liver disease, including Child-Pugh class C

4. Severe AKI as defined by life-threatening electrolyte, acidemia, or other indication
for imminent emergent dialysis needs within 12 hours of hospital admission

5. Evidence of chronic renal failure stage 5 (including serum creatinine values
consistent with CKD 5 or dialysis dependence) in 12-months prior to enrollment

6. Active gastrointestinal bleed likely causing/contributing to the hemodynamic
instability

7. Acute intra-abdominal trauma (including intraabdominal surgery within the prior 30
days)

8. Acute pancreatitis with no established source of infection

9. Treating physician deems aggressive care is unsuitable, or has decided to de-escalate
care

a. DNR patients receiving standard care are still eligible

10. In the opinion of the treating attending physician the patient is unsuitable for the
study for any legitimate reason including lack of equipoise, anticipated imminent
significant deterioration, anticipated imminent recovery, incarceration, pre-existing
medical or psychiatric condition that treating attending physician deems not
appropriate for study, or interfering medications

11. Known previous or concurrent enrollment in a treatment clinical trial that, in the
opinion of the investigator, might interfere with the objectives/endpoints of this
clinical trial

12. Known contraindication to bladder pressure measurement

13. Known pregnancy

14. Suspected or known increased intracranial pressure requiring active neurosurgical
consultation

15. Cardiogenic shock requiring extracorporeal support

16. Any requirement for chest compressions prior to enrollment