Purpose

A randomized control trial among patients with septic shock, studying the incidence, progression and recovery of AKI.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Adult (age ≥ 18)
  2. Septic shock - identified as early as possible as evidenced by:
  3. Clinical diagnosis of sepsis defined as documented or suspected infection with the use of antibiotic administration OR
  4. Meets qSOFA (Quick Sequential Organ Failure Assessment) Criteria per the Sepsis-3 definitions:

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 [positive pressure ventilation], SVV [stroke volume variation], echo, PAOP [pulmonary artery occlusion pressure], right-heart catheterization, etc.)

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

4. Indication 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

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 [acute kidney injury] 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 [chronic kidney disease, stage 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 [Do Not Resuscitate (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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Care Provider)

Arm Groups

ArmDescriptionAssigned Intervention
No Intervention
Monitoring Group
Patients that sustain intra-abdominal pressure of < 8 mmHg for 48 hours from sepsis diagnosis. Patients will be monitored and given sepsis standard of care.
Active Comparator
Mean Arterial Pressure (MAP) Group
Patients with elevated intra-abdominal pressure of ≥ 8 mmHg for 48 hours from sepsis diagnosis.
  • Device: Mean Arterial Pressure (MAP)
    Intra-abdominal Pressure (IAP) recorded passively in device, but not measured or reviewed by physician. Patient will be treated with sepsis standard of care, maintaining mean arterial pressure (MAP) of ≥ 65 mmHg.
Experimental
Abdominal Perfusion Pressure (APP) Group
Patients with elevated intra-abdominal pressure of ≥ 8 mmHg for 48 hours from sepsis diagnosis.
  • Device: Abdominal Perfusion Pressure (APP)
    Intra-abdominal Pressure (IAP) actively measured and recorded every four hours, and mean arterial pressure (MAP) adjusted to maintain abdominal perfusion pressure (APP) levels ≥ 60 mmHg.
    Other names:
    • Intra-Abdominal Pressure (IAP)

Recruiting Locations

Central Arkansas Veterans Healthcare System
Little Rock, Arkansas 72205
Contact:
Brandi Mojica
501-257-5850
brandi.mojica@va.gov

University of Arkansas Medical Center
Little Rock, Arkansas 72205
Contact:
Brandi Mojica
501-257-5850
brandi.mojica@va.gov

Grady Memorial Hospital
Atlanta, Georgia 30303
Contact:
Cadeidre Washington
404-251-8986
cadeidre.washington@emory.edu

More Details

NCT ID
NCT03582046
Status
Recruiting
Sponsor
Potrero Medical

Study Contact

Ariane Marcus
888.635.7280
amarcus@potreromed.com

Detailed Description

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.