A randomized control trial among patients with septic shock, studying the incidence, progression and recovery of AKI.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
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.
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.
Central Arkansas Veterans Healthcare System
Little Rock, Arkansas, United States
University of Arkansas Medical Center
Little Rock, Arkansas, United States
Grady Memorial Hospital
Atlanta, Georgia, United States
Study kidney function by controlling MAP targets to maintain APP levels, in critically ill patients with septic shock and elevated IAP.
To study kidney function and recovery in patients with septic shock and elevated IAP as measured by timed creatinine clearance on calendar days 1-7 when targeting treatment to maintain APP ≥ 60 mmHg with a variable MAP target as compared to standard of care with a fixed MAP target. Creatinine clearance on calendar day 7 post-intervention or on day of ICU discharge, whichever is earliest, is the primary endpoint. Post hospital stay, subjects will have 30 day and 90 day follow up to check subject health status.
Time frame: 90 days
Study AKI by controlling MAP targets to maintain APP levels, in patients with IAH treated with standard of care versus patients with septic shock without IAH.
To study the incidence, progression and recovery of AKI as well as patient-centered outcomes among patients with IAH treated by APP target versus standard of care. To study renal injury and recovery and patient-centered outcomes among septic shock patients without IAH.
Time frame: 90 days
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