NCT03582046

Targeting Abdominal Perfusion Pressure in Septic Shock

Targeting Abdominal Perfusion Pressure in Septic Shock (The MAP APP Study)

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Potrero Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Acute Kidney Injury
• Septic Shock
• Resuscitations

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2019-02-05
• Primary completion: 2020-02-27
• Completion: 2020-06-20
• First posted: 2018-07-10
• Last updated: 2021-01-13

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study