Targeting Abdominal Perfusion Pressure in Septic Shock

NCT ID: NCT03582046

Last Updated: 2021-01-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-05
• Study Completion Date: 2020-06-20

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Mean Arterial Pressure (MAP) Group

Patients with elevated intra-abdominal pressure of ≥ 8 mmHg for 48 hours from sepsis diagnosis.

Group Type: ACTIVE_COMPARATOR

Mean Arterial Pressure (MAP)

Intervention Type: DEVICE

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.

Abdominal Perfusion Pressure (APP) Group

Patients with elevated intra-abdominal pressure of ≥ 8 mmHg for 48 hours from sepsis diagnosis.

Group Type: EXPERIMENTAL

Abdominal Perfusion Pressure (APP)

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Other Intervention Names

Intra-Abdominal Pressure (IAP)

Eligibility Criteria

Inclusion Criteria

1. Adult (age ≥ 18)

2. Septic shock - identified as early as possible 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 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emory University

OTHER

Sponsor Role: collaborator

University of Arkansas

OTHER

Sponsor Role: collaborator

Central Arkansas Veterans Healthcare System

FED

Sponsor Role: collaborator

Potrero Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael J Connor, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University School of Medicine, (404) 616-0184 michael.connor@emory.edu

Luis Juncos, MD

Role: PRINCIPAL_INVESTIGATOR

CAVHS, Little Rock, AR 72205 (501) 257-1000 luis.juncos@va.gov

Nithin Karakala, MD

Role: PRINCIPAL_INVESTIGATOR

University of Arkansas Medical Center, Little Rock, AR NKarakala@uams.edu

Locations

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

Countries

United States

Other Identifiers

CRD-06-2615

Identifier Type: -

Identifier Source: org_study_id