Targeting Abdominal Perfusion Pressure in Septic Shock

NCT03582046 | Terminated DMC FDA Device

• 1 other identifier: CRD-06-2615
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Acute Kidney Injury; Septic Shock; Resuscitations

Outcome Measures

Primary Outcomes (1)

• 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.

  90 days

Secondary Outcomes (1)

• 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.

  90 days

Study Arms (3)

Monitoring Group

NO INTERVENTION

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.

Mean Arterial Pressure (MAP) Group

ACTIVE COMPARATOR

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

Device: Mean Arterial Pressure (MAP)

Abdominal Perfusion Pressure (APP) Group

EXPERIMENTAL

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

Device: Abdominal Perfusion Pressure (APP)

Interventions

Abdominal Perfusion Pressure (APP) 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.

Also known as: Intra-Abdominal Pressure (IAP)

Abdominal Perfusion Pressure (APP) Group

Mean Arterial Pressure (MAP) 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.

Mean Arterial Pressure (MAP) Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult (age ≥ 18)
• Septic shock - identified as early as possible as evidenced by:
• Clinical diagnosis of sepsis defined as documented or suspected infection with the use of antibiotic administration OR
• 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.)
• Indication for a urinary bladder catheter (or one currently in place)
• Indication for an arterial line (or one currently in place at any site)
• FOR MONITORING PHASE OF STUDY (MONITORING GROUP)
• All of the above criteria for the Resuscitation and Observational Periods of the study
• Intra-abdominal pressure \< 8 mmHg
• FOR INTERVENTION PHASE OF STUDY (APP VS MAP GROUPS)
• All of the above criteria for the Resuscitation and Observational Periods of the study
• Intra-abdominal pressure ≥ 8 mmHg

You may not qualify if:

• Inability to receive a urinary bladder catheter
• Chronic suprapubic catheter in place
• Cirrhosis/end stage liver disease, including Child-Pugh class C
• 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
• 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
• Active gastrointestinal bleed likely causing/contributing to the hemodynamic instability
• Acute intra-abdominal trauma (including intraabdominal surgery within the prior 30 days)
• Acute pancreatitis with no established source of infection
• Treating physician deems aggressive care is unsuitable, or has decided to de-escalate care \[Do Not Resuscitate (DNR) patients receiving standard care are still eligible\]
• 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
• 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
• Known contraindication to bladder pressure measurement
• Known pregnancy
• Suspected or known increased intracranial pressure requiring active neurosurgical consultation
• Cardiogenic shock requiring extracorporeal support

Sponsors & Collaborators

• Potrero Medical: lead
• Emory University: collaborator
• University of Arkansas: collaborator
• Central Arkansas Veterans Healthcare System: collaborator

Study Sites (3)

Central Arkansas Veterans Healthcare System

Little Rock, Arkansas, 72205, United States

Location

University of Arkansas Medical Center

Little Rock, Arkansas, 72205, United States

Location

Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

Location

MeSH Terms

Conditions

Acute Kidney Injury; Shock, Septic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Michael J Connor, MD

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

  PRINCIPAL INVESTIGATOR

• Luis Juncos, MD

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

  PRINCIPAL INVESTIGATOR

• Nithin Karakala, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2018
• First Posted: July 10, 2018
• Study Start: February 5, 2019
• Primary Completion: February 27, 2020
• Study Completion: June 20, 2020
• Last Updated: January 13, 2021

Record last verified: 2021-01

Locations

US (3)