Targeting Abdominal Perfusion Pressure in Septic Shock

Stopped early · Not applicable

Conditions studied: Acute Kidney Injury, Septic Shock, Resuscitations

In brief

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

Key facts

Study ID

NCT03582046

Run by

Potrero Medical

People needed

12

Starts

2019-02-05

Expected to finish

2020-06-20

Last updated by the study team

2021-01-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• Any requirement for chest compressions prior to enrollment

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.