- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03582046
Targeting Abdominal Perfusion Pressure in Septic Shock (MAP-APP)
Targeting Abdominal Perfusion Pressure in Septic Shock (The MAP APP Study)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Arkansas
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Little Rock, Arkansas, United States, 72205
- Central Arkansas Veterans Healthcare System
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Little Rock, Arkansas, United States, 72205
- University of Arkansas Medical Center
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Georgia
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Atlanta, Georgia, United States, 30303
- Grady Memorial Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: 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.
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Active Comparator: Mean Arterial Pressure (MAP) Group
Patients with elevated intra-abdominal pressure of ≥ 8 mmHg for 48 hours from sepsis diagnosis.
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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.
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Experimental: Abdominal Perfusion Pressure (APP) Group
Patients with elevated intra-abdominal pressure of ≥ 8 mmHg for 48 hours from sepsis diagnosis.
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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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Study kidney function by controlling MAP targets to maintain APP levels, in critically ill patients with septic shock and elevated IAP.
Time Frame: 90 days
|
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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
Time Frame: 90 days
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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.
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90 days
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: 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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CRD-06-2615
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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