Acute Kidney InjuryMAP-APPNCT03582046
Targeting Abdominal Perfusion Pressure in Septic Shock
A study testing Abdominal Perfusion Pressure (APP) and Mean Arterial Pressure (MAP) in people with Acute Kidney Injury and Septic Shock, run by Potrero Medical at 3 sites in United States.
Trial summary
A randomized control trial among patients with septic shock, studying the incidence, progression and recovery of AKI. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury, Septic Shock, Resuscitations
- What is being tested?
- Abdominal Perfusion Pressure (APP) and Mean Arterial Pressure (MAP)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 3 sitesUnited States
- Study dates
- 5 Feb 2019to 20 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- 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)
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Grady Memorial Hospital
Atlanta, Georgia, 30303
Central Arkansas Veterans Healthcare System
Little Rock, Arkansas, 72205
University of Arkansas Medical Center
Little Rock, Arkansas, 72205
About this study
Official title: Targeting Abdominal Perfusion Pressure in Septic Shock (The MAP APP Study)
A randomized control trial among patients with septic shock, studying the incidence, progression and recovery of AKI.
Read the 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
- Being tested
- Abdominal Perfusion Pressure (APP), Mean Arterial Pressure (MAP)
- Medical subject headings
- Acute Kidney Injury, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal Perfusion Pressure (APP)Device
Also called Intra-Abdominal Pressure (IAP)
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Abdominal Perfusion Pressure (APP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2018
- Study start5 Feb 2019
- Primary completion27 Feb 2020
- Study completion20 Jun 2020
Why it stopped: Lack of Enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Potrero Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Emory University, University of Arkansas, Central Arkansas Veterans Healthcare System
- Responsible party
- Sponsor
- Investigators
- Michael J Connor, MD, Principal investigator, Emory University School of Medicine, (404) 616-0184 michael.connor@emory.eduLuis Juncos, MD, Principal investigator, CAVHS, Little Rock, AR 72205 (501) 257-1000 luis.juncos@va.govNithin Karakala, MD, Principal investigator, University of Arkansas Medical Center, Little Rock, AR NKarakala@uams.edu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03582046
- Sponsor's protocol ID
- CRD-06-2615
- Acronym
- MAP-APP
- Status last verified
- Jan 2021
- First submitted
- 27 Jun 2018
- Last updated
- 13 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Abdominal Perfusion Pressure in Septic Shock (The MAP APP Study)
- ClinicalTrials.gov ID
- NCT03582046
- Acronym / sponsor ID
- MAP-APP / CRD-06-2615
- Conditions
- Acute Kidney Injury, Septic Shock, Resuscitations
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of Enrollment
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Potrero MedicalIndustry (pharma, biotech, devices)
- Collaborators
- Emory University, University of Arkansas, Central Arkansas Veterans Healthcare System
- Study start
- 5 Feb 2019 (actual)
- Primary completion
- 27 Feb 2020 (actual)
- Study completion
- 20 Jun 2020 (actual)
- First posted
- 10 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: Mean Arterial Pressure (MAP)Patients with elevated intra-abdominal pressure of ≥ 8 mmHg for 48 hours from sepsis diagnosis. |
| Abdominal Perfusion Pressure (APP) Group | Experimental | Device: Abdominal Perfusion Pressure (APP)Patients with elevated intra-abdominal pressure of ≥ 8 mmHg for 48 hours from sepsis diagnosis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Adult (age ≥ 18)
- Septic shock - identified as early as possible as evidenced by:
- 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)
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abdominal Perfusion Pressure (APP)Also: Intra-Abdominal Pressure (IAP)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 | Abdominal Perfusion Pressure (APP) Group |
| 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. | Device | Mean Arterial Pressure (MAP) Group |
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study was stopped early (reason given: Lack of Enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael J Connor, MD principal investigator
Emory University School of Medicine, (404) 616-0184 michael.connor@emory.edu
Luis Juncos, MD principal investigator
CAVHS, Little Rock, AR 72205 (501) 257-1000 luis.juncos@va.gov
Nithin Karakala, MD principal investigator
University of Arkansas Medical Center, Little Rock, AR NKarakala@uams.edu
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abdominal Perfusion Pressure (APP) and Mean Arterial Pressure (MAP) in people with Acute Kidney Injury and Septic Shock, run by Potrero Medical at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lack of Enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2021; AzTrials last refreshed its copy on 1 Nov 2026.