Efficacy of Targeted Abdominal Perfusion Pressure in Septic Shock
Primary Purpose
Septic Shock, Septicemia, Intraabdominal Hypertension
Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Vasopressor Agent
Crystalloid Solutions
Invasive Blood Pressure Monitoring
Intra-Abdominal Pressure Monitoring
Abdominal Perfusion Pressure
Sponsored by
About this trial
This is an interventional prevention trial for Septic Shock
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of septicemia according to "Surviving Sepsis Campaign Guidelines 2021"
- Age lower than 18
Exclusion Criteria:
- Reason of admission: Cardiac arrest
- Pregnancy
- Abdominal surgery in the past 90 days
- Pre-diagnosis of end-stage renal disease
- History of abdominal trauma
- Body mass index of 30 and above
- Trauma, bleeding or cerebrovascular event that causes increased intracranial pressure
Sites / Locations
- UHS Izmir Bozyaka Education and Research Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Experimental
Arm Label
Control
MAP Group
APP Group
Arm Description
Patients who are diagnosed with septic shock and who have intra-abdominal pressure of less than 8 mmHg. Target mean arterial pressure is 65 mmHg and above.
Patients who are diagnosed with septic shock and who have intra-abdominal pressure greater than 8 mmHg. Target mean arterial pressure is 65 mmHg and above.
Patients who are diagnosed with septic shock and who have intra-abdominal pressure greater than 8 mmHg. Target abdominal perfusion pressure is 65 mmHg and above.
Outcomes
Primary Outcome Measures
Change of the Level of Acute Kidney Injury
Kidney damage will be monitored according to the KDIGO (Kidney Disease Improving Global Outcomes) classification.
Mortality
Mortality in first 30 days
Mortality
Mortality in first 90 days
Secondary Outcome Measures
Full Information
NCT ID
NCT05358912
First Posted
April 18, 2022
Last Updated
November 28, 2022
Sponsor
Bozyaka Training and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05358912
Brief Title
Efficacy of Targeted Abdominal Perfusion Pressure in Septic Shock
Official Title
Does Targeted Abdominal Perfusion Pressure Reduce Renal Injury and Mortality in Septic Shock Patients? A Prospective Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
December 2, 2019 (Actual)
Primary Completion Date
September 10, 2022 (Actual)
Study Completion Date
September 21, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bozyaka Training and Research Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Septic shock is a clinical condition that is defined as a subset of sepsis that causes very high mortality and morbidity.
Surviving sepsis campaign guideline states that the target mean arterial pressure should be 65 mmHg and above in septic shock patients. It is known that abdominal pressure increases and perfusion of intra-abdominal organs decreases in septic shock patients.
With this study, we aim to investigate the effects of targeted abdominal perfusion pressure (60 mmHg and above) on renal injury, reversal of renal injury, liver functions and ultimately mortality in patients with septic shock.
Detailed Description
Patients diagnosed with septic shock according to "Surviving Sepsis Campaign Guidelines 2021" will be included in the study.
Groups will be formed after the measurement of intra-abdominal pressure (IAP). Those with IAP of less than 8 mmHg will be assigned to the control group and treated according to mean arterial pressure. Those with IAP greater than 8 mmHg will be divided into two groups by computer-generated randomization (via randomizer.org). One group (Group MAP) will be treated according to mean arterial pressure and the other group (Group APP) will be treated according to abdominal perfusion pressure. In Group APP, maximum arterial pressure will be targeted as 130/85 mmHg.
All patients will receive appropriate antibiotic therapy, fluid therapy and, vasopressor treatment as recommended in "Surviving Sepsis Campaign Guidelines 2021" and abdominal pressure measurement will be repeated every 12 hours.
Age, sex, body mass index, cause of sepsis and comorbidities of all patients will be recorded.
Patients will be followed for liver and kidney function tests, procalcitonin and lactate levels, daily SOFA (Sequential Organ Failure Assessment) calculations, length of stay (days), length of stay in mechanical ventilator (days), and 30 and 90 days mortality.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Septic Shock, Septicemia, Intraabdominal Hypertension, Renal Injury
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Patients in different groups will be subjected to different monitoring protocols.
All will be treated according to designated target values.
Masking
Participant
Masking Description
Patients will be blind to their designated groups.
Allocation
Randomized
Enrollment
85 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Patients who are diagnosed with septic shock and who have intra-abdominal pressure of less than 8 mmHg.
Target mean arterial pressure is 65 mmHg and above.
Arm Title
MAP Group
Arm Type
Active Comparator
Arm Description
Patients who are diagnosed with septic shock and who have intra-abdominal pressure greater than 8 mmHg.
Target mean arterial pressure is 65 mmHg and above.
Arm Title
APP Group
Arm Type
Experimental
Arm Description
Patients who are diagnosed with septic shock and who have intra-abdominal pressure greater than 8 mmHg.
Target abdominal perfusion pressure is 65 mmHg and above.
Intervention Type
Drug
Intervention Name(s)
Vasopressor Agent
Intervention Description
Patients will receive vasopressor agents according to "Surviving Sepsis Campaign Guidelines 2021"
Intervention Type
Drug
Intervention Name(s)
Crystalloid Solutions
Intervention Description
Patients will receive crystalloid solutions according to "Surviving Sepsis Campaign Guidelines 2021"
Intervention Type
Procedure
Intervention Name(s)
Invasive Blood Pressure Monitoring
Other Intervention Name(s)
Measurement for Mean Arterial Pressure
Intervention Description
Invasive blood pressure monitoring will be performed through an intra-arterial cannula placed in the radial artery. Philips Intellivue mx 500 monitors will be used for bedside monitoring.
Intervention Type
Procedure
Intervention Name(s)
Intra-Abdominal Pressure Monitoring
Intervention Description
IAP will be measured indirectly by monitoring the pressure in the bladder.
Bladder pressure will be measured through an indwelling Foley catheter every twelve hours. Twenty-five mL of sterile normal saline will be injected in each measurement and readings will be recorded with a pressure transducer.
Intervention Type
Other
Intervention Name(s)
Abdominal Perfusion Pressure
Intervention Description
APP will be calculated with the following formula: (Mean arterial pressure) - (Intra-abdominal Pressure)
Primary Outcome Measure Information:
Title
Change of the Level of Acute Kidney Injury
Description
Kidney damage will be monitored according to the KDIGO (Kidney Disease Improving Global Outcomes) classification.
Time Frame
up to 90 days
Title
Mortality
Description
Mortality in first 30 days
Time Frame
at 30th day of admission
Title
Mortality
Description
Mortality in first 90 days
Time Frame
at 90th day of admission
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of septicemia according to "Surviving Sepsis Campaign Guidelines 2021"
Age lower than 18
Exclusion Criteria:
Reason of admission: Cardiac arrest
Pregnancy
Abdominal surgery in the past 90 days
Pre-diagnosis of end-stage renal disease
History of abdominal trauma
Body mass index of 30 and above
Trauma, bleeding or cerebrovascular event that causes increased intracranial pressure
Facility Information:
Facility Name
UHS Izmir Bozyaka Education and Research Hospital
City
Izmir
State/Province
Karabağlar
ZIP/Postal Code
35100
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34599691
Citation
Evans L, Rhodes A, Alhazzani W, Antonelli M, Coopersmith CM, French C, Machado FR, Mcintyre L, Ostermann M, Prescott HC, Schorr C, Simpson S, Wiersinga WJ, Alshamsi F, Angus DC, Arabi Y, Azevedo L, Beale R, Beilman G, Belley-Cote E, Burry L, Cecconi M, Centofanti J, Coz Yataco A, De Waele J, Dellinger RP, Doi K, Du B, Estenssoro E, Ferrer R, Gomersall C, Hodgson C, Moller MH, Iwashyna T, Jacob S, Kleinpell R, Klompas M, Koh Y, Kumar A, Kwizera A, Lobo S, Masur H, McGloughlin S, Mehta S, Mehta Y, Mer M, Nunnally M, Oczkowski S, Osborn T, Papathanassoglou E, Perner A, Puskarich M, Roberts J, Schweickert W, Seckel M, Sevransky J, Sprung CL, Welte T, Zimmerman J, Levy M. Surviving sepsis campaign: international guidelines for management of sepsis and septic shock 2021. Intensive Care Med. 2021 Nov;47(11):1181-1247. doi: 10.1007/s00134-021-06506-y. Epub 2021 Oct 2. No abstract available.
Results Reference
background
PubMed Identifier
25888071
Citation
Leone M, Asfar P, Radermacher P, Vincent JL, Martin C. Optimizing mean arterial pressure in septic shock: a critical reappraisal of the literature. Crit Care. 2015 Mar 10;19(1):101. doi: 10.1186/s13054-015-0794-z.
Results Reference
background
PubMed Identifier
22047945
Citation
Silva S, Teboul JL. Defining the adequate arterial pressure target during septic shock: not a 'micro' issue but the microcirculation can help. Crit Care. 2011;15(6):1004. doi: 10.1186/cc10486. Epub 2011 Nov 2.
Results Reference
background
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Efficacy of Targeted Abdominal Perfusion Pressure in Septic Shock
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