Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | 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. |
|
| MAP Group | Active Comparator | 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. |
|
| APP Group | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vasopressor Agent | Drug | Patients will receive vasopressor agents according to "Surviving Sepsis Campaign Guidelines 2021" |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of the Level of Acute Kidney Injury | Kidney damage will be monitored according to the KDIGO (Kidney Disease Improving Global Outcomes) classification. | up to 90 days |
| Mortality | Mortality in first 30 days | at 30th day of admission |
| Mortality | Mortality in first 90 days | at 90th day of admission |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UHS Izmir Bozyaka Education and Research Hospital | Izmir | Karabağlar | 35100 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34599691 | Background | 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. | |
| 25888071 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Patients in different groups will be subjected to different monitoring protocols.
All will be treated according to designated target values.
Not provided
Not provided
Patients will be blind to their designated groups.
| Crystalloid Solutions | Drug | Patients will receive crystalloid solutions according to "Surviving Sepsis Campaign Guidelines 2021" |
|
| Invasive Blood Pressure Monitoring | Procedure | 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. |
|
|
| Intra-Abdominal Pressure Monitoring | Procedure | 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. |
|
| Abdominal Perfusion Pressure | Other | APP will be calculated with the following formula: (Mean arterial pressure) - (Intra-abdominal Pressure) |
|
| Background |
| 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. |
| 22047945 | Background | 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. |
| 37721127 | Derived | Ozkarakas H, Tekgul ZT, Arslan M, Bilgin MU, Eker HE, Okur O, Calik B. Does Maintaining a Targeted Abdominal Perfusion Pressure Reduce Renal Damage in Patients with Septic Shock?: A Randomized, Controlled, and Open-label Study. Balkan Med J. 2023 Oct 20;40(6):415-421. doi: 10.4274/balkanmedj.galenos.2023.2023-5-9. Epub 2023 Sep 18. |
| ID | Term |
|---|---|
| D012772 | Shock, Septic |
| D018805 | Sepsis |
| D059325 | Intra-Abdominal Hypertension |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
| D003161 | Compartment Syndromes |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D014662 | Vasoconstrictor Agents |
| D000077324 | Crystalloid Solutions |
| D014894 | Weights and Measures |
| D062186 | Arterial Pressure |
| ID | Term |
|---|---|
| D002317 | Cardiovascular Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D008919 | Investigative Techniques |
| D001794 | Blood Pressure |
| D006439 | Hemodynamics |
| D002320 | Cardiovascular Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
Not provided
Not provided