Septic ShockPhase 4NCT05358912
Efficacy of Targeted Abdominal Perfusion Pressure in Septic Shock
A Phase 4 study testing Vasopressor Agent, Crystalloid Solutions and Invasive Blood Pressure Monitoring in people with Septic Shock and Septicemia, run by Bozyaka Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock, Septicemia, Intraabdominal Hypertension
- What is being tested?
- Vasopressor Agent, Crystalloid Solutions and Invasive Blood Pressure Monitoring
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Dec 2019to 21 Sep 2022
- Phase
- Phase 4
- 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
- Diagnosis of septicemia according to "Surviving Sepsis Campaign Guidelines 2021"
- Age lower than 18
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
UHS Izmir Bozyaka Education and Research Hospital
Izmir, Karabağlar, 35100
About this study
Official title: Does Targeted Abdominal Perfusion Pressure Reduce Renal Injury and Mortality in Septic Shock Patients? A Prospective Controlled Trial
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.
Read the 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.
- Conditions
- Septic Shock, Septicemia, Intraabdominal Hypertension, Renal Injury
- Being tested
- Vasopressor Agent, Crystalloid Solutions, Invasive Blood Pressure Monitoring, Intra-Abdominal Pressure Monitoring, Abdominal Perfusion Pressure
- Medical subject headings
- Shock, Septic, Sepsis, Intra-Abdominal Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vasopressor AgentDrug
Patients will receive vasopressor agents according to "Surviving Sepsis Campaign Guidelines 2021"
Crystalloid SolutionsDrug
Patients will receive crystalloid solutions according to "Surviving Sepsis Campaign Guidelines 2021"
Invasive Blood Pressure MonitoringProcedure or surgery
Also called Measurement for Mean Arterial Pressure
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 MonitoringProcedure or surgery
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 PressureOther
APP will be calculated with the following formula: (Mean arterial pressure) - (Intra-abdominal Pressure)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Vasopressor Agent; Drug: Crystalloid Solutions; Procedure: Invasive Blood Pressure Monitoring; Procedure: Intra-Abdominal Pressure Monitoring |
| 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. Receives: Drug: Vasopressor Agent; Drug: Crystalloid Solutions; Procedure: Invasive Blood Pressure Monitoring; Procedure: Intra-Abdominal Pressure Monitoring |
| 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. Receives: Drug: Vasopressor Agent; Drug: Crystalloid Solutions; Procedure: Invasive Blood Pressure Monitoring; Procedure: Intra-Abdominal Pressure Monitoring; Other: Abdominal Perfusion Pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the Level of Acute Kidney Injury
Kidney damage will be monitored according to the KDIGO (Kidney Disease Improving Global Outcomes) classification.
Measured: up to 90 days
Mortality
Mortality in first 30 days
Measured: at 30th day of admission
Mortality
Mortality in first 90 days
Measured: at 90th day of admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2022
- Study start2 Dec 2019
- Primary completion10 Sep 2022
- Study completion21 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Septic ShockStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients in different groups will be subjected to different monitoring protocols. All will be treated according to designated target values.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bozyaka Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Uğur Bilgin, Bozyaka Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05358912
- Sponsor's protocol ID
- AbdominalPressure
- Status last verified
- Nov 2022
- First submitted
- 18 Apr 2022
- Last updated
- 29 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34599691Leone 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.
PubMed 25888071Silva 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.
PubMed 22047945Ozkarakas 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.
PubMed 37721127
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Targeted Abdominal Perfusion Pressure Reduce Renal Injury and Mortality in Septic Shock Patients? A Prospective Controlled Trial
- ClinicalTrials.gov ID
- NCT05358912
- Acronym / sponsor ID
- AbdominalPressure
- Conditions
- Septic Shock, Septicemia, Intraabdominal Hypertension, Renal Injury
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Bozyaka Training and Research HospitalUniversity, hospital or other
- Study start
- 2 Dec 2019 (actual)
- Primary completion
- 10 Sep 2022 (actual)
- Study completion
- 21 Sep 2022 (actual)
- First posted
- 3 May 2022 (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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Patients in different groups will be subjected to different monitoring protocols. All will be treated according to designated target values.
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Drug: Vasopressor Agent, Drug: Crystalloid Solutions, Procedure: Invasive Blood Pressure Monitoring, Procedure: Intra-Abdominal Pressure MonitoringPatients 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 | Drug: Vasopressor Agent, Drug: Crystalloid Solutions, Procedure: Invasive Blood Pressure Monitoring, Procedure: Intra-Abdominal Pressure MonitoringPatients 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 | Drug: Vasopressor Agent, Drug: Crystalloid Solutions, Procedure: Invasive Blood Pressure Monitoring, Procedure: Intra-Abdominal Pressure Monitoring, Other: Abdominal Perfusion PressurePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of septicemia according to "Surviving Sepsis Campaign Guidelines 2021"
- Age lower than 18
Key exclusion criteria (7 listed)
- Reason of admission: Cardiac arrest
- Pregnancy
- Abdominal surgery in the past 90 days
- Pre-diagnosis of end-stage renal disease
- History of abdominal trauma
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 |
|---|---|---|
| Vasopressor AgentPatients will receive vasopressor agents according to "Surviving Sepsis Campaign Guidelines 2021" | Drug | APP Group, Control, MAP Group |
| Crystalloid SolutionsPatients will receive crystalloid solutions according to "Surviving Sepsis Campaign Guidelines 2021" | Drug | APP Group, Control, MAP Group |
| Invasive Blood Pressure MonitoringAlso: Measurement for Mean Arterial PressureInvasive 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. | Procedure or surgery | APP Group, Control, MAP Group |
| Intra-Abdominal Pressure MonitoringIAP 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. | Procedure or surgery | APP Group, Control, MAP Group |
| Abdominal Perfusion PressureAPP will be calculated with the following formula: (Mean arterial pressure) - (Intra-abdominal Pressure) | Other | APP Group |
Primary outcome
Change of the Level of Acute Kidney Injury
Time frame: up to 90 days
Kidney damage will be monitored according to the KDIGO (Kidney Disease Improving Global Outcomes) classification.
Mortality
Time frame: at 30th day of admission
Mortality in first 30 days
Mortality
Time frame: at 90th day of admission
Mortality in first 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2022.
- Background: PubMed 34599691Evans 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.
- Background: PubMed 25888071Leone 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.
- Background: PubMed 22047945Silva 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.
- Derived from this study: PubMed 37721127Ozkarakas 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.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vasopressor Agent, Crystalloid Solutions and Invasive Blood Pressure Monitoring in people with Septic Shock and Septicemia, run by Bozyaka Training and Research Hospital at 1 site in Turkey (Türkiye).
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 2 inclusion and 7 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: finished, as of the sponsor's last update on 29 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change of the Level of Acute Kidney Injury (time frame: up to 90 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05358912, which also lists 4 linked publications.
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 29 Nov 2022.