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NCT Number: NCT05358912

Efficacy of Targeted Abdominal Perfusion Pressure in Septic Shock

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.

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Key information

Conditions

Septic Shock Cardiovascular Diseases Compartment Syndromes Infections Inflammation Intra-Abdominal Hypertension Intraabdominal Hypertension Muscular Diseases Musculoskeletal Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Injury Sepsis Septicemia Shock Shock, Septic Systemic Inflammatory Response Syndrome Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

UHS Izmir Bozyaka Education and Research Hospital

Izmir, Karabağlar, 35100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vasopressor Agent

Drug

Patients will receive vasopressor agents according to "Surviving Sepsis Campaign Guidelines 2021"

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.

Other names: Measurement for Mean Arterial Pressure

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)

Primary outcomes

  1. 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.

  2. Mortality

    Time frame: at 30th day of admission

    Mortality in first 30 days

  3. Mortality

    Time frame: at 90th day of admission

    Mortality in first 90 days

Sponsors and collaborators

Lead sponsor

Bozyaka Training and Research Hospital

Other

Registry information

Official study title

Does Targeted Abdominal Perfusion Pressure Reduce Renal Injury and Mortality in Septic Shock Patients? A Prospective Controlled Trial

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
May 3, 2022
Registry last updated
Nov 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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