Efficacy of Targeted Abdominal Perfusion Pressure in Septic Shock

Status Completed

Clinical 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. 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05358912
Study type	Interventional
Source	Bozyaka Training and Research Hospital
Contact
Status	Completed
Phase	Phase 4
Start date	December 2, 2019
Completion date	September 21, 2022

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT03649633` - Vitamin C, Steroids, and Thiamine, and Cerebral Autoregulation and Functional Outcome in Septic Shock	Phase 1/Phase 2
Terminated	`NCT04117568` - The Role of Emergency Neutrophils and Glycans in Postoperative and Septic Patients
Completed	`NCT04227652` - Control of Fever in Septic Patients	N/A
Completed	`NCT05629780` - Temporal Changes of Lactate in CLASSIC Patients	N/A
Recruiting	`NCT04796636` - High-dose Intravenous Vitamin C in Patients With Septic Shock	Phase 1
Terminated	`NCT03335124` - The Effect of Vitamin C, Thiamine and Hydrocortisone on Clinical Course and Outcome in Patients With Severe Sepsis and Septic Shock	Phase 4
Recruiting	`NCT04005001` - Machine Learning Sepsis Alert Notification Using Clinical Data	Phase 2
Recruiting	`NCT05217836` - Iron Metabolism Disorders in Patients With Sepsis or Septic Shock.
Recruiting	`NCT05066256` - LV Diastolic Function vs IVC Diameter Variation as Predictor of Fluid Responsiveness in Shock	N/A
Not yet recruiting	`NCT05443854` - Impact of Aminoglycosides-based Antibiotics Combination and Protective Isolation on Outcomes in Critically-ill Neutropenic Patients With Sepsis: (Combination-Lock01)	Phase 3
Not yet recruiting	`NCT04516395` - Optimizing Antibiotic Dosing Regimens for the Treatment of Infection Caused by Carbapenem Resistant Enterobacteriaceae	N/A
Recruiting	`NCT02899143` - Short-course Antimicrobial Therapy in Sepsis	Phase 2
Recruiting	`NCT02580240` - Administration of Hydrocortisone for the Treatment of Septic Shock	N/A
Recruiting	`NCT02565251` - Volemic Resuscitation in Sepsis and Septic Shock	N/A
Recruiting	`NCT02676427` - Fluid Responsiveness in Septic Shock Evaluated by Caval Ultrasound Doppler Examination
Terminated	`NCT02335723` - ASSET - a Double-Blind, Randomized Placebo-Controlled Clinical Investigation With Alteco® LPS Adsorber	N/A
Completed	`NCT02638545` - Hemodynamic Effects of Dexmedetomidine in Septic Shock	Phase 3
Not yet recruiting	`NCT02547467` - TOADS Study: TO Assess Death From Septic Shock.	N/A
Completed	`NCT02204852` - Co-administration of Iloprost and Eptifibatide in Septic Shock Patients	Phase 2
Completed	`NCT02306928` - PK Analysis of Piperacillin in Septic Shock Patients	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.