An observational study in Acute Kidney Injury and Intra-Abdominal Hypertension, sponsored by Ugur Duman. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Ugur Duman · Observational
The goal of this observational study is to learn whether increased pressure inside the abdomen over time is associated with acute kidney injury in adults receiving intensive care after emergency abdominal surgery. The main question it aims to answer is:
Intra-abdominal pressure varies during postoperative critical illness. Individual measurements and peak values may not fully characterize sustained or recurrent pressure elevation. Evaluating cumulative exposure may provide additional information about the relationship between abdominal pressure and postoperative renal dysfunction.
This single-center prospective observational cohort study will examine serial intra-abdominal pressure measurements obtained in a surgical intensive care unit after emergency abdominal surgery. Pressure will be measured using a standardized intravesical technique. Cumulative intra-abdominal pressure burden will be derived from repeated measurements, incorporating both the magnitude and duration of pressure elevation.
Mean arterial pressure will be recorded alongside intra-abdominal pressure to characterize the accompanying hemodynamic conditions. Abdominal perfusion pressure will be calculated as mean arterial pressure minus intra-abdominal pressure. These measurements will allow abdominal pressure exposure to be evaluated in the context of systemic pressure and abdominal perfusion.
Clinical data will include baseline renal function, illness severity, operative characteristics, fluid balance, and vasopressor use. Multivariable analyses will assess the association between cumulative pressure burden and acute kidney injury while accounting for relevant clinical factors. The predictive performance of cumulative exposure measures will also be compared with that of individual pressure measurements.
The study is observational. Clinical management will follow established practice, and treatment decisions will remain the responsibility of the attending clinicians.
1,641 studies on the registry are indexed under Acute Kidney Injury; 380 are open to participants now.
This study's planned enrollment of 300 is above the median of 156 across 795 observational studies indexed under Acute Kidney Injury.
Browse Acute Kidney Injury studies →Ugur Duman is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population will consist of adult patients aged 18 years or older admitted to the general surgery intensive care unit following emergency abdominal surgery at Bursa Yuksek Ihtisas Training and Research Hospital, Turkiye. Patients with pre-existing acute kidney injury or acute kidney injury at postoperative ICU admission will be excluded. Eligible patients will be prospectively enrolled and monitored for the development of new-onset acute kidney injury within seven days after surgery. Serial intra-abdominal pressure measurements, hemodynamic parameters, renal function indicators, and clinical outcomes will be recorded.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Adult patients admitted to the intensive care unit following emergency abdominal surgery, including open and laparoscopic procedures, will be prospectively enrolled in a single observational cohort. During the first 48 postoperative hours, intra-abdominal pressure will be measured serially using the intravesical pressure measurement technique. Mean arterial pressure will be recorded simultaneously, and abdominal perfusion pressure will be calculated as MAP minus IAP. Cumulative pressure burden parameters will be evaluated for their association with acute kidney injury occurring within the first seven postoperative days, according to KDIGO criteria. All patients will receive standard clinical care without any study-directed therapeutic intervention.
Other: Serial Intra-Abdominal Pressure Measurement
Intra-abdominal pressure will be measured serially during the first 48 postoperative hours using the intravesical pressure measurement technique through a urinary catheter. Mean arterial pressure will be recorded simultaneously, and abdominal perfusion pressure will be calculated as MAP minus IAP. Cumulative IAP, APP, and MAP burden parameters will be derived from serial measurements. These assessments will be observational and will not influence clinical treatment decisions.
Incidence of Acute Kidney Injury Within Seven Postoperative Days
The proportion of participants who develop acute kidney injury (AKI) within seven days following emergency abdominal surgery. AKI will be defined and staged according to the Kidney Disease: Improving Global Outcomes (KDIGO) criteria using changes in serum creatinine concentrations and urine output.
Time frame: From surgery completion (day 0) through postoperative day 7
Incidence of KDIGO Stage 2 or 3 Acute Kidney Injury
The proportion of participants who develop moderate to severe acute kidney injury, defined as KDIGO stage 2 or stage 3, based on serum creatinine changes and urine output criteria.
Time frame: From surgery completion (day 0) through postoperative day 7
Incidence of Oliguria
The proportion of participants who develop oliguria during postoperative monitoring. Urine output will be assessed using hourly urine output measurements and evaluated according to KDIGO urine output criteria.
Time frame: From surgery completion (day 0) through postoperative day 7
Requirement for Renal Replacement Therapy
The proportion of participants requiring renal replacement therapy during the postoperative intensive care period, including continuous or intermittent renal replacement modalities.
Time frame: From postoperative intensive care unit admission (day 0) until intensive care unit discharge or death, whichever occurs first, assessed up to 28 days
Intensive Care Unit Mortality
The proportion of participants who die from any cause during the postoperative intensive care unit stay.
Time frame: From postoperative intensive care unit admission (day 0) until intensive care unit discharge or death, whichever occurs first, assessed up to 28 days
Intensive Care Unit Length of Stay
Duration of postoperative intensive care unit stay, measured in days from intensive care unit admission until discharge or death.
Time frame: From postoperative intensive care unit admission (day 0) until intensive care unit discharge or death, whichever occurs first, assessed up to 28 days.
Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Ugur Duman