Acute Kidney InjuryIAP-AKINCT07891026
Cumulative Intra-Abdominal Pressure Burden and Acute Kidney Injury After Emergency Abdominal Surgery
An observational study of Acute Kidney Injury and Intra-Abdominal Hypertension, run by Ugur Duman at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury, Intra-Abdominal Hypertension
- What is being tested?
- Serial Intra-Abdominal Pressure Measurement
- How many people
- 300 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2026to 30 Nov 2027
- Phase
- Observational
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
Study population: 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.
Who may be able to join
- Age 18 years or older.
- Undergoing emergency abdominal surgery (open or laparoscopic).
- Postoperative admission to the intensive care unit.
- No evidence of acute kidney injury at postoperative ICU admission according to KDIGO criteria.
- Availability of a urinary catheter for serial intravesical intra-abdominal pressure measurements.
- Written informed consent obtained from the participant or a legally authorized representative, as applicable.
Who cannot join
- Age younger than 18 years.
- Pre-existing acute kidney injury before surgery or at postoperative ICU admission.
- End-stage kidney disease requiring maintenance dialysis.
- Conditions preventing reliable intravesical intra-abdominal pressure measurement, including major bladder injury.
- Inability to obtain informed consent from the participant or a legally authorized representative, when required.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Bursa Yuksek Ihtisas Training and Research Hospital
Bursa, 16310
Ugur Duman, MD, +905458177971, ugur.duman@sbu.edu.tr
Ugur Duman, MD
About this study
Official title: Predictive Value of Cumulative Intra-Abdominal Pressure Burden for Acute Kidney Injury in Critically Ill Patients Following Emergency Abdominal Surgery: A Prospective Observational Cohort Study
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:
- Is greater cumulative exposure to increased abdominal pressure associated with a higher risk of acute kidney injury? Participants will have abdominal pressure measured through a urinary catheter during routine intensive care. Researchers will record these measurements and information about kidney function without changing participants' treatment.
Read the detailed description
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.
- Conditions
- Acute Kidney Injury, Intra-Abdominal Hypertension
- Being tested
- Serial Intra-Abdominal Pressure Measurement
- Keywords
- Intra-Abdominal Pressure, Cumulative Intra-Abdominal Pressure Burden, Acute Kidney Injury, Abdominal Perfusion Pressure, Mean Arterial Pressure, Emergency Abdominal Surgery, Intensive Care Unit, KDIGO, Prospective Cohort Study
- Medical subject headings
- Acute Kidney Injury, Intra-Abdominal Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serial Intra-Abdominal Pressure MeasurementOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Emergency Abdominal Surgery ICU Cohort | 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. Receives: Other: Serial Intra-Abdominal Pressure Measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From surgery completion (day 0) through postoperative day 7
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From postoperative intensive care unit admission (day 0) until intensive care unit discharge or death, whichever occurs first, assessed up to 28 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2026
- Study start1 Dec 2026 (estimated)
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ugur Duman
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Ugur Duman, Bursa Yuksek Ihtisas Training and Research Hospital
- Investigators
- Ugur Duman, MD, Principal investigator, Bursa Yuksek Ihtisas Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07891026
- Sponsor's protocol ID
- 2024-TBEK 2026/09-06
- Acronym
- IAP-AKI
- Status last verified
- Oct 2026
- First submitted
- 15 Oct 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Miao S, Yang M, Li W, Yan J. Elevated IAP in critically ill patients associated with increased AKI incidence: a cohort study from the MIMIC-IV database. Sci Rep. 2025 Mar 10;15(1):8245. doi: 10.1038/s41598-024-84831-0.
PubMed 40064930Liu J, Lin SH, Zhao YS, Luo RJ, Zhang ZT, Wang LY, Xie K, Fan J, Zhang M, Chai YS, Tang H, Xu F. Incidence and risk factors of acute kidney injury after abdominal surgery: a systematic review and meta-analysis. Ann Med. 2025 Dec;57(1):2547324. doi: 10.1080/07853890.2025.2547324. Epub 2025 Aug 17.
PubMed 40819346