Cumulative Intra-Abdominal Pressure Burden and Acute Kidney Injury After Emergency Abdominal Surgery

NCT07891026 | Not Yet Recruiting

• 1 other identifier: 2024-TBEK 2026/09-06
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Acute Kidney Injury; Intra-Abdominal Hypertension

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

Outcome Measures

Primary Outcomes (1)

• 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.

  From surgery completion (day 0) through postoperative day 7

Secondary Outcomes (5)

• Incidence of KDIGO Stage 2 or 3 Acute Kidney Injury

  From surgery completion (day 0) through postoperative day 7

• Incidence of Oliguria

  From surgery completion (day 0) through postoperative day 7

• Requirement for Renal Replacement Therapy

  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

  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

  From postoperative intensive care unit admission (day 0) until intensive care unit discharge or death, whichever occurs first, assessed up to 28 days.

Study Arms (1)

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.

Other: Serial Intra-Abdominal Pressure Measurement

Interventions

Serial Intra-Abdominal Pressure Measurement OTHER

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.

Emergency Abdominal Surgery ICU Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ugur Duman: lead

Study Sites (1)

Bursa Yuksek Ihtisas Training and Research Hospital

Bursa, 16310, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 40064930 BACKGROUND

• Liu 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.

  PMID: 40819346 BACKGROUND

MeSH Terms

Conditions

Acute Kidney Injury; Intra-Abdominal Hypertension

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Compartment Syndromes; Muscular Diseases; Musculoskeletal Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Ugur Duman, MD

  Bursa Yuksek Ihtisas Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ugur Duman, MD

CONTACT

+905458177971; ugur.duman@sbu.edu.tr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of General Surgery

Study Record Dates

• First Submitted: October 15, 2026
• First Posted: October 23, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: October 23, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)