Intra-Abdominal Pressure Changes During Continuous Renal Replacement Therapy in Critically Ill Patients

NCT07823387 | Recruiting

• 1 other identifier: 2024-TBEK 2026/07-12
• Study Type: observational
• Target: 95
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective observational study will evaluate changes in intra-abdominal pressure in critically ill adult patients receiving continuous renal replacement therapy in the intensive care unit. Intra-abdominal pressure will be measured through the urinary bladder at predefined time points during therapy. The study will also assess the relationship between intra-abdominal pressure changes and clinical variables, including fluid balance, hemodynamic parameters, vasopressor requirement, urine output, severity scores, duration of renal replacement therapy, intensive care unit and hospital length of stay, and 30-day survival. No additional treatment or therapeutic intervention will be administered for research purposes.

Conditions

Critical Illness; Intra-Abdominal Hypertension; Continuous Renal Replacement Therapy

Keywords

Intra-Abdominal Pressure; Continuous Renal Replacement Therapy; CRRT; Intra-Abdominal Hypertension; Critical Care; Fluid Balance; Organ Perfusion

Outcome Measures

Primary Outcomes (1)

• Change in Intra-abdominal Pressure During Continuous Renal Replacement Therapy

  Intra-abdominal pressure will be measured indirectly via the urinary bladder using the intravesical technique. Measurements will be obtained at baseline before initiation of continuous renal replacement therapy and at 6, 12, 24, 48, and 72 hours. The primary outcome is the change in intra-abdominal pressure over the 72-hour observation period.

  Baseline to 72 hours after initiation of continuous renal replacement therapy

Secondary Outcomes (5)

• Occurrence of intra-abdominal hypertension

  Baseline to 72 hours after initiation of continuous renal replacement therapy

• Duration of Continuous Renal Replacement Therapy

  From CRRT initiation to CRRT discontinuation, up to 30 days

• Intensive Care Unit Length of Stay

  From ICU admission to ICU discharge, up to 30 days

• Hospital Length of Stay

  From hospital admission to hospital discharge, up to 30 days

• 30-Day Survival

  30 days after study enrollment

Study Arms (1)

Critically Ill Patients Receiving Continuous Renal Replacement Therapy

Adult critically ill patients receiving continuous renal replacement therapy (CRRT) in the intensive care unit. Intra-abdominal pressure and relevant clinical parameters will be prospectively monitored from the initiation of CRRT through 72 hours. Patients will receive routine clinical care, and no additional therapeutic intervention will be performed as part of the study.

Procedure: Intravesical Intra-abdominal Pressure Measurement

Interventions

Intravesical Intra-abdominal Pressure Measurement PROCEDURE

Intravesical intra-abdominal pressure will be measured via the existing urinary catheter at baseline and at 6, 12, 24, 48, and 72 hours after initiation of continuous renal replacement therapy (CRRT). Measurements will be performed for study data collection only. No therapeutic intervention or modification of routine clinical management will be undertaken based solely on the study measurements.

Critically Ill Patients Receiving Continuous Renal Replacement Therapy

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

Adult critically ill patients admitted to the intensive care unit who receive continuous renal replacement therapy (CRRT) and meet the predefined eligibility criteria. Eligible patients will be enrolled consecutively and prospectively followed for intra-abdominal pressure measurements and relevant clinical outcomes.

You may qualify if:

• Age 18 years or older
• Admission to the intensive care unit
• Receiving continuous renal replacement therapy (CRRT)
• Presence of an indwelling urinary (Foley) catheter for intra-abdominal pressure measurement

You may not qualify if:

• Pregnancy
• Open abdominal wound or open abdomen
• Neurogenic bladder
• History of bladder surgery
• Pelvic hematoma
• Pelvic fracture
• Presence of an intra-abdominal mass or other anatomical/technical condition that may compromise the reliability of intravesical pressure measurement

Sponsors & Collaborators

• Bursa Yuksek Ihtisas Training and Research Hospital: lead

Study Sites (1)

SBÜ Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi

Bursa, Bursa, 16000, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Intra-Abdominal Hypertension; Critical Illness

Condition Hierarchy (Ancestors)

Compartment Syndromes; Muscular Diseases; Musculoskeletal Diseases; Vascular Diseases; Cardiovascular Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Cihan Sedat Aytünür, MD

CONTACT

+90 505 229 78 55; dr.csa@msn.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 10, 2026
• First Posted: September 16, 2026
• Study Start: July 20, 2026
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: September 16, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)