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NCT Number: NCT07823387

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

SBÜ Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi

Bursa, 16000, Turkey (Türkiye)

Location status: Recruiting

Location contact

Cihan Sedat Aytünür, MD

CONTACT

[email protected]

+90 505 229 78 55

About this study

Intra-abdominal hypertension may occur in critically ill patients and can contribute to impaired organ perfusion and organ dysfunction. Patients receiving continuous renal replacement therapy may experience substantial changes in fluid status, which may be associated with changes in intra-abdominal pressure.

This is a single-center, prospective, observational cohort study conducted in critically ill adult patients receiving continuous renal replacement therapy in the intensive care unit. Patients who meet the study eligibility criteria will be enrolled consecutively. No additional therapeutic intervention will be performed as part of the study.

Intra-abdominal pressure will be measured using the intravesical technique through an indwelling urinary catheter. Measurements will be obtained at baseline before initiation of continuous renal replacement therapy and at 6, 12, 24, 48, and 72 hours after initiation.

Clinical and laboratory variables will be recorded, including demographic characteristics, comorbidities, indication and modality of continuous renal replacement therapy, Acute Physiology and Chronic Health Evaluation II (APACHE II) and Sequential Organ Failure Assessment (SOFA) scores, fluid balance, mean arterial pressure, vasopressor requirement, urine output, lactate level, respiratory parameters, and related clinical findings.

The primary objective is to characterize the temporal change in intra-abdominal pressure during continuous renal replacement therapy. Secondary analyses will evaluate associations between intra-abdominal pressure and clinical outcomes, including the presence of intra-abdominal hypertension, duration of continuous renal replacement therapy, intensive care unit length of stay, hospital length of stay, and 30-day survival.

The planned sample size is 95 participants.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Change in Intra-abdominal Pressure During Continuous Renal Replacement Therapy

    Time frame: Baseline to 72 hours after initiation of 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.

Secondary outcomes

  1. Occurrence of intra-abdominal hypertension

    Time frame: Baseline to 72 hours after initiation of continuous renal replacement therapy

    Intra-abdominal hypertension will be defined as sustained or repeated intra-abdominal pressure ≥12 mmHg during the 72-hour observation period. The occurrence of intra-abdominal hypertension will be assessed using serial intravesical intra-abdominal pressure measurements obtained at the predefined study time points.

  2. Duration of Continuous Renal Replacement Therapy

    Time frame: From CRRT initiation to CRRT discontinuation, up to 30 days

    The total duration of continuous renal replacement therapy (CRRT) will be recorded from initiation to discontinuation during the intensive care unit stay.

  3. Intensive Care Unit Length of Stay

    Time frame: From ICU admission to ICU discharge, up to 30 days

    The total length of stay in the intensive care unit (ICU) will be recorded from ICU admission to ICU discharge.

  4. Hospital Length of Stay

    Time frame: From hospital admission to hospital discharge, up to 30 days

    The total duration of hospitalization will be recorded from hospital admission to hospital discharge.

  5. 30-Day Survival

    Time frame: 30 days after study enrollment

    Survival status will be assessed at 30 days after study enrollment. Patients will be classified as alive or deceased based on available clinical records and follow-up information.

Study contacts

Contact information is provided by the study sponsor or research team.

Cihan Sedat Aytünür, MD

CONTACT

[email protected]

+90 505 229 78 55

Sponsors and collaborators

Lead sponsor

Bursa Yuksek Ihtisas Training and Research Hospital

Other Gov

Registry information

Official study title

Prospective Evaluation of Intra-Abdominal Pressure Changes in Critically Ill Patients Receiving Continuous Renal Replacement Therapy

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 16, 2026
Registry last updated
Sep 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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