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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBursa Yuksek Ihtisas Training and Research Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Pregnancy

Open abdominal wound or open abdomen

Neurogenic bladder

History of bladder surgery

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Intravesical Intra-abdominal Pressure Measurement

    Procedure/Surgery

    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.

Treatment groups

95 Participants
are divided into 1 treatment group
Group A: Critically Ill Patients Receiving Continuous Renal Replacement Therapy1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

Occurrence of intra-abdominal hypertension

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.

Time frame
Baseline to 72 hours after initiation of continuous renal replacement therapy
2

Duration of Continuous Renal Replacement Therapy

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

Time frame
From CRRT initiation to CRRT discontinuation, up to 30 days
3

Intensive Care Unit Length of Stay

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

Time frame
From ICU admission to ICU discharge, up to 30 days
4

Hospital Length of Stay

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

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

Other outcomes

Sponsors and contacts

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