Volume Removal Intolerance During Net Ultrafiltration in Acute Kidney Injury Patients

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHospital Las Higueras

About this trial

Acute kidney injury (AKI) is common in critically ill patients and is frequently associated with fluid overload, which can worsen clinical outcomes. Continuous renal replacement therapy (CRRT) allows fluid removal through net ultrafiltration (UFNET), but some patients develop hemodynamic instability or signs of poor tissue perfusion during this process.

The purpose of this prospective observational study is to evaluate tolerance to net ultrafiltration in critically ill patients with AKI receiving CRRT. The study will assess clinical, hemodynamic, ultrasound, perfusion, and biochemical parameters before and during fluid removal to identify factors associated with ultrafiltration intolerance.

The investigators hypothesize that alterations in hemodynamic, perfusion, and congestion-related parameters can identify patients at increased risk of ultrafiltration intolerance before the development of overt hypotension. The results may help improve individualized fluid removal strategies and optimize the safety of CRRT in critically ill patients.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years

Admission to an Intensive Care Unit

Acute kidney injury according to KDIGO criteria

Prescription of continuous renal replacement therapy (CRRT) with net ultrafiltration

Disqualifiers

Chronic kidney replacement therapy prior to ICU admission

Pregnancy

Limitation of therapeutic effort or goals-of-care decisions at admission or during the observation period

Inability to perform hemodynamic or perfusion assessment

Trial population

Adult critically ill patients admitted to participating intensive care units with acute kidney injury requiring continuous renal replacement therapy and prescribed net ultrafiltration as part of routine clinical care.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

128 Participants
are grouped into 1 trial group
Group A: AKI Patients Receiving CRRT With Net Ultrafiltration

Trial outcomes

Primary outcomes

1

Development of Ultrafiltration Intolerance

Proportion of patients who develop ultrafiltration intolerance according to the protocol-defined composite criteria, including hypotension, increased vasopressor requirements, worsening peripheral perfusion, tissue hypoperfusion, or reduction/interruption of ultrafiltration due to instability.

Time frame
From UFNET initiation (T0) to 24 hours after initiation of net ultrafiltration

Secondary outcomes

1

Incidence of Ultrafiltration Intolerance

Percentage of participants who develop ultrafiltration intolerance during the observation period.

Time frame
From UFNET initiation (T0) to 24 hours.
2

Net Ultrafiltration Rate (mL/kg/h)

Prescribed and achieved net ultrafiltration rate during continuous renal replacement therapy.

Time frame
From UFNET initiation (T0) to 24 hours.
3

Time to First Ultrafiltration Intolerance Event (hours)

Time from UFNET initiation to the first occurrence of ultrafiltration intolerance.

Time frame
From UFNET initiation to 24 hours.
4

Severity Category of Ultrafiltration Intolerance

Proportion of participants classified as having mild, moderate, or severe ultrafiltration intolerance according to protocol-defined criteria. Higher categories indicate greater severity of intolerance.

Time frame
From UFNET initiation to 24 hours.

Other outcomes

Sponsors and contacts

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