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Volume Removal Intolerance During Net Ultrafiltration in Acute Kidney Injury Patients (VINKO)

9. Juni 2026 aktualisiert von: Gonzalo Ramirez Guerrero, Hospital Las Higueras

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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Detaillierte Beschreibung

Fluid overload is a frequent and clinically relevant complication in critically ill patients with acute kidney injury (AKI). In this setting, continuous renal replacement therapy (CRRT) is frequently used not only for solute control but also as a strategy for controlled fluid removal through net ultrafiltration (UFNET). Although UFNET is central to de-resuscitation, the individual tolerance to fluid removal is highly variable and is not fully captured by blood pressure monitoring alone.

The concept of ultrafiltration intolerance remains poorly standardized. In clinical practice, intolerance is often recognized only after overt hemodynamic instability occurs, such as hypotension, escalation of vasoactive support, or interruption of fluid removal. However, reductions in cardiac output, impaired tissue perfusion, or worsening venous congestion may precede overt hypotension. Therefore, a multiparametric assessment may allow earlier identification of patients at risk.

This is a prospective, observational, analytical study in critically ill adult patients with AKI receiving CRRT with prescribed UFNET. The study does not assign or modify therapeutic interventions. CRRT modality, anticoagulation strategy, UFNET prescription, vasopressor management, fluid administration, and all other clinical decisions will remain under the responsibility of the treating clinical team according to routine care.

The study will characterize the physiological response to UFNET using a structured multiparametric monitoring approach. Recorded domains will include conventional macrohemodynamic variables, vasoactive support, selected advanced hemodynamic variables when available, focused cardiac ultrasound, venous congestion assessment, peripheral perfusion parameters, fluid balance variables, and selected biochemical markers. Functional hemodynamic maneuvers may be performed when feasible and clinically safe.

Data will be collected prospectively using a standardized case report form. Variables will be recorded at predefined time points before and during the early phase of UFNET, with additional off-schedule recordings if clinical signs compatible with intolerance occur. Source data will be obtained from the electronic or paper medical record, bedside monitoring systems, CRRT prescription and treatment records, laboratory results, and ultrasound assessments performed as part of clinical evaluation.

A data dictionary will define each variable, including its source, units, coding, and expected physiological range when applicable. Data quality procedures will include review of completeness, range checks, consistency checks between related variables, and verification of clinically implausible values against source records. The research team will periodically review entered data to identify missing, inconsistent, or out-of-range values.

Data will be anonymized before analysis. No directly identifiable patient information will be stored in the final analytical database. Access to the study database will be restricted to authorized study investigators. Data will be stored using password-protected institutional or investigator-controlled systems according to local confidentiality and ethical requirements.

The planned sample size is 128 participants, including an estimated analytical sample of 116 participants and an approximate 10% over-recruitment to account for incomplete data, missing assessments, or inability to definitively adjudicate the outcome. The sample size was based on an analytical case-control approach aimed at identifying factors associated with ultrafiltration intolerance.

Missing data will be evaluated before statistical analysis. Variables with substantial missingness may be excluded from inferential analyses. For variables with acceptable levels of missingness, available-case analysis will be performed. The extent and pattern of missing data will be reported.

Statistical analysis will include descriptive statistics, comparison between patients who develop ultrafiltration intolerance and those who do not, and exploratory modeling to identify factors independently associated with intolerance. Continuous variables will be summarized using median and interquartile range or mean and standard deviation, as appropriate. Categorical variables will be summarized as frequencies and percentages. Group comparisons will be performed using appropriate parametric or non-parametric tests according to data distribution. Multivariable logistic regression may be used to explore independent predictors, with covariate selection based on clinical relevance and number of events.

The overall objective of this study is to improve the characterization of ultrafiltration intolerance during CRRT and to generate evidence that may support individualized, physiology-guided fluid removal strategies in critically ill patients with AKI.

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

128

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

  • Brasilien
      • Salvador, Brasilien
        • Hospital Cárdio Pulmonar
        • Kontakt:
  • Chile
      • Concepción, Chile
        • Hospital Clínico Regional de Concepción
        • Kontakt:
      • Los Ángeles, Chile
        • Complejo Asistencial Dr. Victor Ríos Ruiz
        • Kontakt:
      • Santiago, Chile
        • Hospital Clínico Dra. Eloísa Díaz Insunza de La Florida
        • Kontakt:
      • Talcahuano, Chile
        • Hospital Las Higueras de Talcahuano
        • Kontakt:
        • Kontakt:
        • Unterermittler:
          • Rodrigo Ulloa, MD
        • Unterermittler:
          • Jonathan Alarcón, MD
        • Unterermittler:
          • Ricardo Ferrada, MD
  • Ecuador
      • Quito, Ecuador
        • Hospital General Enrique Garces
        • Kontakt:
  • Italien
  • Kolumbien
      • Popayán, Kolumbien
  • Mexiko
      • Mexico City, Mexiko
  • Peru

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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.

Beschreibung

Inclusion Criteria:

  • 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
  • Clinical stability considered sufficient to initiate net ultrafiltration according to the treating clinical team

Exclusion Criteria:

  • 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
  • Extracorporeal membrane oxygenation (ECMO)
  • Refusal to participate in the study

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
AKI Patients Receiving CRRT With Net Ultrafiltration
Adult critically ill patients with acute kidney injury receiving continuous renal replacement therapy with prescribed net ultrafiltration. Participants will be prospectively evaluated using a multiparametric monitoring strategy including clinical, hemodynamic, ultrasound, perfusion, and biochemical assessments. Patients will subsequently be classified according to the development or absence of ultrafiltration intolerance during the observation period.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Development of Ultrafiltration Intolerance
Zeitfenster: From UFNET initiation (T0) to 24 hours after initiation of net ultrafiltration
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.
From UFNET initiation (T0) to 24 hours after initiation of net ultrafiltration

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Incidence of Ultrafiltration Intolerance
Zeitfenster: From UFNET initiation (T0) to 24 hours.
Percentage of participants who develop ultrafiltration intolerance during the observation period.
From UFNET initiation (T0) to 24 hours.
Net Ultrafiltration Rate (mL/kg/h)
Zeitfenster: From UFNET initiation (T0) to 24 hours.
Prescribed and achieved net ultrafiltration rate during continuous renal replacement therapy.
From UFNET initiation (T0) to 24 hours.
Time to First Ultrafiltration Intolerance Event (hours)
Zeitfenster: From UFNET initiation to 24 hours.
Time from UFNET initiation to the first occurrence of ultrafiltration intolerance.
From UFNET initiation to 24 hours.
Severity Category of Ultrafiltration Intolerance
Zeitfenster: From UFNET initiation to 24 hours.
Proportion of participants classified as having mild, moderate, or severe ultrafiltration intolerance according to protocol-defined criteria. Higher categories indicate greater severity of intolerance.
From UFNET initiation to 24 hours.
Agreement Between Hypotension-Based and Hypoperfusion-Based Definitions of Ultrafiltration Intolerance
Zeitfenster: From UFNET initiation to 24 hours.
Agreement between intolerance defined by hypotension criteria and intolerance defined by tissue hypoperfusion criteria, assessed using Cohen's kappa coefficient.
From UFNET initiation to 24 hours.
Cumulative Fluid Balance (mL)
Zeitfenster: 24 hours after UFNET initiation
Cumulative fluid balance achieved during the first 24 hours following UFNET initiation.
24 hours after UFNET initiation
Achieved Net Ultrafiltration Volume (mL)
Zeitfenster: 24 hours after UFNET initiation
Total net ultrafiltration volume achieved during the observation period.
24 hours after UFNET initiation
Proportion of Participants Achieving Renal Recovery
Zeitfenster: Up to 90 days after UFNET initiation
Percentage of participants who recover kidney function sufficiently to discontinue kidney replacement therapy according to the treating clinical team.
Up to 90 days after UFNET initiation
Ventilator-Free Days
Zeitfenster: Up to 28 days after UFNET initiation
Number of days alive and free from invasive mechanical ventilation.
Up to 28 days after UFNET initiation
Intensive Care Unit Mortality
Zeitfenster: From UFNET initiation up to 90 days or ICU discharge, whichever occurs first
Percentage of participants who die during intensive care unit admission.
From UFNET initiation up to 90 days or ICU discharge, whichever occurs first
Hospital Mortality
Zeitfenster: From UFNET initiation until hospital discharge, assessed up to 180 days
Percentage of participants who die during hospital admission.
From UFNET initiation until hospital discharge, assessed up to 180 days

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Hospital Las Higueras

Ermittler

  • Hauptermittler: Gonzalo Ramírez-Guerrero, MD, Hospital Las Higueras de Talcahuano

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

6. Juli 2026

Primärer Abschluss (Geschätzt)

1. Dezember 2027

Studienabschluss (Geschätzt)

1. Dezember 2027

Studienanmeldedaten

Zuerst eingereicht

1. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

9. Juni 2026

Zuerst gepostet (Tatsächlich)

11. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

11. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

9. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • CEC-SST-15-2026

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

UNENTSCHIEDEN

Beschreibung des IPD-Plans

The investigators have not yet determined whether individual participant data (IPD) will be shared. Any future decision regarding data sharing will be made in accordance with institutional policies, ethical approvals, participant confidentiality requirements, and applicable regulations.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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