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

2026年6月9日更新者：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.

調査の概要

状態

まだ募集していません

条件

詳細な説明

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.

研究の種類

観察的

入学 (推定)

128

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

名前：Gonzalo Ramírez-Guerrero, MD
電話番号：+56981746173
メール：ramirezguerrero.g@gmail.com

研究連絡先のバックアップ

名前：Cristian Pedreros-Rosales, MD
メール：cpedreros@me.com

研究場所

イタリア
- - Vicenza、イタリア
    - Ospedale San Bortolo
    - コンタクト：
      
      Matteo Marcello, MD
      
      電話番号：+393925743247
      
      メール：matteo.marcello92@gmail.com
エクアドル
- - Quito、エクアドル
    - Hospital General Enrique Garces
    - コンタクト：
      
      Darío Jiménez, MD
      
      電話番号：+593992773176
      
      メール：dxjimenezmd@gmail.com
コロンビア
- - Popayán、コロンビア
    - Hospital Universitario San José de Popayán
    - コンタクト：
      
      David Ballesteros, MD
      
      電話番号：+573105542506
      
      メール：david.ballesteros.c@gmail.com
チリ
- - Concepción、チリ
    - Hospital Clínico Regional de Concepción
    - コンタクト：
      
      Marcos Hernandez, MD
      
      電話番号：+56976685604
      
      メール：md.hernandezdiaz@gmail.com
  - Los Ángeles、チリ
    - Complejo Asistencial Dr. Victor Ríos Ruiz
    - コンタクト：
      
      Carolina Carrasco, MD
      
      電話番号：+56975583888
      
      メール：carolina.carrascoa@gmail.com
  - Santiago、チリ
    - Hospital Clínico Dra. Eloísa Díaz Insunza de La Florida
    - コンタクト：
      
      Eduardo Chinchón, MD
      
      電話番号：+56994514773
      
      メール：doctorchinchon@gmail.com
  - Talcahuano、チリ
    - Hospital Las Higueras de Talcahuano
    - コンタクト：
      
      Gonzalo Ramírez-Guerrero, MD
      
      電話番号：+56981746173
      
      メール：ramirezguerrero.g@gmail.com
    - コンタクト：
      
      Cristian Pedreros-Rosales, MD
      
      メール：cpedreros@me.com
    - 副調査官：
      
      Rodrigo Ulloa, MD
    - 副調査官：
      
      Jonathan Alarcón, MD
    - 副調査官：
      
      Ricardo Ferrada, MD
ブラジル
- - Salvador、ブラジル
    - Hospital Cárdio Pulmonar
    - コンタクト：
      
      Maria Gabriela Guimarães, MD
      
      電話番号：+5571982121211
      
      メール：Gabrielaguimar@hotmail.com
ペルー
- - Lima、ペルー
    - Hospital Nacional Cayetano Heredia
    - コンタクト：
      
      Raúl Valenzuela, MD
      
      電話番号：+51999308278
      
      メール：raul.valenzuela.cordova@gmail.com
メキシコ
- - Mexico City、メキシコ
    - Hospital General de Mexico
    - コンタクト：
      
      Pablo Galindo, MD
      
      電話番号：+525551564682
      
      メール：drgalindo@nefrologoscdmx.com

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

大人
高齢者

健康ボランティアの受け入れ

いいえ

サンプリング方法

非確率サンプル

調査対象母集団

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.

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

グループ/コホートの数

コホートと介入

グループ/コホート
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.

グループ/コホート

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.

この研究は何を測定していますか？

主要な結果の測定

結果測定	メジャーの説明	時間枠
Development of Ultrafiltration Intolerance 時間枠：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

二次結果の測定

結果測定	メジャーの説明	時間枠
Incidence of Ultrafiltration Intolerance 時間枠：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) 時間枠：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) 時間枠：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 時間枠：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 時間枠：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) 時間枠：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) 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Hospital Las Higueras

捜査官

主任研究者：Gonzalo Ramírez-Guerrero, MD、Hospital Las Higueras de Talcahuano

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年7月6日

一次修了 (推定)

2027年12月1日

研究の完了 (推定)

2027年12月1日

試験登録日

最初に提出

2026年6月1日

QC基準を満たした最初の提出物

2026年6月9日

最初の投稿 (実際)

2026年6月11日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月11日

QC基準を満たした最後の更新が送信されました

2026年6月9日

最終確認日