跳至主要内容
临床试验/NCT07643597
NCT07643597招募中不适用

Volume Removal Intolerance During Net Ultrafiltration in Acute Kidney Injury Patients

Hospital Las Higueras10 个研究点 分布在 7 个国家目标入组 128 人开始时间: 2026年7月6日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
128
试验地点
10

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

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.

研究者

发起方
Hospital Las Higueras
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gonzalo Ramirez Guerrero

Principal Investigator - Nephrologist

Hospital Las Higueras

研究点 (10)

Loading locations...

相似试验