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临床试验/NCT07722325
NCT07722325尚未招募不适用

Venous Return Pressure Gradient Predicts Acute Kidney Injury Onset and Progression

Sichuan Academy of Medical Sciences0 个研究点目标入组 180 人开始时间: 2026年7月5日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
180
主要终点
Acute Kidney Injury occurrence

研究概览

简要总结

Acute kidney injury (AKI) is a common and serious complication in the ICU. Current diagnostic indicators (such as creatinine and urine output) exhibit significant lag, and specific hemodynamic predictive markers are lacking. The venous return pressure gradient (Pmsf-CVP), based on Guyton's theory, reflects the driving pressure for venous return; however, its value in the early warning of AKI remains unclear. This study aims to investigate the predictive value of the venous return pressure gradient for the onset and progression of AKI in ICU patients, and to clarify its effectiveness as an AKI risk warning indicator.

Patients admitted to the ICU within 48 hours with risk factors for AKI (including sepsis, shock, major surgery, underlying diseases, etc.) who have radial artery catheterization and can undergo hemodynamic monitoring will be enrolled. Those undergoing maintenance dialysis/CRRT, ECMO support, or with missing core data precluding calculation of Pmsf-CVP or AKI assessment will be excluded.

The venous return pressure gradient (Pmsf-CVP, mmHg) will be measured within 48 hours of ICU admission using the transient stop-flow arm arterial-venous equilibrium pressure method. The primary outcome is to evaluate the association between the venous return pressure gradient level and AKI occurrence. Secondary outcomes include correlation analyses between the venous return pressure gradient level and serum creatinine and urine output within 48 hours of ICU admission, among others.

研究设计

研究类型
Observational
观察模型
Cohort
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
  • Admitted to the intensive care unit (ICU) within 48 hours
  • Central venous catheter in place for continuous central venous pressure (CVP) monitoring
  • Radial artery catheter in place for hemodynamic monitoring including mean systemic filling pressure (Pmsf)
  • No acute kidney injury (AKI) at ICU admission according to KDIGO criteria

排除标准

  • Maintenance hemodialysis or continuous renal replacement therapy (CRRT) prior to ICU admission
  • Previous kidney transplantation
  • Extracorporeal membrane oxygenation (ECMO) support at ICU admission
  • Incomplete core hemodynamic data precluding calculation of venous return pressure gradient (Pmsf-CVP) or AKI assessment

结局指标

主要结局

Acute Kidney Injury occurrence

时间窗: Within 48 hours of ICU admission

Occurrence of acute kidney injury diagnosed according to KDIGO criteria (serum creatinine increase ≥1.5 times baseline, or ≥26 μmol/L within 48 hours, or urine output \<0.5 mL/kg/h for ≥6 hours) during the ICU stay. The association between venous return pressure gradient (Pmsf-CVP, measured within the first 48 hours of ICU admission using the Pmsf-arm method) and AKI occurrence will be assessed by multivariable logistic regression analysis, adjusting for APACHE II score, baseline serum creatinine, lactate, mean arterial pressure, sepsis, and shock.

次要结局

  • Persistent Acute Kidney Injury(Within 48 hours after AKI occurrence during the ICU stay)
  • AKI severity grade(At the time of maximum AKI stage during the ICU stay, up to 28 days)
  • In-hospital mortality(From ICU admission to hospital discharge, up to 90 days)
  • Total length of hospital stay(From hospital admission to discharge or death, up to 90 days)
  • Correlation between venous return pressure gradient and serum creatinine(Within 48 hours of ICU admission)
  • Correlation between venous return pressure gradient and lactate(Within 48 hours of ICU admission)
  • Duration of mechanical ventilation(From intubation to first successful extubation)
  • Length of ICU stay(From ICU admission to ICU discharge)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rongan Liu

Associate Chief Physician, Intensive Care Unit

Sichuan Academy of Medical Sciences

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