Venous Return Pressure Gradient as a Predictor of Acute Kidney Injury

N/ANot Yet RecruitingNCT07722325

Sichuan Academy of Medical Sciences180 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

180

Conditions

AKI - Acute Kidney Injury

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age ≥18 years 2. Admitted to the intensive care unit (ICU) within 48 hours 3. Central venous catheter in place for continuous central venous pressure (CVP) monitoring 4. Radial artery catheter in place for hemodynamic monitoring including mean systemic filling pressure (Pmsf) 5. No acute kidney injury (AKI) at ICU admission according to KDIGO criteria Exclusion Criteria: 1. Maintenance hemodialysis or continuous renal replacement therapy (CRRT) prior to ICU admission 2. Previous kidney transplantation 3. Pregnancy 4. Extracorporeal membrane oxygenation (ECMO) support at ICU admission 5. Incomplete core hemodynamic data precluding calculation of venous return pressure gradient (Pmsf-CVP) or AKI assessment

Outcomes

Primary Outcomes

Acute Kidney Injury occurrence

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.

Time frame: Within 48 hours of ICU admission

Secondary Outcomes

Persistent Acute Kidney Injury

Persistent AKI defined as failure of renal function to return to baseline within 48 hours after AKI occurrence during the ICU stay. The predictive value of venous return pressure gradient (Pmsf-CVP) for persistent AKI will be evaluated by ROC curve analysis.

Time frame: Within 48 hours after AKI occurrence during the ICU stay

AKI severity grade

Maximum AKI stage (KDIGO stage 1, 2, or 3) achieved during the ICU stay.

Time frame: At the time of maximum AKI stage during the ICU stay, up to 28 days

In-hospital mortality

All-cause mortality during the index hospitalization.

Time frame: From ICU admission to hospital discharge, up to 90 days

Total length of hospital stay

Number of days from hospital admission to hospital discharge or in-hospital death, whichever comes first. Patients still hospitalized at day 90 will be censored at 90 days.

Time frame: From hospital admission to discharge or death, up to 90 days

Correlation between venous return pressure gradient and serum creatinine

Spearman rank correlation analysis between Pmsf-CVP (measured within 48 hours of ICU admission) and serum creatinine levels (baseline creatinine at ICU admission and peak creatinine during ICU stay).

Time frame: Within 48 hours of ICU admission

Correlation between venous return pressure gradient and lactate

Spearman rank correlation analysis between Pmsf-CVP (measured within 48 hours of ICU admission) and lactate levels obtained from the first arterial blood gas analysis within 48 hours of ICU admission.

Time frame: Within 48 hours of ICU admission

Duration of mechanical ventilation

Number of days on invasive mechanical ventilation from the time of first intubation to the first successful extubation. Reintubation within 48 hours will be counted as continuous ventilation.

Time frame: From intubation to first successful extubation

Length of ICU stay

Number of days from ICU admission to ICU discharge.

Time frame: From ICU admission to ICU discharge

Venous Return Pressure Gradient as a Predictor of Acute Kidney Injury

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts