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Venous Return Pressure Gradient as a Predictor of Acute Kidney Injury

Venous Return Pressure Gradient Predicts Acute Kidney Injury Onset and Progression

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07722325
Acronym
VRPG-AKI
Enrollment
180
Registered
2026-07-23
Start date
2026-07-05
Completion date
2027-05-01
Last updated
2026-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

AKI - Acute Kidney Injury

Keywords

Venous return pressure gradient, Acute kidney injury, Mean systemic filling pressure, Central venous pressure, Intensive care

Brief summary

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.

Interventions

No study intervention. This is an observational cohort study using routine hemodynamic monitoring data (Pmsf and CVP) collected during standard clinical care.

Sponsors

Sichuan Academy of Medical Sciences
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Acute Kidney Injury occurrenceWithin 48 hours of ICU admissionOccurrence 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.

Secondary

MeasureTime frameDescription
Persistent Acute Kidney InjuryWithin 48 hours after AKI occurrence during the ICU stayPersistent 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.
AKI severity gradeAt the time of maximum AKI stage during the ICU stay, up to 28 daysMaximum AKI stage (KDIGO stage 1, 2, or 3) achieved during the ICU stay.
In-hospital mortalityFrom ICU admission to hospital discharge, up to 90 daysAll-cause mortality during the index hospitalization.
Total length of hospital stayFrom hospital admission to discharge or death, up to 90 daysNumber 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.
Correlation between venous return pressure gradient and serum creatinineWithin 48 hours of ICU admissionSpearman 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).
Correlation between venous return pressure gradient and lactateWithin 48 hours of ICU admissionSpearman 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.
Duration of mechanical ventilationFrom intubation to first successful extubationNumber 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.
Length of ICU stayFrom ICU admission to ICU dischargeNumber of days from ICU admission to ICU discharge.

Contacts

CONTACTrongan Liu
35279240@qq.com+8615928731511
CONTACTchunling Chen
cclblingk@163.com+8618349304972

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 24, 2026