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NCT Number: NCT07722325

Venous Return Pressure Gradient as a Predictor of Acute Kidney Injury

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.

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Key information

Conditions

AKI - Acute Kidney Injury Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

No study intervention

Other

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

Primary outcomes

  1. Acute Kidney Injury occurrence

    Time frame: 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.

Secondary outcomes

  1. Persistent Acute Kidney Injury

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

    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.

  2. AKI severity grade

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

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

  3. In-hospital mortality

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

    All-cause mortality during the index hospitalization.

  4. Total length of hospital stay

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

    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.

  5. Correlation between venous return pressure gradient and serum creatinine

    Time frame: Within 48 hours of ICU admission

    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).

  6. Correlation between venous return pressure gradient and lactate

    Time frame: Within 48 hours of ICU admission

    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.

  7. Duration of mechanical ventilation

    Time frame: From intubation to first successful extubation

    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.

  8. Length of ICU stay

    Time frame: From ICU admission to ICU discharge

    Number of days from ICU admission to ICU discharge.

Study contacts

Contact information is provided by the study sponsor or research team.

chunling Chen

CONTACT

[email protected]

+8618349304972

rongan Liu

CONTACT

[email protected]

+8615928731511

Sponsors and collaborators

Lead sponsor

Sichuan Academy of Medical Sciences

Other

Registry information

Official study title

Venous Return Pressure Gradient Predicts Acute Kidney Injury Onset and Progression

Acronym: VRPG-AKI

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 23, 2026
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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