Venous Return Pressure Gradient as a Predictor of Acute Kidney Injury (VRPG-AKI)
22 luglio 2026 aggiornato da: Rongan Liu, Sichuan Academy of Medical Sciences
Venous Return Pressure Gradient Predicts Acute Kidney Injury Onset and Progression
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.
Panoramica dello studio
Stato
Stato
Non ancora reclutamento
Condizioni
Condizioni
Intervento / Trattamento
Intervento / Trattamento
Tipo di studio
Tipo di studio
Osservativo
Iscrizione (Stimato)
Iscrizione
180
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
Contatto studio
- Nome: rongan Liu
- Numero di telefono: +8615928731511
- Email: 35279240@qq.com
Backup dei contatti dello studio
- Nome: chunling Chen
- Numero di telefono: +8618349304972
- Email: cclblingk@163.com
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Metodo di campionamento
Campione non probabilistico
Popolazione di studio
Adult ICU patients (age ≥18 years) at risk for acute kidney injury, with central venous and radial arterial catheters in place for hemodynamic monitoring, no AKI at ICU admission per KDIGO criteria, and complete data available for calculation of venous return pressure gradient (Pmsf-CVP) within 48 hours of admission.
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
Cosa sta misurando lo studio?
Misure di risultato primarie
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Acute Kidney Injury occurrence
Lasso di tempo: 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.
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Within 48 hours of ICU admission
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Misure di risultato secondarie
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Persistent Acute Kidney Injury
Lasso di tempo: 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.
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Within 48 hours after AKI occurrence during the ICU stay
|
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AKI severity grade
Lasso di tempo: At the time of maximum AKI stage during the ICU stay, up to 28 days
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Maximum AKI stage (KDIGO stage 1, 2, or 3) achieved during the ICU stay.
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At the time of maximum AKI stage during the ICU stay, up to 28 days
|
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In-hospital mortality
Lasso di tempo: From ICU admission to hospital discharge, up to 90 days
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All-cause mortality during the index hospitalization.
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From ICU admission to hospital discharge, up to 90 days
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Total length of hospital stay
Lasso di tempo: From hospital admission to discharge or death, up to 90 days
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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.
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From hospital admission to discharge or death, up to 90 days
|
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Correlation between venous return pressure gradient and serum creatinine
Lasso di tempo: 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).
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Within 48 hours of ICU admission
|
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Correlation between venous return pressure gradient and lactate
Lasso di tempo: 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.
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Within 48 hours of ICU admission
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Duration of mechanical ventilation
Lasso di tempo: From intubation to first successful extubation
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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.
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From intubation to first successful extubation
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Length of ICU stay
Lasso di tempo: From ICU admission to ICU discharge
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Number of days from ICU admission to ICU discharge.
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From ICU admission to ICU discharge
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Sponsor
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
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Inizio studio (Stimato)
Inizio studio
5 luglio 2026
Completamento primario (Stimato)
Completamento primario
1 maggio 2027
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Completamento dello studio
1 maggio 2027
Date di iscrizione allo studio
Primo inviato
Primo inviato
30 giugno 2026
Primo inviato che soddisfa i criteri di controllo qualità
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22 luglio 2026
Primo Inserito (Effettivo)
Primo Inserito
23 luglio 2026
Aggiornamenti dei record di studio
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Ultimo aggiornamento pubblicato
23 luglio 2026
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Ultimo aggiornamento inviato che soddisfa i criteri QC
22 luglio 2026
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Ultimo verificato
1 luglio 2026
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Altri numeri di identificazione dello studio
Altri numeri di identificazione dello studio
- IRB No. 321 (2026)
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