Esta página foi traduzida automaticamente e a precisão da tradução não é garantida. Por favor, consulte o versão em inglês para um texto fonte.

Venous Return Pressure Gradient as a Predictor of Acute Kidney Injury (VRPG-AKI)

22 de julho de 2026 atualizado por: 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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

LRA - Lesão Renal Aguda

Intervenção / Tratamento

Outro: No study intervention

Tipo de estudo

Observacional

Inscrição (Estimado)

180

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Nome: rongan Liu
Número de telefone: +8615928731511
E-mail: 35279240@qq.com

Estude backup de contato

Nome: chunling Chen
Número de telefone: +8618349304972
E-mail: cclblingk@163.com

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

Adulto
Adulto mais velho

Aceita Voluntários Saudáveis

Não

Método de amostragem

Amostra Não Probabilística

População do estudo

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.

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado	Descrição da medida	Prazo
Acute Kidney Injury occurrence Prazo: 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.	Within 48 hours of ICU admission

Medidas de resultados secundários

Medida de resultado	Descrição da medida	Prazo
Persistent Acute Kidney Injury Prazo: 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.	Within 48 hours after AKI occurrence during the ICU stay
AKI severity grade Prazo: 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.	At the time of maximum AKI stage during the ICU stay, up to 28 days
In-hospital mortality Prazo: From ICU admission to hospital discharge, up to 90 days	All-cause mortality during the index hospitalization.	From ICU admission to hospital discharge, up to 90 days
Total length of hospital stay Prazo: 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.	From hospital admission to discharge or death, up to 90 days
Correlation between venous return pressure gradient and serum creatinine Prazo: 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).	Within 48 hours of ICU admission
Correlation between venous return pressure gradient and lactate Prazo: 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.	Within 48 hours of ICU admission
Duration of mechanical ventilation Prazo: 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.	From intubation to first successful extubation
Length of ICU stay Prazo: From ICU admission to ICU discharge	Number of days from ICU admission to ICU discharge.	From ICU admission to ICU discharge

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Sichuan Academy of Medical Sciences

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

5 de julho de 2026

Conclusão Primária (Estimado)

1 de maio de 2027

Conclusão do estudo (Estimado)

1 de maio de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

30 de junho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

22 de julho de 2026

Primeira postagem (Real)

23 de julho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)