Venous Return Pressure Gradient as a Predictor of Acute Kidney Injury (VRPG-AKI)
22 de julio de 2026 actualizado 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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
De observación
Inscripción (Estimado)
180
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: rongan Liu
- Número de teléfono: +8615928731511
- Correo electrónico: 35279240@qq.com
Copia de seguridad de contactos de estudio
- Nombre: chunling Chen
- Número de teléfono: +8618349304972
- Correo electrónico: cclblingk@163.com
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Método de muestreo
Muestra no probabilística
Población de estudio
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.
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Acute Kidney Injury occurrence
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Persistent Acute Kidney Injury
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
|
Duration of mechanical ventilation
Periodo de tiempo: 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
Periodo de tiempo: From ICU admission to ICU discharge
|
Number of days from ICU admission to ICU discharge.
|
From ICU admission to ICU discharge
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
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- Hoste EA, Bagshaw SM, Bellomo R, Cely CM, Colman R, Cruz DN, Edipidis K, Forni LG, Gomersall CD, Govil D, Honore PM, Joannes-Boyau O, Joannidis M, Korhonen AM, Lavrentieva A, Mehta RL, Palevsky P, Roessler E, Ronco C, Uchino S, Vazquez JA, Vidal Andrade E, Webb S, Kellum JA. Epidemiology of acute kidney injury in critically ill patients: the multinational AKI-EPI study. Intensive Care Med. 2015 Aug;41(8):1411-23. doi: 10.1007/s00134-015-3934-7. Epub 2015 Jul 11.
- Eskesen TG, Wetterslev M, Perner A. Systematic review including re-analyses of 1148 individual data sets of central venous pressure as a predictor of fluid responsiveness. Intensive Care Med. 2016 Mar;42(3):324-332. doi: 10.1007/s00134-015-4168-4. Epub 2015 Dec 9.
- Magder S. The use of Guyton's approach to the control of cardiac output for clinical fluid management. Ann Intensive Care. 2024 Jul 4;14(1):105. doi: 10.1186/s13613-024-01316-z.
- Chen X, Wang X, Honore PM, Spapen HD, Liu D. Renal failure in critically ill patients, beware of applying (central venous) pressure on the kidney. Ann Intensive Care. 2018 Sep 20;8(1):91. doi: 10.1186/s13613-018-0439-x.
- Badin J, Boulain T, Ehrmann S, Skarzynski M, Bretagnol A, Buret J, Benzekri-Lefevre D, Mercier E, Runge I, Garot D, Mathonnet A, Dequin PF, Perrotin D. Relation between mean arterial pressure and renal function in the early phase of shock: a prospective, explorative cohort study. Crit Care. 2011;15(3):R135. doi: 10.1186/cc10253. Epub 2011 Jun 6.
- Wonnacott A, Meran S, Amphlett B, Talabani B, Phillips A. Epidemiology and outcomes in community-acquired versus hospital-acquired AKI. Clin J Am Soc Nephrol. 2014 Jun 6;9(6):1007-14. doi: 10.2215/CJN.07920713. Epub 2014 Mar 27.
- Turgut F, Awad AS, Abdel-Rahman EM. Acute Kidney Injury: Medical Causes and Pathogenesis. J Clin Med. 2023 Jan 3;12(1):375. doi: 10.3390/jcm12010375.
- Rossiter A, La A, Koyner JL, Forni LG. New biomarkers in acute kidney injury. Crit Rev Clin Lab Sci. 2024 Jan;61(1):23-44. doi: 10.1080/10408363.2023.2242481. Epub 2023 Sep 5.
- Siew ED, Davenport A. The growth of acute kidney injury: a rising tide or just closer attention to detail? Kidney Int. 2015 Jan;87(1):46-61. doi: 10.1038/ki.2014.293. Epub 2014 Sep 17.
- Coca SG, Singanamala S, Parikh CR. Chronic kidney disease after acute kidney injury: a systematic review and meta-analysis. Kidney Int. 2012 Mar;81(5):442-8. doi: 10.1038/ki.2011.379. Epub 2011 Nov 23.
- Cerda J, Kashani K, Ostermann M, Basu RK, Bell S, Cantaluppi V, Chakaravarthi R, Costa JM, Claure-Del Granado R, Macedo E, Rhee H, Srisawat N, Wu VC, Yang L, Mehta RL. The global epidemiology of acute kidney injury: challenges and opportunities. Nat Rev Nephrol. 2026 Mar;22(3):179-198. doi: 10.1038/s41581-025-01030-4. Epub 2025 Dec 5.
- Chen KP, Cavender S, Lee J, Feng M, Mark RG, Celi LA, Mukamal KJ, Danziger J. Peripheral Edema, Central Venous Pressure, and Risk of AKI in Critical Illness. Clin J Am Soc Nephrol. 2016 Apr 7;11(4):602-8. doi: 10.2215/CJN.08080715. Epub 2016 Jan 19.
- Goeddel LA, Hernandez M, Koffman L, Murphy Z, Khanna AK, Robich M, Whitman G, Zhou X, Bandeen-Roche K, Muschelli J 3rd, Parikh CR, Lima JAC, Crainiceanu CM, Brown C 4th, Faraday N. Fine-Mapping the Association of Acute Kidney Injury With Mean Arterial and Central Venous Pressures During Coronary Artery Bypass Surgery. Anesth Analg. 2025 Jun 1;140(6):1439-1449. doi: 10.1213/ANE.0000000000007500. Epub 2025 Apr 17.
- Bolanos G F, de Pastrana SL. [Classification, diagnostic criteria and some therapeutic considerations of the solitary thyroid nodulf (author's transl)]. Rev Invest Clin. 1976 Oct-Dec;28(4):341-5. No abstract available. Spanish.
- Cops J, Mullens W, Verbrugge FH, Swennen Q, De Moor B, Reynders C, Penders J, Achten R, Driessen A, Dendooven A, Rigo JM, Hansen D. Selective abdominal venous congestion induces adverse renal and hepatic morphological and functional alterations despite a preserved cardiac function. Sci Rep. 2018 Dec 10;8(1):17757. doi: 10.1038/s41598-018-36189-3.
- Magder S, Slobod D, Vieillard-Baron A. Physiological and clinical significance of mean circulatory and mean systemic filling pressure. Ann Intensive Care. 2025 Nov 24;15(1):187. doi: 10.1186/s13613-025-01595-0.
- Damman K, Navis G, Smilde TD, Voors AA, van der Bij W, van Veldhuisen DJ, Hillege HL. Decreased cardiac output, venous congestion and the association with renal impairment in patients with cardiac dysfunction. Eur J Heart Fail. 2007 Sep;9(9):872-8. doi: 10.1016/j.ejheart.2007.05.010. Epub 2007 Jun 22.
- Panwar R, McNicholas B, Teixeira JP, Kansal A. Renal perfusion pressure: role and implications in critical illness. Ann Intensive Care. 2025 Aug 8;15(1):115. doi: 10.1186/s13613-025-01535-y.
- Chen CY, Zhou Y, Wang P, Qi EY, Gu WJ. Elevated central venous pressure is associated with increased mortality and acute kidney injury in critically ill patients: a meta-analysis. Crit Care. 2020 Mar 5;24(1):80. doi: 10.1186/s13054-020-2770-5.
- Legrand M, Dupuis C, Simon C, Gayat E, Mateo J, Lukaszewicz AC, Payen D. Association between systemic hemodynamics and septic acute kidney injury in critically ill patients: a retrospective observational study. Crit Care. 2013 Nov 29;17(6):R278. doi: 10.1186/cc13133.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
5 de julio de 2026
Finalización primaria (Estimado)
1 de mayo de 2027
Finalización del estudio (Estimado)
1 de mayo de 2027
Fechas de registro del estudio
Enviado por primera vez
30 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
22 de julio de 2026
Publicado por primera vez (Actual)
23 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
23 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
22 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IRB No. 321 (2026)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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