Venous Return Pressure Gradient as a Predictor of Acute Kidney Injury

Official title

Venous Return Pressure Gradient Predicts Acute Kidney Injury Onset and Progression

Overview

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

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

Primary outcome measures

• Acute Kidney Injury occurrence [Time frame: Within 48 hours of ICU admission]

Secondary outcome measures (8)

• Persistent Acute Kidney Injury [Time frame: Within 48 hours after AKI occurrence during the ICU stay]
• AKI severity grade [Time frame: At the time of maximum AKI stage during the ICU stay, up to 28 days]
• In-hospital mortality [Time frame: From ICU admission to hospital discharge, up to 90 days]
• Total length of hospital stay [Time frame: From hospital admission to discharge or death, up to 90 days]
• Correlation between venous return pressure gradient and serum creatinine [Time frame: Within 48 hours of ICU admission]
• Correlation between venous return pressure gradient and lactate [Time frame: Within 48 hours of ICU admission]
• Duration of mechanical ventilation [Time frame: From intubation to first successful extubation]
• Length of ICU stay [Time frame: From ICU admission to ICU discharge]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• 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. PMID 26650057
• 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. PMID 38963533
• 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. PMID 30238174
• 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. PMID 21645384
• 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. PMID 24677557
• 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. PMID 36615175
• 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. PMID 37668397
• 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. PMID 25229340

Identifiers

NCT: NCT07722325 · IRB No. 321 (2026)

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗