An observational study in AKI - Acute Kidney Injury, sponsored by Sichuan Academy of Medical Sciences. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-23.
Sponsored by Sichuan Academy of Medical Sciences · Observational
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.
1,595 studies on the registry are indexed under Acute Kidney Injury; 371 are open to participants now.
This study's planned enrollment of 180 is above the median of 150 across 773 observational studies indexed under Acute Kidney Injury.
Browse Acute Kidney Injury studies →Sichuan Academy of Medical Sciences is the lead sponsor of 16 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
No study intervention. This is an observational cohort study using routine hemodynamic monitoring data (Pmsf and CVP) collected during standard clinical care.
Acute Kidney Injury occurrence
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.
Time frame: Within 48 hours of ICU admission
Persistent Acute Kidney Injury
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.
Time frame: Within 48 hours after AKI occurrence during the ICU stay
AKI severity grade
Maximum AKI stage (KDIGO stage 1, 2, or 3) achieved during the ICU stay.
Time frame: At the time of maximum AKI stage during the ICU stay, up to 28 days
In-hospital mortality
All-cause mortality during the index hospitalization.
Time frame: From ICU admission to hospital discharge, up to 90 days
Total length of hospital stay
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.
Time frame: From hospital admission to discharge or death, up to 90 days
Correlation between venous return pressure gradient and serum creatinine
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).
Time frame: Within 48 hours of ICU admission
Correlation between venous return pressure gradient and lactate
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.
Time frame: Within 48 hours of ICU admission
Duration of mechanical ventilation
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.
Time frame: From intubation to first successful extubation
Length of ICU stay
Number of days from ICU admission to ICU discharge.
Time frame: From ICU admission to ICU discharge
No study locations are listed for this record.
Plan to share: No
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Sichuan Academy of Medical Sciences