Venous Return Pressure Gradient as a Predictor of Acute Kidney Injury
ConditionAKI - Acute Kidney Injury
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSichuan Academy of Medical Sciences
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
Maintenance hemodialysis or continuous renal replacement therapy (CRRT) prior to ICU admission
Previous kidney transplantation
Pregnancy
Extracorporeal membrane oxygenation (ECMO) support at ICU admission
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
No study intervention
Other interventionNo study intervention. This is an observational cohort study using routine hemodynamic monitoring data (Pmsf and CVP) collected during standard clinical care.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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 admissionSecondary outcomes
1
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 stay2
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 days3
In-hospital mortality
All-cause mortality during the index hospitalization.
Time frame
From ICU admission to hospital discharge, up to 90 days4
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 daysLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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