Venous Return Pressure Gradient as a Predictor of Acute Kidney Injury

NCT07722325 | Not Yet Recruiting

• 1 other identifier: IRB No. 321 (2026)
• Study Type: observational
• Target: 180
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

AKI - Acute Kidney Injury

Keywords

Venous return pressure gradient; Acute kidney injury; Mean systemic filling pressure; Central venous pressure; Intensive care

Outcome Measures

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.

  Within 48 hours of ICU admission

Secondary Outcomes (8)

• Persistent Acute Kidney Injury

  Within 48 hours after AKI occurrence during the ICU stay

• AKI severity grade

  At the time of maximum AKI stage during the ICU stay, up to 28 days

• In-hospital mortality

  From ICU admission to hospital discharge, up to 90 days

• Total length of hospital stay

  From hospital admission to discharge or death, up to 90 days

• Correlation between venous return pressure gradient and serum creatinine

  Within 48 hours of ICU admission

Interventions

No study intervention OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sichuan Academy of Medical Sciences: lead

Related Publications (22)

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MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

rongan Liu

CONTACT

+8615928731511; 35279240@qq.com

chunling Chen

CONTACT

+8618349304972; cclblingk@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Physician, Intensive Care Unit

Study Record Dates

• First Submitted: June 30, 2026
• First Posted: July 23, 2026
• Study Start: July 5, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: July 23, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share