NCT07855653

Brief Summary

Contrast-associated acute kidney injury (CA-AKI) is a potential complication that can occur following exposure to iodinated contrast media during diagnostic and interventional procedures, contributing to prolonged hospital stays, increased morbidity, and higher mortality. Although several clinical risk factors are well-recognized, pre-procedural risk stratification remains challenging. The serum uric acid-to-albumin ratio (UAR) has emerged as a composite biomarker reflecting oxidative stress and inflammation that may help identify vulnerable patients prior to contrast exposure. The primary purpose of this prospective observational cohort study is to evaluate the predictive performance of the pre-procedural uric acid-to-albumin ratio for the development of contrast-associated acute kidney injury. The study will also compare the predictive value of UAR between patients undergoing cardiac procedures, specifically percutaneous coronary intervention (PCI), and those undergoing non-cardiac contrast procedures. A total of 100 adult participants will be enrolled across two groups: 50 patients undergoing PCI and 50 patients undergoing non-cardiac contrast procedures. Baseline venous blood samples will be obtained prior to the procedure to measure serum creatinine, uric acid, and albumin levels. Follow-up kidney function tests will be evaluated at 48 and 72 hours post-procedure to detect the development of CA-AKI and assess the diagnostic accuracy of pre-procedural UAR.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
13mo left

Started Nov 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 2, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2026

Expected
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2027

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

October 2, 2026

Status Verified

September 1, 2026

Enrollment Period

1 year

First QC Date

September 28, 2026

Last Update Submit

September 28, 2026

Conditions

Keywords

Uric acid to albumin ratioUARContrast-associated acute kidney injuryPercutaneous coronary interventionIodinated contrast mediaCardiac catheterizationMehran risk score

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Contrast-Associated Acute Kidney Injury (CA-AKI)

    Defined as an absolute increase in serum creatinine of at least 0.5 mg/dL (44.2 micromol/L) or a relative increase of at least 25% from baseline, evaluated within 72 hours following iodinated contrast media exposure.

    72 hours post-procedure

Study Arms (2)

Cardiac Group (PCI)

Adult patients undergoing percutaneous coronary intervention (PCI) requiring exposure to iodinated contrast media. Baseline serum creatinine, uric acid, and albumin are measured pre-procedure, and renal function is monitored at 48 and 72 hours post-procedure to assess the development of contrast-associated acute kidney injury (CA-AKI).

Non-Cardiac Group

Adult patients undergoing non-cardiac diagnostic or interventional procedures requiring exposure to iodinated contrast media. Baseline serum creatinine, uric acid, and albumin are measured pre-procedure, and renal function is monitored at 48 and 72 hours post-procedure to assess the development of contrast-associated acute kidney injury (CA-AKI).

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients admitted to or evaluated at the Internal Medicine Department and related catheterization and interventional units at Assiut University Hospital who are scheduled to undergo cardiac (percutaneous coronary intervention) or non-cardiac diagnostic and interventional procedures requiring exposure to iodinated contrast media.

You may qualify if:

  • Adult patients aged 18 years or older undergoing a cardiac or non-cardiac procedure requiring iodinated contrast media.
  • Cardiac group: patients undergoing percutaneous coronary intervention (PCI).
  • Non-cardiac group: patients undergoing other diagnostic or interventional contrast procedures.
  • Provision of written informed consent prior to enrollment.
  • Available baseline (pre-procedural) serum creatinine, uric acid, and albumin measurements.

You may not qualify if:

  • Severe chronic kidney disease or end-stage renal disease on regular maintenance hemodialysis (baseline eGFR \< 15 mL/min/1.73 m\^2).
  • Exposure to iodinated contrast media within the preceding 7 to 10 days.
  • Acute kidney injury from any cause present at admission or prior to contrast exposure.
  • Active infection, sepsis, or systemic inflammatory response syndrome at the time of enrollment.
  • Known history of gout, current use of urate-lowering therapy, or hematologic malignancy affecting uric acid metabolism.
  • Severe hepatic disease or marked proteinuria affecting serum albumin independently of the study condition.
  • Emergent PCI where baseline laboratory samples could not be obtained prior to contrast exposure.
  • Patient death occurring before the 48 to 72 hour post-procedural serum creatinine evaluation could be performed.
  • Pregnancy.
  • Refusal of informed consent or loss to follow-up prior to outcome assessment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident

Study Record Dates

First Submitted

September 28, 2026

First Posted

October 2, 2026

Study Start (Estimated)

November 1, 2026

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

October 2, 2026

Record last verified: 2026-09