NCT06596785

Brief Summary

Contrast-associated acute kidney injury (CI-AKI) is a sudden and significant decline in renal function resulting from the use of a contrast agent.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
active not 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

Study Start

First participant enrolled

June 1, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

9 months

First QC Date

September 8, 2024

Last Update Submit

September 11, 2024

Conditions

AKI - Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

  • AKI

    During the patient's hospitalization, acute kidney injury occurred after the use of Iodinated contrast media

    Completed through study, up to half a year

Eligibility Criteria

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

hospital

You may qualify if:

  • patients who received iodinated contrast agents during hospitalization
  • age ≥ 18 years
  • hospitalization length ≥ 48 hours
  • at least two serum creatinine tests during hospitalization

You may not qualify if:

  • patients with stage 4 or 5 chronic kidney disease prior to admission
  • patients undergoing hemodialysis, hemofiltration or peritoneal before admission
  • a history of nephrectomy or kidney transplantation during hospitalization
  • incomplete clinical information
  • Serum creatinine always ≤ 40 μmol/L during hospitalization

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital

Jinan, Shandong, 250014, China

Location

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

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

Study Officials

  • Xiao Lii

    Qianfoshan Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate professor of pharmacy

Study Record Dates

First Submitted

September 8, 2024

First Posted

September 19, 2024

Study Start

June 1, 2024

Primary Completion

March 1, 2025

Study Completion

June 1, 2025

Last Updated

September 19, 2024

Record last verified: 2024-09

Locations

CN(1)