NCT04606056

Brief Summary

Intravenous iodinated contrast media is commonly used to enhance diagnostic yield of computer tomography (CT) scans in clinical medicine. However, the perceived risk of contrast-induced nephropathy (CIN) frequently limits its use. While CIN is often self-limiting, it can cause significant morbidity by prolonging admissions and rendering an at-risk individual dialysis dependent. CIN has long been observed and described in clinical studies. There is ample data on CIN after administration of intraarterial contrast, but evidence is less compelling when it comes to intravenous contrast. Increasing studies have called into question the actual risk of intravenous contrast media. Expert panels are suggesting that the risk could have been overstated, leading to contrast being withheld when indicated. There is paucity of local data on this particular issue. More real world data on the actual incidence and risk factors of AKI will be helpful to clinicians. The investigators plan to conduct a single center, retrospective study, to determine the incidence and risk factors of post contrast AKI in contrast enhanced CT scans.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
2mo left

Started May 2023

Typical duration 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 Progress95%
May 2023Jun 2026

First Submitted

Initial submission to the registry

October 25, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 28, 2020

Completed
2.6 years until next milestone

Study Start

First participant enrolled

May 31, 2023

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Expected
Last Updated

January 3, 2024

Status Verified

January 1, 2024

Enrollment Period

2.1 years

First QC Date

October 25, 2020

Last Update Submit

January 1, 2024

Conditions

Keywords

Intravenouscontrastacute kidney injurycomputer tomography

Outcome Measures

Primary Outcomes (1)

  • Incidence of acute kidney injury

    within 1 week after contrast exposure

    31 May 2020 to 30 June 2020

Study Arms (1)

Patients who underwent contrast enhanced CT scans

Eligibility Criteria

Age13 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Any patient of an acute care hospital with clinical indications for contrast enchanced CT scans, meeting inclusion and exclusion criteria.

You may qualify if:

  • Underwent one or more CT scan in CGH in the stipulated study period
  • CT scan done as an inpatient or outpatient of CGH
  • Serum creatinine available less than 6 months before scan
  • Serum creatinine available within 1 week after scan

You may not qualify if:

  • Age 12 or below
  • Dialysis dependent before scan (dialysis related charge code applied 24 months before scan)
  • Baseline serum creatinine not available
  • Post scan serum creatinine not available

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Changi General Hospital

Singapore, 529889, Singapore

Location

Related Publications (7)

  • Davenport MS, Khalatbari S, Dillman JR, Cohan RH, Caoili EM, Ellis JH. Contrast material-induced nephrotoxicity and intravenous low-osmolality iodinated contrast material. Radiology. 2013 Apr;267(1):94-105. doi: 10.1148/radiol.12121394. Epub 2013 Jan 29.

    PMID: 23360737BACKGROUND
  • McDonald JS, McDonald RJ, Carter RE, Katzberg RW, Kallmes DF, Williamson EE. Risk of intravenous contrast material-mediated acute kidney injury: a propensity score-matched study stratified by baseline-estimated glomerular filtration rate. Radiology. 2014 Apr;271(1):65-73. doi: 10.1148/radiol.13130775. Epub 2014 Jan 16.

    PMID: 24475854BACKGROUND
  • Mehran R, Aymong ED, Nikolsky E, Lasic Z, Iakovou I, Fahy M, Mintz GS, Lansky AJ, Moses JW, Stone GW, Leon MB, Dangas G. A simple risk score for prediction of contrast-induced nephropathy after percutaneous coronary intervention: development and initial validation. J Am Coll Cardiol. 2004 Oct 6;44(7):1393-9. doi: 10.1016/j.jacc.2004.06.068.

    PMID: 15464318BACKGROUND
  • Leow KS, Wu YW, Tan CH. Renal-related adverse effects of intravenous contrast media in computed tomography. Singapore Med J. 2015 Apr;56(4):186-93. doi: 10.11622/smedj.2015057.

    PMID: 25917468BACKGROUND
  • Davenport MS, Khalatbari S, Cohan RH, Dillman JR, Myles JD, Ellis JH. Contrast material-induced nephrotoxicity and intravenous low-osmolality iodinated contrast material: risk stratification by using estimated glomerular filtration rate. Radiology. 2013 Sep;268(3):719-28. doi: 10.1148/radiol.13122276. Epub 2013 Apr 11.

    PMID: 23579046BACKGROUND
  • Davenport MS, Perazella MA, Yee J, Dillman JR, Fine D, McDonald RJ, Rodby RA, Wang CL, Weinreb JC. Use of Intravenous Iodinated Contrast Media in Patients With Kidney Disease: Consensus Statements from the American College of Radiology and the National Kidney Foundation. Kidney Med. 2020 Jan 22;2(1):85-93. doi: 10.1016/j.xkme.2020.01.001. eCollection 2020 Jan-Feb.

    PMID: 33015613BACKGROUND
  • Rudnick MR, Leonberg-Yoo AK, Litt HI, Cohen RM, Hilton S, Reese PP. The Controversy of Contrast-Induced Nephropathy With Intravenous Contrast: What Is the Risk? Am J Kidney Dis. 2020 Jan;75(1):105-113. doi: 10.1053/j.ajkd.2019.05.022. Epub 2019 Aug 28.

    PMID: 31473019BACKGROUND

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

  • Chang Yin Chionh, FASN

    Changi General Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2020

First Posted

October 28, 2020

Study Start

May 31, 2023

Primary Completion

June 30, 2025

Study Completion (Estimated)

June 30, 2026

Last Updated

January 3, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations