Comparison of relapse rate of adverse drug reaction according to the type of side chain of CT contrast media

CT Contrast Media SIDE Chain Change for Reduction of Adverse Drug REaction

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0009471

Enrollment

1108

Registered

2024-05-27

Start date

2024-07-14

Completion date

Unknown

Last updated

2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : In patients with a history of prior acute ICM-associated ADRs, participants were randomly assigned to either the different side chain group, in which an ICM with a different N-(2,3-dihydroxypro

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Adults aged 18 years or older who had been admitted to the outpatient clinic 2. Documented history of an acute index ICM-associated ADR with available information on the administered ICM, and the type and severity of the index reaction 3. Clinical indication for receiving a contrast-enhanced CT examination 4. eGFR = 30 mL/min/1.73m²

Exclusion criteria

Exclusion criteria: 1. an acute index ICM-associated ADR classified as anaphylaxis 2. acute index ICM-associated ADRs by both side chain groups, so that a different or common side chain agent could each be defined for random allocation 3. Administration of any ICM within 7 days prior to screening 4. Presence of ICM specifically recommended by an allergist that would conflict with random allocation

Design outcomes

Primary

Measure	Time frame
Recurrence rate of acute contrast agent adverse reaction according to the change in contrast agent type based on the presence or absence of Carbamoyl side chain	—

Secondary

Measure	Time frame
Recurrence rate of delayed contrast agent adverse reaction according to the change in contrast agent type based on the presence or absence of Carbamoyl side chain;Severity distribution of recurrence rate of acute contrast agent adverse reaction according to the change in contrast agent type based on the presence or absence of Carbamoyl side chain;The rate of acute recurrent adverse reaction severity downgrading, defined as the occurrence of a recurrent acute adverse reaction of lesser severity than the prior worst reaction or no recurrence	—

Measure

Time frame

Recurrence rate of delayed contrast agent adverse reaction according to the change in contrast agent type based on the presence or absence of Carbamoyl side chain;Severity distribution of recurrence rate of acute contrast agent adverse reaction according to the change in contrast agent type based on the presence or absence of Carbamoyl side chain;The rate of acute recurrent adverse reaction severity downgrading, defined as the occurrence of a recurrent acute adverse reaction of lesser severity than the prior worst reaction or no recurrence

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Countries

Korea, Republic of

Contacts

Public ContactEunju Park

Asan Medical Center

ketopark@hanmail.net+82-2-3010-6413

Outcome results