Trial Outcomes & Findings for Effects of Contrast Media on Subjects With Stable Reduced Renal Function Undergoing Contrast-Enhanced Computed Tomography (NCT NCT00793182)

Results Overview

Contrast-induced nephropathy (CIN) is defined as an increase of ≥ 25% or an increase of ≥ 0.5 mg/dL from baseline serum creatinine (SCr), within 48 - 72 hours after contrast medium administration. For each patient, SCr values were measured from 2 to 24 hours before and from 48 to 72 hours after contrast medium administration.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

6 participants

Primary outcome timeframe

Based on the SCr values of each patient measured from 2 to 24 hours before and from 48 to 72 hours after contrast medium administration

Results posted on

2019-03-06

Participant Flow

A total of 6 patients signed an informed consent for the study and therefore were considered as included

Participant milestones

Participant milestones
Measure	Iodixanol Patients randomized to receive Iodixanol 320 mgI/mL.	Ioversol Patients randomized to receive Ioversol 320 mgI/mL.
Overall Study STARTED	2	4
Overall Study COMPLETED	2	3
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Iodixanol Patients randomized to receive Iodixanol 320 mgI/mL.	Ioversol Patients randomized to receive Ioversol 320 mgI/mL.
Overall Study Adverse Event	0	1

Baseline Characteristics

Effects of Contrast Media on Subjects With Stable Reduced Renal Function Undergoing Contrast-Enhanced Computed Tomography

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	IodixanoI n=2 Participants Patients randomized to receive iodixanol 320 mgI/mL.	IoversoI n=4 Participants Patients randomized to receive ioversol 320 mgI/mL.	Total n=6 Participants Total of all reporting groups
Age, Continuous	69.8 years STANDARD_DEVIATION 7.0 • n=5 Participants	69.8 years STANDARD_DEVIATION 7.0 • n=7 Participants	69.8 years STANDARD_DEVIATION 7.0 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Based on the SCr values of each patient measured from 2 to 24 hours before and from 48 to 72 hours after contrast medium administration

Population: One patient from the Ioversol arm was prematurely withdrawn just after contrast medium administration due to the discovery of a new brain mass. Consequently, no SCr measurement was performed for this patient and the primary outcome could not be analyzed.

Contrast-induced nephropathy (CIN) is defined as an increase of ≥ 25% or an increase of ≥ 0.5 mg/dL from baseline serum creatinine (SCr), within 48 - 72 hours after contrast medium administration. For each patient, SCr values were measured from 2 to 24 hours before and from 48 to 72 hours after contrast medium administration.

Outcome measures

Outcome measures
Measure	Iodixanol n=2 Participants Patients who received iodixanol	IoversoI n=3 Participants Patients who received ioversol
Percentage of Patients With Contrast-induced Nephropathy (CIN)	0 Participants	0 Participants

Adverse Events

Iodixanol

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Ioversol

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Iodixanol n=2 participants at risk Patients who received iodixanol 320 mgI/mL.	Ioversol n=4 participants at risk Patients who received ioversol 320 mgI/mL.
Nervous system disorders Asymptomatic brain mass	0.00% 0/2 • All adverse events occuring during the time from signing of informed consent to the conclusion of the study were recorded. Overall, the study duration ranged from 1 day to 86 days.	25.0% 1/4 • Number of events 1 • All adverse events occuring during the time from signing of informed consent to the conclusion of the study were recorded. Overall, the study duration ranged from 1 day to 86 days.

Other adverse events

Other adverse events
Measure	Iodixanol n=2 participants at risk Patients who received iodixanol 320 mgI/mL.	Ioversol n=4 participants at risk Patients who received ioversol 320 mgI/mL.
Gastrointestinal disorders Diarrhea	50.0% 1/2 • All adverse events occuring during the time from signing of informed consent to the conclusion of the study were recorded. Overall, the study duration ranged from 1 day to 86 days.	0.00% 0/4 • All adverse events occuring during the time from signing of informed consent to the conclusion of the study were recorded. Overall, the study duration ranged from 1 day to 86 days.
Nervous system disorders Headache	50.0% 1/2 • All adverse events occuring during the time from signing of informed consent to the conclusion of the study were recorded. Overall, the study duration ranged from 1 day to 86 days.	0.00% 0/4 • All adverse events occuring during the time from signing of informed consent to the conclusion of the study were recorded. Overall, the study duration ranged from 1 day to 86 days.
Nervous system disorders Dysgeusia	0.00% 0/2 • All adverse events occuring during the time from signing of informed consent to the conclusion of the study were recorded. Overall, the study duration ranged from 1 day to 86 days.	25.0% 1/4 • All adverse events occuring during the time from signing of informed consent to the conclusion of the study were recorded. Overall, the study duration ranged from 1 day to 86 days.

Additional Information

Corinne Dubourdieu, PharmD, Head of Clinical Projects and Medical Writing

Guerbet

Phone: 33 (0) 1 45 91 50 00

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place