Trial Outcomes & Findings for Mechanisms for the Effect of Acetylcysteine on Renal Function After Exposure to Radiographic Contrast Material (NCT NCT00558142)
NCT ID: NCT00558142
Last Updated: 2024-09-19
Results Overview
Measurement of change in renal blood flow through para-aminohippuric acid (PAH) elimination
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
107 participants
Primary outcome timeframe
0, 2, 2.25, 2.5, 4, 6, and 8 hrs
Results posted on
2024-09-19
Participant Flow
Participant milestones
| Measure |
Healthy Volunteers, no Contrast
Healthy volunteers will be randomised to receive either placebo capsules PO plus an infusion of normal saline, acetylcysteine capsules PO plus an infusion of normal saline or placebo capsules PO plus an IV infusion of acetylcysteine in normal saline
Acetylcysteine: Participants will receive packs of either 8 placebo capsules or 8 acetylcysteine (600mg) capsules. They will be asked to take 2 tablets at 08.00 and 22.00 on the day before the study and the day of the study. On the day of the study participants will receive an IV infusion of either normal saline or acetylcysteine (200mg/kg)
|
CKDIII Patients, no Contrast
Volunteers with CKD III will be randomised to receive either placebo capsules PO plus an infusion of normal saline, acetylcysteine capsules PO plus an infusion of normal saline or placebo capsules PO plus an IV infusion of acetylcysteine in normal saline
Acetylcysteine: Participants will receive packs of either 8 placebo capsules or 8 acetylcysteine (600mg) capsules. They will be asked to take 2 tablets at 08.00 and 22.00 on the day before the study and the day of the study. On the day of the study participants will receive an IV infusion of either normal saline or acetylcysteine (200mg/kg)
|
Healthy Volunteers, With Contrast
Healthy volunteers will receive a single IV dose of 100mls Visipaque 320 (iodixanol, equivalent to 320 mg iodine/ml). They will then be randomised to receive either placebo capsules PO plus an infusion of normal saline, acetylcysteine capsules PO plus an infusion of normal saline or placebo capsules PO plus an IV infusion of acetylcysteine in normal saline
Acetylcysteine: Participants will receive packs of either 8 placebo capsules or 8 acetylcysteine (600mg) capsules. They will be asked to take 2 tablets at 08.00 and 22.00 on the day before the study and the day of the study. On the day of the study participants will receive an IV infusion of either normal saline or acetylcysteine (200mg/kg)
Visipaque 320: 100mls IV dose as single dose
|
CKD III Patients, With Contrast
Volunteers with CKD III will receive Visipaque 320 during coronary angiography. They will have been randomised to receive either placebo capsules PO plus an infusion of normal saline, acetylcysteine capsules PO plus an infusion of normal saline or placebo capsules PO plus an IV infusion of acetylcysteine in normal saline
Acetylcysteine: Participants will receive packs of either 8 placebo capsules or 8 acetylcysteine (600mg) capsules. They will be asked to take 2 tablets at 08.00 and 22.00 on the day before the study and the day of the study. On the day of the study participants will receive an IV infusion of either normal saline or acetylcysteine (200mg/kg)
Visipaque 320: The dose of Visipaque will be administered by the consultant cardiologist performing the coronary angiography
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
13
|
8
|
76
|
|
Overall Study
COMPLETED
|
8
|
8
|
8
|
66
|
|
Overall Study
NOT COMPLETED
|
2
|
5
|
0
|
10
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Mechanisms for the Effect of Acetylcysteine on Renal Function After Exposure to Radiographic Contrast Material
Baseline characteristics by cohort
| Measure |
Healthy Volunteers, no Contrast
n=8 Participants
Healthy volunteers will be randomised to receive either placebo capsules PO plus an infusion of normal saline, acetylcysteine capsules PO plus an infusion of normal saline or placebo capsules PO plus an IV infusion of acetylcysteine in normal saline
Acetylcysteine: Participants will receive packs of either 8 placebo capsules or 8 acetylcysteine (600mg) capsules. They will be asked to take 2 tablets at 08.00 and 22.00 on the day before the study and the day of the study. On the day of the study participants will receive an IV infusion of either normal saline or acetylcysteine (200mg/kg)
|
CKD III Patients, no Contrast
n=8 Participants
Volunteers with CKD III will be randomised to receive either placebo capsules PO plus an infusion of normal saline, acetylcysteine capsules PO plus an infusion of normal saline or placebo capsules PO plus an IV infusion of acetylcysteine in normal saline
Acetylcysteine: Participants will receive packs of either 8 placebo capsules or 8 acetylcysteine (600mg) capsules. They will be asked to take 2 tablets at 08.00 and 22.00 on the day before the study and the day of the study. On the day of the study participants will receive an IV infusion of either normal saline or acetylcysteine (200mg/kg)
|
Healthy Volunteers, With Contrast
n=8 Participants
Healthy volunteers will receive a single IV dose of 100mls Visipaque 320 (iodixanol, equivalent to 320 mg iodine/ml). They will then be randomised to receive either placebo capsules PO plus an infusion of normal saline, acetylcysteine capsules PO plus an infusion of normal saline or placebo capsules PO plus an IV infusion of acetylcysteine in normal saline
Acetylcysteine: Participants will receive packs of either 8 placebo capsules or 8 acetylcysteine (600mg) capsules. They will be asked to take 2 tablets at 08.00 and 22.00 on the day before the study and the day of the study. On the day of the study participants will receive an IV infusion of either normal saline or acetylcysteine (200mg/kg)
Visipaque 320: 100mls IV dose as single dose
|
CKD III Patients, With Contrast
n=66 Participants
Volunteers with CKD III will receive Visipaque 320 during coronary angiography. They will have been randomised to receive either placebo capsules PO plus an infusion of normal saline, acetylcysteine capsules PO plus an infusion of normal saline or placebo capsules PO plus an IV infusion of acetylcysteine in normal saline
Acetylcysteine: Participants will receive packs of either 8 placebo capsules or 8 acetylcysteine (600mg) capsules. They will be asked to take 2 tablets at 08.00 and 22.00 on the day before the study and the day of the study. On the day of the study participants will receive an IV infusion of either normal saline or acetylcysteine (200mg/kg)
Visipaque 320: The dose of Visipaque will be administered by the consultant cardiologist performing the coronary angiography
|
Total
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
59 Participants
n=4 Participants
|
74 Participants
n=21 Participants
|
|
Age, Continuous
|
59 years
STANDARD_DEVIATION 2 • n=5 Participants
|
57 years
STANDARD_DEVIATION 3 • n=7 Participants
|
57 years
STANDARD_DEVIATION 3 • n=5 Participants
|
73 years
STANDARD_DEVIATION 6 • n=4 Participants
|
69 years
STANDARD_DEVIATION 5 • n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
66 Participants
n=4 Participants
|
90 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
65 Participants
n=4 Participants
|
89 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United Kingdom
|
8 participants
n=5 Participants
|
8 participants
n=7 Participants
|
8 participants
n=5 Participants
|
66 participants
n=4 Participants
|
90 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 0, 2, 2.25, 2.5, 4, 6, and 8 hrsMeasurement of change in renal blood flow through para-aminohippuric acid (PAH) elimination
Outcome measures
| Measure |
Healthy Volunteers, no Contrast
n=8 Participants
Healthy volunteers will be randomised to receive either placebo capsules PO plus an infusion of normal saline, acetylcysteine capsules PO plus an infusion of normal saline or placebo capsules PO plus an IV infusion of acetylcysteine in normal saline
Acetylcysteine: Participants will receive packs of either 8 placebo capsules or 8 acetylcysteine (600mg) capsules. They will be asked to take 2 tablets at 08.00 and 22.00 on the day before the study and the day of the study. On the day of the study participants will receive an IV infusion of either normal saline or acetylcysteine (200mg/kg)
|
Volunteers With CKD III, no Contrast
n=8 Participants
Volunteers with CKD III will be randomised to receive either placebo capsules PO plus an infusion of normal saline, acetylcysteine capsules PO plus an infusion of normal saline or placebo capsules PO plus an IV infusion of acetylcysteine in normal saline
Acetylcysteine: Participants will receive packs of either 8 placebo capsules or 8 acetylcysteine (600mg) capsules. They will be asked to take 2 tablets at 08.00 and 22.00 on the day before the study and the day of the study. On the day of the study participants will receive an IV infusion of either normal saline or acetylcysteine (200mg/kg)
|
Healthy Volunteers With Contrast
n=8 Participants
Healthy volunteers will receive a single IV dose of 100mls Visipaque 320 (iodixanol, equivalent to 320 mg iodine/ml). They will then be randomised to receive either placebo capsules PO plus an infusion of normal saline, acetylcysteine capsules PO plus an infusion of normal saline or placebo capsules PO plus an IV infusion of acetylcysteine in normal saline
Acetylcysteine: Participants will receive packs of either 8 placebo capsules or 8 acetylcysteine (600mg) capsules. They will be asked to take 2 tablets at 08.00 and 22.00 on the day before the study and the day of the study. On the day of the study participants will receive an IV infusion of either normal saline or acetylcysteine (200mg/kg)
Visipaque 320: 100mls IV dose as single dose
|
Volunteers With CKD III, With Contrast
n=66 Participants
Patients with CKD III will receive Visipaque 320 during coronary angiography. They will have been randomised to receive either placebo capsules PO plus an infusion of normal saline, acetylcysteine capsules PO plus an infusion of normal saline or placebo capsules PO plus an IV infusion of acetylcysteine in normal saline
Acetylcysteine: Participants will receive packs of either 8 placebo capsules or 8 acetylcysteine (600mg) capsules. They will be asked to take 2 tablets at 08.00 and 22.00 on the day before the study and the day of the study. On the day of the study participants will receive an IV infusion of either normal saline or acetylcysteine (200mg/kg)
Visipaque 320: The dose of Visipaque will be administered by the consultant cardiologist performing the coronary angiography
|
|---|---|---|---|---|
|
Changes in Renal Blood Flow
IV NAC
|
9590.8 h.mL/min
Interval 9168.4 to 10013.2
|
5105.4 h.mL/min
Interval 4714.0 to 5496.9
|
8529.4 h.mL/min
Interval 8096.7 to 8962.1
|
5228.4 h.mL/min
Interval 4935.4 to 5521.3
|
|
Changes in Renal Blood Flow
PO NAC
|
9088.6 h.mL/min
Interval 8668.6 to 9508.6
|
4909.3 h.mL/min
Interval 4517.8 to 5300.7
|
7648.2 h.mL/min
Interval 7213.3 to 8083.2
|
5038.9 h.mL/min
Interval 4740.0 to 5337.9
|
|
Changes in Renal Blood Flow
No NAC, placebo
|
8876.5 h.mL/min
Interval 8452.5 to 9300.5
|
4817.3 h.mL/min
Interval 4426.0 to 5208.5
|
7612.8 h.mL/min
Interval 7185.1 to 8040.6
|
5077.8 h.mL/min
Interval 4785.8 to 5369.8
|
SECONDARY outcome
Timeframe: 0, 2, 2.25, 2.5, 4, 6, and 8 hrsPopulation: Difference between AUCs for IV NAC and placebo
Measurement of change in AUC for glomerular filtration rate through inulin elimination
Outcome measures
| Measure |
Healthy Volunteers, no Contrast
n=8 Participants
Healthy volunteers will be randomised to receive either placebo capsules PO plus an infusion of normal saline, acetylcysteine capsules PO plus an infusion of normal saline or placebo capsules PO plus an IV infusion of acetylcysteine in normal saline
Acetylcysteine: Participants will receive packs of either 8 placebo capsules or 8 acetylcysteine (600mg) capsules. They will be asked to take 2 tablets at 08.00 and 22.00 on the day before the study and the day of the study. On the day of the study participants will receive an IV infusion of either normal saline or acetylcysteine (200mg/kg)
|
Volunteers With CKD III, no Contrast
n=8 Participants
Volunteers with CKD III will be randomised to receive either placebo capsules PO plus an infusion of normal saline, acetylcysteine capsules PO plus an infusion of normal saline or placebo capsules PO plus an IV infusion of acetylcysteine in normal saline
Acetylcysteine: Participants will receive packs of either 8 placebo capsules or 8 acetylcysteine (600mg) capsules. They will be asked to take 2 tablets at 08.00 and 22.00 on the day before the study and the day of the study. On the day of the study participants will receive an IV infusion of either normal saline or acetylcysteine (200mg/kg)
|
Healthy Volunteers With Contrast
n=8 Participants
Healthy volunteers will receive a single IV dose of 100mls Visipaque 320 (iodixanol, equivalent to 320 mg iodine/ml). They will then be randomised to receive either placebo capsules PO plus an infusion of normal saline, acetylcysteine capsules PO plus an infusion of normal saline or placebo capsules PO plus an IV infusion of acetylcysteine in normal saline
Acetylcysteine: Participants will receive packs of either 8 placebo capsules or 8 acetylcysteine (600mg) capsules. They will be asked to take 2 tablets at 08.00 and 22.00 on the day before the study and the day of the study. On the day of the study participants will receive an IV infusion of either normal saline or acetylcysteine (200mg/kg)
Visipaque 320: 100mls IV dose as single dose
|
Volunteers With CKD III, With Contrast
n=65 Participants
Patients with CKD III will receive Visipaque 320 during coronary angiography. They will have been randomised to receive either placebo capsules PO plus an infusion of normal saline, acetylcysteine capsules PO plus an infusion of normal saline or placebo capsules PO plus an IV infusion of acetylcysteine in normal saline
Acetylcysteine: Participants will receive packs of either 8 placebo capsules or 8 acetylcysteine (600mg) capsules. They will be asked to take 2 tablets at 08.00 and 22.00 on the day before the study and the day of the study. On the day of the study participants will receive an IV infusion of either normal saline or acetylcysteine (200mg/kg)
Visipaque 320: The dose of Visipaque will be administered by the consultant cardiologist performing the coronary angiography
|
|---|---|---|---|---|
|
Changes in Glomerular Filtration Rate
|
29.3 h*mL/ min/1.73 m²
Interval -27.8 to 86.4
|
5.9 h*mL/ min/1.73 m²
Interval -30.8 to 42.6
|
146.8 h*mL/ min/1.73 m²
Interval 77.1 to 216.5
|
28.7 h*mL/ min/1.73 m²
Interval -7.9 to 65.3
|
Adverse Events
Healthy Volunteers, no Contrast
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Volunteers With CKD III, no Contrast
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Healthy Volunteers, With Contrast
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Patients With CKD III, With Contrast
Serious events: 6 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Healthy Volunteers, no Contrast
n=8 participants at risk
Healthy volunteers will be randomised to receive either placebo capsules PO plus an infusion of normal saline, acetylcysteine capsules PO plus an infusion of normal saline or placebo capsules PO plus an IV infusion of acetylcysteine in normal saline
Acetylcysteine: Participants will receive packs of either 8 placebo capsules or 8 acetylcysteine (600mg) capsules. They will be asked to take 2 tablets at 08.00 and 22.00 on the day before the study and the day of the study. On the day of the study participants will receive an IV infusion of either normal saline or acetylcysteine (200mg/kg)
|
Volunteers With CKD III, no Contrast
n=8 participants at risk
Volunteers with CKD III will be randomised to receive either placebo capsules PO plus an infusion of normal saline, acetylcysteine capsules PO plus an infusion of normal saline or placebo capsules PO plus an IV infusion of acetylcysteine in normal saline
Acetylcysteine: Participants will receive packs of either 8 placebo capsules or 8 acetylcysteine (600mg) capsules. They will be asked to take 2 tablets at 08.00 and 22.00 on the day before the study and the day of the study. On the day of the study participants will receive an IV infusion of either normal saline or acetylcysteine (200mg/kg)
|
Healthy Volunteers, With Contrast
n=8 participants at risk
Healthy volunteers will receive a single IV dose of 100mls Visipaque 320 (iodixanol, equivalent to 320 mg iodine/ml). They will then be randomised to receive either placebo capsules PO plus an infusion of normal saline, acetylcysteine capsules PO plus an infusion of normal saline or placebo capsules PO plus an IV infusion of acetylcysteine in normal saline
Acetylcysteine: Participants will receive packs of either 8 placebo capsules or 8 acetylcysteine (600mg) capsules. They will be asked to take 2 tablets at 08.00 and 22.00 on the day before the study and the day of the study. On the day of the study participants will receive an IV infusion of either normal saline or acetylcysteine (200mg/kg)
Visipaque 320: 100mls IV dose as single dose
|
Patients With CKD III, With Contrast
n=66 participants at risk
Patients with CKD III will receive Visipaque 320 during coronary angiography. They will have been randomised to receive either placebo capsules PO plus an infusion of normal saline, acetylcysteine capsules PO plus an infusion of normal saline or placebo capsules PO plus an IV infusion of acetylcysteine in normal saline
Acetylcysteine: Participants will receive packs of either 8 placebo capsules or 8 acetylcysteine (600mg) capsules. They will be asked to take 2 tablets at 08.00 and 22.00 on the day before the study and the day of the study. On the day of the study participants will receive an IV infusion of either normal saline or acetylcysteine (200mg/kg)
Visipaque 320: The dose of Visipaque will be administered by the consultant cardiologist performing the coronary angiography
|
|---|---|---|---|---|
|
Cardiac disorders
Chest pain
|
0.00%
0/8
Adverse events are collected per study (4 reported here - 3 cross-over, 1 parallel group study). Adverse events are reported as per study
|
0.00%
0/8
Adverse events are collected per study (4 reported here - 3 cross-over, 1 parallel group study). Adverse events are reported as per study
|
0.00%
0/8
Adverse events are collected per study (4 reported here - 3 cross-over, 1 parallel group study). Adverse events are reported as per study
|
4.5%
3/66 • Number of events 3
Adverse events are collected per study (4 reported here - 3 cross-over, 1 parallel group study). Adverse events are reported as per study
|
|
Cardiac disorders
Exacerbation of heart failure
|
0.00%
0/8
Adverse events are collected per study (4 reported here - 3 cross-over, 1 parallel group study). Adverse events are reported as per study
|
0.00%
0/8
Adverse events are collected per study (4 reported here - 3 cross-over, 1 parallel group study). Adverse events are reported as per study
|
0.00%
0/8
Adverse events are collected per study (4 reported here - 3 cross-over, 1 parallel group study). Adverse events are reported as per study
|
1.5%
1/66 • Number of events 1
Adverse events are collected per study (4 reported here - 3 cross-over, 1 parallel group study). Adverse events are reported as per study
|
|
Cardiac disorders
2nd degree heart block
|
0.00%
0/8
Adverse events are collected per study (4 reported here - 3 cross-over, 1 parallel group study). Adverse events are reported as per study
|
0.00%
0/8
Adverse events are collected per study (4 reported here - 3 cross-over, 1 parallel group study). Adverse events are reported as per study
|
0.00%
0/8
Adverse events are collected per study (4 reported here - 3 cross-over, 1 parallel group study). Adverse events are reported as per study
|
1.5%
1/66 • Number of events 1
Adverse events are collected per study (4 reported here - 3 cross-over, 1 parallel group study). Adverse events are reported as per study
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/8
Adverse events are collected per study (4 reported here - 3 cross-over, 1 parallel group study). Adverse events are reported as per study
|
0.00%
0/8
Adverse events are collected per study (4 reported here - 3 cross-over, 1 parallel group study). Adverse events are reported as per study
|
0.00%
0/8
Adverse events are collected per study (4 reported here - 3 cross-over, 1 parallel group study). Adverse events are reported as per study
|
1.5%
1/66 • Number of events 1
Adverse events are collected per study (4 reported here - 3 cross-over, 1 parallel group study). Adverse events are reported as per study
|
Other adverse events
| Measure |
Healthy Volunteers, no Contrast
n=8 participants at risk
Healthy volunteers will be randomised to receive either placebo capsules PO plus an infusion of normal saline, acetylcysteine capsules PO plus an infusion of normal saline or placebo capsules PO plus an IV infusion of acetylcysteine in normal saline
Acetylcysteine: Participants will receive packs of either 8 placebo capsules or 8 acetylcysteine (600mg) capsules. They will be asked to take 2 tablets at 08.00 and 22.00 on the day before the study and the day of the study. On the day of the study participants will receive an IV infusion of either normal saline or acetylcysteine (200mg/kg)
|
Volunteers With CKD III, no Contrast
n=8 participants at risk
Volunteers with CKD III will be randomised to receive either placebo capsules PO plus an infusion of normal saline, acetylcysteine capsules PO plus an infusion of normal saline or placebo capsules PO plus an IV infusion of acetylcysteine in normal saline
Acetylcysteine: Participants will receive packs of either 8 placebo capsules or 8 acetylcysteine (600mg) capsules. They will be asked to take 2 tablets at 08.00 and 22.00 on the day before the study and the day of the study. On the day of the study participants will receive an IV infusion of either normal saline or acetylcysteine (200mg/kg)
|
Healthy Volunteers, With Contrast
n=8 participants at risk
Healthy volunteers will receive a single IV dose of 100mls Visipaque 320 (iodixanol, equivalent to 320 mg iodine/ml). They will then be randomised to receive either placebo capsules PO plus an infusion of normal saline, acetylcysteine capsules PO plus an infusion of normal saline or placebo capsules PO plus an IV infusion of acetylcysteine in normal saline
Acetylcysteine: Participants will receive packs of either 8 placebo capsules or 8 acetylcysteine (600mg) capsules. They will be asked to take 2 tablets at 08.00 and 22.00 on the day before the study and the day of the study. On the day of the study participants will receive an IV infusion of either normal saline or acetylcysteine (200mg/kg)
Visipaque 320: 100mls IV dose as single dose
|
Patients With CKD III, With Contrast
n=66 participants at risk
Patients with CKD III will receive Visipaque 320 during coronary angiography. They will have been randomised to receive either placebo capsules PO plus an infusion of normal saline, acetylcysteine capsules PO plus an infusion of normal saline or placebo capsules PO plus an IV infusion of acetylcysteine in normal saline
Acetylcysteine: Participants will receive packs of either 8 placebo capsules or 8 acetylcysteine (600mg) capsules. They will be asked to take 2 tablets at 08.00 and 22.00 on the day before the study and the day of the study. On the day of the study participants will receive an IV infusion of either normal saline or acetylcysteine (200mg/kg)
Visipaque 320: The dose of Visipaque will be administered by the consultant cardiologist performing the coronary angiography
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Vomited
|
0.00%
0/8
Adverse events are collected per study (4 reported here - 3 cross-over, 1 parallel group study). Adverse events are reported as per study
|
0.00%
0/8
Adverse events are collected per study (4 reported here - 3 cross-over, 1 parallel group study). Adverse events are reported as per study
|
0.00%
0/8
Adverse events are collected per study (4 reported here - 3 cross-over, 1 parallel group study). Adverse events are reported as per study
|
1.5%
1/66 • Number of events 1
Adverse events are collected per study (4 reported here - 3 cross-over, 1 parallel group study). Adverse events are reported as per study
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/8
Adverse events are collected per study (4 reported here - 3 cross-over, 1 parallel group study). Adverse events are reported as per study
|
0.00%
0/8
Adverse events are collected per study (4 reported here - 3 cross-over, 1 parallel group study). Adverse events are reported as per study
|
0.00%
0/8
Adverse events are collected per study (4 reported here - 3 cross-over, 1 parallel group study). Adverse events are reported as per study
|
1.5%
1/66 • Number of events 1
Adverse events are collected per study (4 reported here - 3 cross-over, 1 parallel group study). Adverse events are reported as per study
|
|
Cardiac disorders
Vasovagal
|
0.00%
0/8
Adverse events are collected per study (4 reported here - 3 cross-over, 1 parallel group study). Adverse events are reported as per study
|
0.00%
0/8
Adverse events are collected per study (4 reported here - 3 cross-over, 1 parallel group study). Adverse events are reported as per study
|
0.00%
0/8
Adverse events are collected per study (4 reported here - 3 cross-over, 1 parallel group study). Adverse events are reported as per study
|
7.6%
5/66 • Number of events 5
Adverse events are collected per study (4 reported here - 3 cross-over, 1 parallel group study). Adverse events are reported as per study
|
|
Nervous system disorders
Headache
|
0.00%
0/8
Adverse events are collected per study (4 reported here - 3 cross-over, 1 parallel group study). Adverse events are reported as per study
|
0.00%
0/8
Adverse events are collected per study (4 reported here - 3 cross-over, 1 parallel group study). Adverse events are reported as per study
|
0.00%
0/8
Adverse events are collected per study (4 reported here - 3 cross-over, 1 parallel group study). Adverse events are reported as per study
|
1.5%
1/66 • Number of events 1
Adverse events are collected per study (4 reported here - 3 cross-over, 1 parallel group study). Adverse events are reported as per study
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/8
Adverse events are collected per study (4 reported here - 3 cross-over, 1 parallel group study). Adverse events are reported as per study
|
0.00%
0/8
Adverse events are collected per study (4 reported here - 3 cross-over, 1 parallel group study). Adverse events are reported as per study
|
0.00%
0/8
Adverse events are collected per study (4 reported here - 3 cross-over, 1 parallel group study). Adverse events are reported as per study
|
3.0%
2/66 • Number of events 2
Adverse events are collected per study (4 reported here - 3 cross-over, 1 parallel group study). Adverse events are reported as per study
|
|
Cardiac disorders
Chest pain
|
0.00%
0/8
Adverse events are collected per study (4 reported here - 3 cross-over, 1 parallel group study). Adverse events are reported as per study
|
0.00%
0/8
Adverse events are collected per study (4 reported here - 3 cross-over, 1 parallel group study). Adverse events are reported as per study
|
0.00%
0/8
Adverse events are collected per study (4 reported here - 3 cross-over, 1 parallel group study). Adverse events are reported as per study
|
1.5%
1/66 • Number of events 1
Adverse events are collected per study (4 reported here - 3 cross-over, 1 parallel group study). Adverse events are reported as per study
|
|
Cardiac disorders
Bleeding from radial catheter site
|
0.00%
0/8
Adverse events are collected per study (4 reported here - 3 cross-over, 1 parallel group study). Adverse events are reported as per study
|
0.00%
0/8
Adverse events are collected per study (4 reported here - 3 cross-over, 1 parallel group study). Adverse events are reported as per study
|
0.00%
0/8
Adverse events are collected per study (4 reported here - 3 cross-over, 1 parallel group study). Adverse events are reported as per study
|
1.5%
1/66 • Number of events 1
Adverse events are collected per study (4 reported here - 3 cross-over, 1 parallel group study). Adverse events are reported as per study
|
|
Cardiac disorders
Ischaemic ECG changes post-Angio
|
0.00%
0/8
Adverse events are collected per study (4 reported here - 3 cross-over, 1 parallel group study). Adverse events are reported as per study
|
0.00%
0/8
Adverse events are collected per study (4 reported here - 3 cross-over, 1 parallel group study). Adverse events are reported as per study
|
0.00%
0/8
Adverse events are collected per study (4 reported here - 3 cross-over, 1 parallel group study). Adverse events are reported as per study
|
1.5%
1/66 • Number of events 1
Adverse events are collected per study (4 reported here - 3 cross-over, 1 parallel group study). Adverse events are reported as per study
|
|
Cardiac disorders
Short self-terminating run of VT
|
0.00%
0/8
Adverse events are collected per study (4 reported here - 3 cross-over, 1 parallel group study). Adverse events are reported as per study
|
0.00%
0/8
Adverse events are collected per study (4 reported here - 3 cross-over, 1 parallel group study). Adverse events are reported as per study
|
0.00%
0/8
Adverse events are collected per study (4 reported here - 3 cross-over, 1 parallel group study). Adverse events are reported as per study
|
1.5%
1/66 • Number of events 1
Adverse events are collected per study (4 reported here - 3 cross-over, 1 parallel group study). Adverse events are reported as per study
|
|
Cardiac disorders
Hypotension
|
0.00%
0/8
Adverse events are collected per study (4 reported here - 3 cross-over, 1 parallel group study). Adverse events are reported as per study
|
0.00%
0/8
Adverse events are collected per study (4 reported here - 3 cross-over, 1 parallel group study). Adverse events are reported as per study
|
0.00%
0/8
Adverse events are collected per study (4 reported here - 3 cross-over, 1 parallel group study). Adverse events are reported as per study
|
1.5%
1/66 • Number of events 1
Adverse events are collected per study (4 reported here - 3 cross-over, 1 parallel group study). Adverse events are reported as per study
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place