Effect of Visipaque on kidney function in adults with CKD after EVAR
Research type
Research Study
Full title
Parallel-Group, Placebo-Controlled, Randomized Study Investigating the Effect of Intravenous Iso-osmolar Iodinated Contrast Material Iodixanol (Visipaque™ Injection 320mgI/mL) on Renal Function in Adults with Chronic Kidney Disease (CKD) Stage III or Stage IV who have undergone Endovascular Aneurysm Repair (EVAR).
IRAS ID
225166
Contact name
Ian Loftus
Contact email
Sponsor organisation
GE Healthcare Ltd. and its Affiliates
Eudract number
2016-001668-13
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 5 months, 9 days
Research summary
Patients in this study have chronic kidney disease (CKD) and have also suffered an aneurysm of the abdominal aorta, the large blood vessel that carries blood to the lower body. Aneurysms are large bulges in blood vessels caused by weaknesses in the vessel’s wall. These can rupture so need to be repaired by a procedure called an endovascular aneurysm repair (EVAR). A CT scan, with contrast dye to help see the images better is done periodically after repair to ensure no further problems. Sometimes this dye can damage the kidneys. People with underlying CKD may be more susceptible to damage from contrast dye. So patients with CKD do not receive contrast dye when undergoing CT scans, even when needed to get the best pictures to diagnose new disease or monitor previous procedures (such as EVAR). Therefore, patients may get an inappropriate/inferior test than the one really needed.
This study uses contrast dye, called Visipaque, to see if it increases risks of developing kidney damage in patients with underlying CKD. Current data is not yet conclusive.
As there has not been enough research to tell doctors whether the dye causes kidney injury, participants will be divided into two groups for comparison. One group will receive Visipaque; the other will receive a substance with no active ingredient (placebo, or simple saline). Participants cannot choose to receive Visipaque or placebo but will be randomly assigned to one of the groups (like flipping a coin). Since so few trials have been conducted to see whether kidney damage can be associated with contrast dyes, the risks/benefits of using contrast in this population are not established. The information collected from this study may enable doctors to make better decisions about whether to use contrast dyes and might improve the future diagnosis/treatment of people with CKD.REC name
London - Fulham Research Ethics Committee
REC reference
18/LO/0012
Date of REC Opinion
8 Mar 2018
REC opinion
Further Information Favourable Opinion