Aortic Aneurysm Clinical Trial
— RIPC-EVAROfficial title:
Effect of Remote Ischemic Preconditioning on the Incidence of Contrast Induced Nephropathy in Patients Undergoing EVAR
Introduction: Contrast induced nephropathy (CIN) is a major inconvenience in the use of iodinated contrast media (ICM) and it is associated with a significant increase in morbimortality and cost of hospitalization. Remote ischemic preconditioning (RIPC) is a non-invasive and cost-effective tissular protection technique that has proven beneficial in decreasing renal insult in patients receiving intravascular contrast. Aim: The primary outcome of this study is to evaluate the impact of RIPC on the incidence of CIN in patients undergoing endovascular aneurysm repair.Material and Methods: Patients suffering from aortic aneurysm were recruited prior to the administration of iodinated contrast media. Randomization was used to assign patients into the control/RIPC groups. Biochemical parameters determined renal function before and after surgery in immediate (24-72 hours) and at 30 days' follow-up.
Status | Completed |
Enrollment | 120 |
Est. completion date | May 20, 2020 |
Est. primary completion date | September 17, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - patients scheduled for elective aortic surgery treated by endovascular repair Exclusion Criteria: - peripheral artery disease in the upper limbs - chronic kidney disease grade V on replacement therapy with haemodialysis, - - patients with cardiac decompensation at the time of the interventio - those who did not tolerate the preparation by ischemic preconditioning in the non-dominant upper limb or who refused to participate in the study. |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Clínico Universitario | Valladolid |
Lead Sponsor | Collaborator |
---|---|
Vascular Investigation Network Spanish Society for Angiology and Vascular Surgery | Hospital Clínico Universitario de Valladolid |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of contrast induces nephropathy in patients udergoing evar | serum creatinine | 48 hours | |
Primary | Incidence of contrast induces nephropathy in patients udergoing evar | serum creatinine | 30 days | |
Primary | Incidence of contrast induces nephropathy in patients udergoing evar | Estimated glomerular filtrate | 48 hours | |
Primary | Incidence of contrast induces nephropathy in patients udergoing evar | Estimated glomerular filtrate | 30 days | |
Secondary | Other variables | urinary albumin:creatinine ratio | 48 hours | |
Secondary | Other variables | Hematocrit levels | 48 hours | |
Secondary | Other variables | urinary albumin:creatinine ratio | 30 days | |
Secondary | Other variables | Hematocrit levels | 30 days |
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