Ignite Creation Date:
2024-05-06 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04714736
Status:
COMPLETED
Last Update Posted:
2024-03-05
First Post:
2021-01-10
Brief Title:
DyeVert System and Contrast-induced Acute Kidney Injury
Sponsor:
Clinica Mediterranea
Organization:
Clinica Mediterranea
Study Overview
Official Title:
Renal Insufficiency Following Contrast Media Administration Trial IV Contrast Media Volume Control for Limiting Contrast-Induced Acute Kidney in Acute Coronary Syndrome
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REMEDIALIV
Brief Summary:
The aim of the REnal Insufficiency Following Contrast MEDIA Administration TriaL IV REMEDIAL IV is to test whether the use of the DyeVert system is effective in reducing CI-AKI rate in ACS patients undergoing urgentimmediate within 2 hours invasive diagnostic andor interventional cardiovascular procedures The DyeVert system Osprey Medical Inc Minnetonka MN USA is a novel device designed to reduce CM volume during coronary procedures while maintaining fluoroscopic image quality
Patients with ACS scheduled for urgentimmediate coronary angiographyangioplasty will be enrolled and randomized into 2 groups 1 DyeVert group CM injection will be handled by the DyeVert TM system and 2 Control group CM injection will be carried out by a conventional manual injection syringe
Patients with ACS scheduled for urgentimmediate coronary angiographyangioplasty will be enrolled and randomized into 2 groups 1 DyeVert group CM injection will be handled by the DyeVert TM system and 2 Control group CM injection will be carried out by a conventional manual injection syringe
Detailed Description:
Acute kidney injury AKI is a common complication in patients suffering from acute coronary syndromes ACS and treated by percutaneous coronary intervention PCI This complication has been associated with higher early and late adverse events It has been emphasized that the pathogenesis of AKI in the setting of ACS is multifactorial including age unstable hemodynamic conditions co-morbidities that is diabetes mellitus and anemia pre-existing chronic kidney disease dehydration and administration of nephrotoxic drugs However the role of iodinated contrast media CM has been well established Hydration represents the cornerstone in contrast-induced AKI CI-AKI prevention However at present there is no consensus on how hydration should be carried out especially in ACS patients and all the the recommended hydration regimens have limited applicability in the urgentemergent settings such as ACS Several targeted hydration regimens have been proposed but none has been tested in ACS patients in the present trial the investigators will adopt the left ventricular end diastolic pressure LVEDP -guided hydration because this approach is simple and easy to implement in the current target population The CM volume used is an independent predictor of CI-AKI and the concept that the lower the CM volume the lower the CI-AKI risk is generally accepted The administration of a CM volume 3X glomerular filtration rate GFR is suggestive of increased risk of CI-AKI To date the use of manual injections with a manifold remains the preferred technique in the majority of catheterization laboratories In particular manual injection is often favored for interventional procedures which require low variable-flow pressure injections The AVERT trial demonstrated that CM volume is significantly lower in patients randomized to DyeVert in comparison to control 369 109 mL versus 625 127 mL p 0001 and the observed reduction in CM volume used was most evident in patients undergoing PCI Therefore in this scenario is of outmost importance to limit the CM volume in the attempt to prevent CI-AKI The aim of the REnal Insufficiency Following Contrast MEDIA Administration TriaL IV REMEDIAL IV is to test whether the use of the DyeVert system is effective in reducing CI-AKI rate in ACS patients undergoing urgent or immediate within 2 hours invasive diagnostic andor interventional cardiovascular procedures
METHODS All patients with ACS scheduled for urgentimmediate coronary angiographyangioplasty will be screened for inclusionexclusion criteria Diagnosis of ACS both ST-Elevation Myocardial Infarction STEMI and high-risk Non-ST-Elevation Myocardial Infarction Non-STEMI will be established in accordance with guidelines including a typical chest pain history diagnostic electrocardiographic changes and serial increase of cardiac biomarkers All patients with inclusionexclusion criteria satisfied and who will agree to sign the informed consent will be enrolled into the trial The REMEDIAL IV trial will be conducted at a pool of Italian interventional cardiology centers according to the principles of the Declaration of Helsinki and Good Clinical Practice and has been approved by the local Ethic Committees
All the patients included into the study will receive intravenous 09 sodium chloride as soon as in the catheterization laboratory the hydration regimen will be defined according to the hemodynamic conditions as defined below The patients will be then randomized into 2 groups 1 DyeVert group and 2 Control group
STUDY ENDPOINTS The primary endpoint of the trial is the rate of CI-AKI CI-AKI is defined as an increase in the serum creatinine sCr concentration 03 mgdL from the baseline value within 5 days after CM administration or the need for dialysis Secondary end-points will include 1 differences in the CM volume in the 2 groups 2 an increase in the sCr concentration 25 within 5 days after CM exposure 4 the severity of AKI assessed according to the Acute Kidney Injury Network criteria Stage 1 a sCr increase 03 mgdL or 15-19 times from baseline Stage 2 a sCr increase 20-29 times from baseline and Stage 3 a sCr increase 30 times from baseline or the need for dialysis 5 changes in the serum cystatin C concentration at 24 and 48 hours after CM exposure 6 the rate of acute renal failure requiring dialysis defined as a decrease in renal function necessitating acute hemodialysis ultrafiltration or peritoneal dialysis within the first 5 days post-intervention 7 the rate of in-hospital 6 and 12-month major adverse events MAE including death renal failure requiring dialysis acute pulmonary edema and sustained kidney injury Sustained kidney injury is defined as a persistent 25 GFR reduction compared to baseline at 6 and 12 months and 8 the length in in-hospital stay calculated as the sum of the number of days since admission until discharge from the hospital
METHODS All patients with ACS scheduled for urgentimmediate coronary angiographyangioplasty will be screened for inclusionexclusion criteria Diagnosis of ACS both ST-Elevation Myocardial Infarction STEMI and high-risk Non-ST-Elevation Myocardial Infarction Non-STEMI will be established in accordance with guidelines including a typical chest pain history diagnostic electrocardiographic changes and serial increase of cardiac biomarkers All patients with inclusionexclusion criteria satisfied and who will agree to sign the informed consent will be enrolled into the trial The REMEDIAL IV trial will be conducted at a pool of Italian interventional cardiology centers according to the principles of the Declaration of Helsinki and Good Clinical Practice and has been approved by the local Ethic Committees
All the patients included into the study will receive intravenous 09 sodium chloride as soon as in the catheterization laboratory the hydration regimen will be defined according to the hemodynamic conditions as defined below The patients will be then randomized into 2 groups 1 DyeVert group and 2 Control group
STUDY ENDPOINTS The primary endpoint of the trial is the rate of CI-AKI CI-AKI is defined as an increase in the serum creatinine sCr concentration 03 mgdL from the baseline value within 5 days after CM administration or the need for dialysis Secondary end-points will include 1 differences in the CM volume in the 2 groups 2 an increase in the sCr concentration 25 within 5 days after CM exposure 4 the severity of AKI assessed according to the Acute Kidney Injury Network criteria Stage 1 a sCr increase 03 mgdL or 15-19 times from baseline Stage 2 a sCr increase 20-29 times from baseline and Stage 3 a sCr increase 30 times from baseline or the need for dialysis 5 changes in the serum cystatin C concentration at 24 and 48 hours after CM exposure 6 the rate of acute renal failure requiring dialysis defined as a decrease in renal function necessitating acute hemodialysis ultrafiltration or peritoneal dialysis within the first 5 days post-intervention 7 the rate of in-hospital 6 and 12-month major adverse events MAE including death renal failure requiring dialysis acute pulmonary edema and sustained kidney injury Sustained kidney injury is defined as a persistent 25 GFR reduction compared to baseline at 6 and 12 months and 8 the length in in-hospital stay calculated as the sum of the number of days since admission until discharge from the hospital
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None