The Optimal Hydration With Sodium Chloride in High Risk Patients Undergoing Coronary Angiography, Reduction of Risk of Contrast-associated Acute Kidney Injury After Cardiac Catheterization 2 (TIME RESCIND 2) Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 1,002
- Locations
- 1
- Primary Endpoint
- Contrast-associated acute kidney injury a
Study Overview
Brief Summary
No well-defined protocols exist to guide fluid administration for prevention of contrast-associated acute kidney injury in high risk patients. The investigators will compare long term hydration at routine speed(12h before and after procedure at 1ml/kg/h) with short term hydration at high speed(1h before and 4h after procedure at 3ml/kg/h) to verify our hypothesis that the short term hydration may not be inferior to the long one.
Detailed Description
No well-defined protocols exist to guide fluid administration for prevention of contrast-associated acute kidney injury in high risk patients undergoing coronary angiography. Long term hydration at routine speed(12h before and after procedure at 1ml/kg/h), as the most recommended adequate hydration, has been carried out to prevent contrast-associated acute kidney injury in lots of clinical trials. Base on the data in the POSEIDON randomized controlled trial with hemodynamic-guided fluid administration, short term hydration at high speed(1h before and 4h after procedure at 3ml/kg/h) may not be inferior to the classic long term hydration, the speed should be reduced half of the intended speed in all the patients. We hypothesized short term hydration may not be inferior to the long one to reduced significantly the hospital stay and healthy cost.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •≥18 years of age;
- •Written informed consent;
- •Candidates scheduled for coronary intervention (angiography and/or coronary intervention);
- •Patients with chronic renal insufficiency, the baseline estimated glomerular filtration rate (eGFR) was 15-60 mL/min / 1.73 m²
- •At least one risk factor (age>75 years, medical history of diabetes mellitus or hypertension, congestive heart failure [NYHA class >II or history of acute pulmonary edema]);
Exclusion Criteria
- •End-stage renal failure or heart/renal transplantation;
- •History of exposure to contrast medium or acute infectious diseases within 48 hours prior to the procedure;
- •Acute decompensated heart failure;
- •Left ventricular thrombus;
- •Allergy to contrast agent;
- •Pregnancy or lactation;
- •Malignant tumour or life expectancy <1 year;
- •Pre-procedural receipt of NSAIDs (except Asprin), aminoglycosides, cyclosporine or cisplatin in the past 48 h;
- •Severe valve disease or elective undergoing surgery.
Arms & Interventions
Standard Hydration
Standard long-term hydration, i.e. hydrated with normal saline 12 hours before and 12 hours after coronary intervention at a rate of 1 ml/kg/h
Intervention: Standard Hydration (Other)
Simplified Hydration
Rapid short-term hydration, i.e. hydrated with normal saline from 1 hour before to 4 hours after coronary intervention at a rate of 3 ml/kg/h
Intervention: Simplified Hydration (Other)
Outcomes
Primary Outcomes
Contrast-associated acute kidney injury a
Time Frame: 72 hours
Defined as ≥25% or 0.5 mg/dL absolute increase in serum creatinine from baseline during the first 48-72 hours after the procedure
Secondary Outcomes
- Number of Participants with Acute heart failure(post-procedural during hospitalization, an average of 3 days)
- Major adverse clinical events(1 year)
- Length of stay(an average of 7 days)
- Contrast-associated acute kidney injury b(72 hours)
- Contrast-associated acute kidney injury d(48 hours)
- Contrast-associated acute kidney injury c(24 hours)
- Contrast-associated acute kidney injury e(24 hours)
- Change in eGFR a(72 hours)
- Contrast-induced persistence kidney injury(3 months)
- Change in eGFR b(72 hours)
- Total hospitalization costs(an average of 7 days)
Investigators
Jiyan Chen
MD
Guangdong Provincial People's Hospital