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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
1,002
Sodium chloride hydration was set between 12 hours before coronary intervention (before contrast exposure during coronary angiography), continued during procedure, and 12 hours after procedure at 1 ml/kg/h (0.5 ml/kg/h For patients with congestive heart failure, New York Heart Association class\>II, or LVEF \< 35%). For patients weighing more than 80 kg, bolus and infusion rates are limited to calculated values for patients weighing 80 kg
Hydration with sodium chloride was set 1 hour before procedure (before contrast exposure during coronary angiography), continued during procedure, and 4 hours after procedure at 3ml/kg/h (1.5ml/kg/h For patients with congestive heart failure, New York Heart Association class\>II, or LVEF \<35%). For patients weighing more than 80 kg, bolus and infusion rates are limited to those calculated for patients weighing 80 kg.
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
Contrast-associated acute kidney injury a
Defined as ≥25% or 0.5 mg/dL absolute increase in serum creatinine from baseline during the first 48-72 hours after the procedure
Time frame: 72 hours
Number of Participants with Acute heart failure
Defined as signs/symptoms of heart congestion and/or hypoperfusion by physical examination and auxiliary examination such as ECG, chest X-ray, laboratory assessment (biomarkers and echocardiography)
Time frame: post-procedural during hospitalization, an average of 3 days
Contrast-associated acute kidney injury b
Defined as ≥0.5 mg/dL increase in serum creatinine from baseline during the first 48-72 hours after the procedure
Time frame: 72 hours
Contrast-associated acute kidney injury c
Defined as ≥10% increase in serum cystatin c from baseline during the first 24 hours after the procedure
Time frame: 24 hours
Contrast-associated acute kidney injury d
Defined as ≥50% or 0.3 mg/dL increase in serum creatinine from baseline during the first 48 hours after the procedure
Time frame: 48 hours
Contrast-associated acute kidney injury e
Defined as ≥0.3mg/dl increase in serum cystatin c from baseline during the first 24 hours after the procedure
Time frame: 24 hours
Major adverse clinical events
Including all-cause mortality, renal replacement therapy, nonfatal myocardial infarction, acute pulmonary edema, stroke, rehospitalization, bleeding
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Time frame: 1 year
Change in eGFR a
Change in eGFR within 48-72 hours after procedure (calculated according to the simplified MDRD formula)
Time frame: 72 hours
Change in eGFR b
Change in eGFR within 48-72 hours after procedure (calculated according to the Cysc)
Time frame: 72 hours
Contrast-induced persistence kidney injury
Defined as residual impairment of renal function indicated by a \>25% reduction in creatinine clearance in comparison with the baseline value or dialysis requirement at 3 months
Time frame: 3 months
Length of stay
Total length of hospital stay
Time frame: an average of 7 days
Total hospitalization costs
Hospitalization expenses during hospitalization
Time frame: an average of 7 days