Chronic Kidney Disease
Conditions
Keywords
Contrast-associated acute kidney injury, Coronary angiography, Chronic kidney disease, Intravenous hydration
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.
Interventions
OTHERStandard Hydration
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
OTHERSimplified Hydration
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.
Sponsors
Peking University First Hospital
Fudan University
The General Hospital of Northern Theater Command
Xiamen Cardiovascular Hospital, Xiamen University
First Affiliated Hospital of Guangxi Medical University
Sichuan Provincial People's Hospital
Wuhan Asia Heart Hospital
West China Hospital
Jining Medical University
The First Affiliated Hospital of Zhengzhou University
Fujian Provincial Hospital
First Affiliated Hospital, Sun Yat-Sen University
Fuling Central Hospital of Chongqing City
Second Xiangya Hospital of Central South University
People's Hospital of Guangxi Zhuang Autonomous Region
Maoming People's Hospital
Xijing Hospital
Beijing Friendship Hospital
Tangshan Gongren Hospital
Xuzhou Central Hospital
Southern Medical University, China
Guangdong Provincial People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Contrast-associated acute kidney injury a | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Acute heart failure | post-procedural during hospitalization, an average of 3 days | 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) |
| Contrast-associated acute kidney injury b | 72 hours | Defined as ≥0.5 mg/dL increase in serum creatinine from baseline during the first 48-72 hours after the procedure |
| Contrast-associated acute kidney injury c | 24 hours | Defined as ≥10% increase in serum cystatin c from baseline during the first 24 hours after the procedure |
| Contrast-associated acute kidney injury d | 48 hours | Defined as ≥50% or 0.3 mg/dL increase in serum creatinine from baseline during the first 48 hours after the procedure |
| Contrast-associated acute kidney injury e | 24 hours | Defined as ≥0.3mg/dl increase in serum cystatin c from baseline during the first 24 hours after the procedure |
| Change in eGFR a | 72 hours | Change in eGFR within 48-72 hours after procedure (calculated according to the simplified MDRD formula) |
| Change in eGFR b | 72 hours | Change in eGFR within 48-72 hours after procedure (calculated according to the Cysc) |
| Contrast-induced persistence kidney injury | 3 months | 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 |
| Length of stay | an average of 7 days | Total length of hospital stay |
| Total hospitalization costs | an average of 7 days | Hospitalization expenses during hospitalization |
| Major adverse clinical events | 1 year | Including all-cause mortality, renal replacement therapy, nonfatal myocardial infarction, acute pulmonary edema, stroke, rehospitalization, bleeding |
Countries
China
Outcome results
None listed