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| ID | Type | Description | Link |
|---|---|---|---|
| CSC20140818 | Other Identifier | Chinese Society of Cardiology |
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| Name | Class |
|---|---|
| Peking University First Hospital | OTHER |
| Fudan University | OTHER |
| The General Hospital of Northern Theater Command | OTHER |
| Xiamen Cardiovascular Hospital, Xiamen University |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Hydration | Active Comparator | 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 |
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| Simplified Hydration | Active Comparator | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Hydration | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | post-procedural during hospitalization, an average of 3 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jiyan Chen, MD | Guangdong Cardiovascular Institute, Guangdong Provincial People's Hospital | Study Chair |
| Yong Liu, MD | Guangdong Cardiovascular Institute, Guangdong Provincial People's Hospital | Study Director |
| Yong Huo, MD | Peking University First Hospital | Principal Investigator |
| Junbo Ge, MD | Fudan University | Principal Investigator |
| Pingyan Chen, MS | Southern Medical University, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong Provincial People's Hospital | Guangzhou | Guangdong | 501080 | China |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| OTHER |
| First Affiliated Hospital of Guangxi Medical University | OTHER |
| Sichuan Provincial People's Hospital | OTHER |
| Wuhan Asia Heart Hospital | OTHER |
| West China Hospital | OTHER |
| Jining Medical University | OTHER |
| The First Affiliated Hospital of Zhengzhou University | OTHER |
| Fujian Provincial Hospital | OTHER |
| First Affiliated Hospital, Sun Yat-Sen University | OTHER |
| Fuling Central Hospital of Chongqing City | OTHER |
| Second Xiangya Hospital of Central South University | OTHER |
| People's Hospital of Guangxi Zhuang Autonomous Region | OTHER |
| Maoming People's Hospital | OTHER |
| Xijing Hospital | OTHER |
| Beijing Friendship Hospital | OTHER |
| Tangshan Gongren Hospital | OTHER |
| Xuzhou Central Hospital | OTHER |
| Southern Medical University, China | OTHER |
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| Simplified Hydration | Other | 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. |
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| 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 |
| 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 | 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 | 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 | 24 hours |
| Major adverse clinical events | Including all-cause mortality, renal replacement therapy, nonfatal myocardial infarction, acute pulmonary edema, stroke, rehospitalization, bleeding | 1 year |
| Change in eGFR a | Change in eGFR within 48-72 hours after procedure (calculated according to the simplified MDRD formula) | 72 hours |
| Change in eGFR b | Change in eGFR within 48-72 hours after procedure (calculated according to the Cysc) | 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 | 3 months |
| Length of stay | Total length of hospital stay | an average of 7 days |
| Total hospitalization costs | Hospitalization expenses during hospitalization | an average of 7 days |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |