Simplified Rapid Hydration in Preventing CA-AKI Among Patients With Chronic Kidney Disease

Study Overview
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Brief Summary
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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.

Detailed Description
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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 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.

Official Title
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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

Conditions
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Chronic Kidney Disease

Intervention / Treatment
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* Other: Standard Hydration
* Other: Simplified Hydration


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Hydration<br>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 | Other: Standard Hydration<br>* 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<br>* Other names: The control hydration group;|
| Active Comparator: Simplified Hydration<br>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 | Other: Simplified Hydration<br>* 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.<br>* Other names: The simple hydration group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Contrast-associated acute kidney injury, Coronary angiography, Chronic kidney disease, Intravenous hydration