Effect of Hydration Guided by Vigileo on the Prevention of CIN After PCI for Patients With AMI

Study Overview
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Brief Summary
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In this study, Vigileo is used to guide hydration adjustment, and SCr is used to estimate renal function. The aim of the study is to investigate the preventive effect of adequate hydration guided by Vigileo on contrast induced nephropathy in patients with acute myocardial infarction who undergo PCI.

Detailed Description
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This study was conducted in patients with acute myocardial infarction who undergo emergency PCI in Chinese PLA General Hospital. The patients were randomly divided into two groups: the adequate hydration group guided by Vigileo and control group. For the adequate hydration group guided by Vigileo, Vigileo equipment is used to perform hemodynamic monitoring through the femoral or radial arteries to obtain relevant hemodynamic parameters (CO, SV, SVV), and the fluid-rehydration velocity of normal saline is adjusted according to the hemodynamic parameters, and the hydration also lasts 24 hours after operation. For the control group, the routine hydration regimen is adopted, perioperative saline ≤500 ml hydration. The changes of renal function (serum creatinine, serum cystatin), symptoms and signs of cardiac insufficiency during perioperative period and cardiac objective indexes are observed. The incidence of postoperative acute pulmonary edema is recorded, and the major cardiovascular events and hemodialysis events are followed up for 6 months. By comparing the perioperative indexes of heart and kidney function between the intervention group and the control group, the preventive effect of adequate hydration guided by Vigileo on contrast induced nephropathy after PCI was clarified.

Official Title
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Effect of Hydration Guided by Vigileo on the Prevention of Contrast Induced Nephropathy After Emergency PCI for Patients With Acute Myocardial Infarction

Conditions
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Myocardial Infarction, Contrast-induced Nephropathy

Intervention / Treatment
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* Procedure: the adequate hydration group guided by Vigileo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clearly diagnosed STEMI or NSTEMI patients: Patients aged 18-80 years Patients are scheduled to undergo emergency percutaneous coronary interventions Estimated glomerular filtration rate eGFR <120ml / min (according to MDRD formula) Sign the informed consent to join the group. Exclusion Criteria: Patients with mechanical complications Patients with cardiogenic shock Patients with aortic dissection Patients who have malignant tumors or short-term progressive diseases that researchers believe improper to be included in the group Hemodialysis-dependent patients with end-stage renal failure Patients who had a history of exposure to radioactive contrast media within 1 week before or 72 hours after direct PCI Patients who are allergic to radioactive contrast agents Patients diagnosed with right ventricular myocardial infarction with hypotension (defined as systolic blood pressure ≤90 mmHg) on admission.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: the adequate hydration group guided by Vigileo<br>The hydration speed is adjusted according to SVV or SV by Vigileo | Procedure: the adequate hydration group guided by Vigileo<br>* If the patient is mechanically ventilated, the following scheme is adopted: if SVV≤10%, then adjust the rehydration speed to 1 ml/kg/h; if 10%<SVV<15%, then adjust the rehydration speed to 2 ml/kg/h; if SVV≥15%, then adjust the rehydration speed to 3 ml/kg/h. The hydration lasts 24 hours after operation, and the rehydration speed is changed according to the SVV. If the patient does not use mechanical ventilation, the following scheme is adopted: 250ml normal saline is administered within 10 minutes after direct PCI, and the rehydration volume changes to 125ml in patients with mild-to-moderate congestive heart failure. If the increment of SV≥15%, then adjust the rehydration speed to 3 ml/kg/h; if 10%≤the increment of SV<15%, then adjust the rehydration speed to 2 ml/kg/h; if the increment of SV<10%, then adjust the rehydration speed to 1 ml/kg/h. Reassessed every 1 hour until SV is stable，and the hydration also lasts 24 hours after operation.<br>|
| No Intervention: the control group<br>The routine hydration regimen is adopted, perioperative saline ≤500 ml hydration | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Contrast induced nephropathy | Contrast induced nephropathy is defined as serum creatinine values increased by 0.5 mg/dl or 25% relative to baseline absolute values after direct PCI within 48-72 hours. | 48-72 hours after PCI | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The acute renal injury caused by contrast agent | The acute renal injury caused by contrast agent is defined as the serum creatinine value increased by 0.3 mg/dl than the baseline absolute value after direct PCI within 48 hours. | 48 hours after PCI | 
| Persistent renal insufficiency | Persistent renal insufficiency is defined as at least 25% decrease compared with baseline in creatinine clearance 3 months after direct PCI. | 3 months after PCI | 
| renal replacement therapy and/or death from acute renal failure | renal replacement therapy and/or death from acute renal failure | 6 months after PCI | 
| Major adverse cardiac events | all-cause death, non-lethal acute myocardial infarction, revascularization | 6 months after PCI | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hydration, Contrast-induced Nephropathy, contrast induced acute kidney injury