Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Acute Myocardial Infarction
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Prevention

Participation Requirements

Age
Between 18 years and 80 years
Gender
Both males and females

Description

This study was conducted in patients with acute myocardial infarction who undergo direct 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, Vigi...

This study was conducted in patients with acute myocardial infarction who undergo direct 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 flow parameters of blood flow. The specific scheme is: 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 5 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 5 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. 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 (left ventricular ejection fraction, left ventricular end-diastolic diameter, brain natriuretic peptide) 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 direct PCI was clarified.

Tracking Information

NCT #
NCT04382313
Collaborators
Not Provided
Investigators
Not Provided