NCT04382313

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 344 (actual)
• Sponsor: Chinese PLA General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Myocardial Infarction
• Contrast-induced Nephropathy

Interventions

Type	Name	Description
PROCEDURE	the adequate hydration group guided by Vigileo	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.

Timeline

• Start date: 2020-07-10
• Primary completion: 2022-05-30
• Completion: 2022-12-21
• First posted: 2020-05-11
• Last updated: 2023-01-04

Locations

1 site across 1 country: China