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

Not Applicable

Completed

• Conditions: Myocardial Infarction; Contrast-induced Nephropathy
• Interventions: Procedure: the adequate hydration group guided by Vigileo

• Registration Number: NCT04382313
• Lead Sponsor: Chinese PLA General Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2020-05-07
• Study First Submitted QC: 2020-05-08
• Study First Posted: 2020-05-11
• Study Start: 2020-07-10
• Status Verified: 2022-01
• Primary Completion: 2022-05-30
• Study Completion: 2022-12-21
• Last Update Submitted: 2023-01-01
• Last Update Posted: 2023-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 344

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
the adequate hydration group guided by Vigileo	the adequate hydration group guided by Vigileo	The hydration speed is adjusted according to SVV or SV by Vigileo

Primary Outcome Measures

Name	Time	Method
Contrast induced nephropathy	48-72 hours after PCI	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.

Secondary Outcome Measures

Name	Time	Method
The acute renal injury caused by contrast agent	48 hours after PCI	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.
Major adverse cardiac events	6 months after PCI	all-cause death, non-lethal acute myocardial infarction, revascularization
renal replacement therapy and/or death from acute renal failure	6 months after PCI	renal replacement therapy and/or death from acute renal failure
Persistent renal insufficiency	3 months after PCI	Persistent renal insufficiency is defined as at least 25% decrease compared with baseline in creatinine clearance 3 months after direct PCI.

Trial Locations

Locations (1)

Chinese People's Liberation Army General Hospital; 🇨🇳 Peking, Beijing, China