Clinical trial NCT04382313: Effect of Hydration Guided by Vigileo on the Prevention of CIN After PCI for Patients With AMI
Official title: Effect of Hydration Guided by Vigileo on the Prevention of Contrast Induced Nephropathy After Emergency PCI for Patients With Acute Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myocardial Infarction
Contrast-induced Nephropathy
Keywords: Hydration
Contrast-induced Nephropathy
contrast induced acute kidney injury
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
Collaborators: name: Lu jiang hospital
First posted: 2020-05-11
Enrollment: 344
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Contrast induced nephropathy
timeFrame: 48-72 hours after PCI
Secondary outcomes:
measure: The acute renal injury caused by contrast agent
timeFrame: 48 hours after PCI
measure: Persistent renal insufficiency
timeFrame: 3 months after PCI
measure: renal replacement therapy and/or death from acute renal failure
timeFrame: 6 months after PCI
measure: Major adverse cardiac events
timeFrame: 6 months after PCI
Other outcomes:
Locations:
city: Peking
country: China
facility: Chinese People's Liberation Army General Hospital
state: Beijing
Study officials:
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