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

C

Chinese PLA General Hospital (301 Hospital)

Status

Completed

Conditions

Myocardial Infarction
Contrast-induced Nephropathy

Treatments

Procedure: the adequate hydration group guided by Vigileo

Study type

Interventional

Funder types

Other

Identifiers

NCT04382313
sf2020-2-5012

Details and patient eligibility

About

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.

Full 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.

Enrollment

344 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

344 participants in 2 patient groups, including a placebo group

the adequate hydration group guided by Vigileo
Placebo Comparator group
Description:
The hydration speed is adjusted according to SVV or SV by Vigileo
Treatment:
Procedure: the adequate hydration group guided by Vigileo
the control group
No Intervention group
Description:
The routine hydration regimen is adopted, perioperative saline ≤500 ml hydration

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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