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NCT Number: NCT04382313

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

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.

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Key information

Conditions

Myocardial Infarction Cardiovascular Diseases Contrast-induced Nephropathy Heart Diseases Infarction Ischemia Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chinese People's Liberation Army General Hospital

Beijing, Beijing Municipality, 100853, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

the adequate hydration group guided by Vigileo

Procedure

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.

Primary outcomes

  1. Contrast induced nephropathy

    Time frame: 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 outcomes

  1. The acute renal injury caused by contrast agent

    Time frame: 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.

  2. Persistent renal insufficiency

    Time frame: 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.

  3. renal replacement therapy and/or death from acute renal failure

    Time frame: 6 months after PCI

    renal replacement therapy and/or death from acute renal failure

  4. Major adverse cardiac events

    Time frame: 6 months after PCI

    all-cause death, non-lethal acute myocardial infarction, revascularization

Sponsors and collaborators

Lead sponsor

Chinese PLA General Hospital

Other

Collaborators

  • Lu jiang hospital

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
May 11, 2020
Registry last updated
Jan 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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