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

January 1, 2023 updated by: Qian geng, Chinese PLA General Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

344

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Peking, Beijing, China, 100853
        • Chinese People's Liberation Army General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
48-72 hours after PCI

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
48 hours after PCI
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 months after PCI
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
6 months after PCI
Major adverse cardiac events
Time Frame: 6 months after PCI
all-cause death, non-lethal acute myocardial infarction, revascularization
6 months after PCI

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese PLA General Hospital

Collaborators

Lu jiang hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 10, 2020

Primary Completion (Actual)

May 30, 2022

Study Completion (Actual)

December 21, 2022

Study Registration Dates

First Submitted

May 7, 2020

First Submitted That Met QC Criteria

May 8, 2020

First Posted (Actual)

May 11, 2020

Study Record Updates

Last Update Posted (Actual)

January 4, 2023

Last Update Submitted That Met QC Criteria

January 1, 2023

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • sf2020-2-5012

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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