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

Primary Purpose

Myocardial Infarction, Contrast-induced Nephropathy

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
the adequate hydration group guided by Vigileo
Sponsored by
Chinese PLA General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Myocardial Infarction focused on measuring Hydration, Contrast-induced Nephropathy, contrast induced acute kidney injury

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Chinese People's Liberation Army General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

No Intervention

Arm Label

the adequate hydration group guided by Vigileo

the control group

Arm Description

The hydration speed is adjusted according to SVV or SV by Vigileo

The routine hydration regimen is adopted, perioperative saline ≤500 ml hydration

Outcomes

Primary Outcome Measures

Contrast induced nephropathy
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

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

Full Information

First Posted
May 7, 2020
Last Updated
January 1, 2023
Sponsor
Chinese PLA General Hospital
Collaborators
Lu jiang hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04382313
Brief Title
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

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
July 10, 2020 (Actual)
Primary Completion Date
May 30, 2022 (Actual)
Study Completion Date
December 21, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese PLA General Hospital
Collaborators
Lu jiang hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction, Contrast-induced Nephropathy
Keywords
Hydration, Contrast-induced Nephropathy, contrast induced acute kidney injury

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
344 (Actual)

8. Arms, Groups, and Interventions

Arm Title
the adequate hydration group guided by Vigileo
Arm Type
Placebo Comparator
Arm Description
The hydration speed is adjusted according to SVV or SV by Vigileo
Arm Title
the control group
Arm Type
No Intervention
Arm Description
The routine hydration regimen is adopted, perioperative saline ≤500 ml hydration
Intervention Type
Procedure
Intervention Name(s)
the adequate hydration group guided by Vigileo
Intervention Description
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 Outcome Measure Information:
Title
Contrast induced nephropathy
Description
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.
Time Frame
48-72 hours after PCI
Secondary Outcome Measure Information:
Title
The acute renal injury caused by contrast agent
Description
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.
Time Frame
48 hours after PCI
Title
Persistent renal insufficiency
Description
Persistent renal insufficiency is defined as at least 25% decrease compared with baseline in creatinine clearance 3 months after direct PCI.
Time Frame
3 months after PCI
Title
renal replacement therapy and/or death from acute renal failure
Description
renal replacement therapy and/or death from acute renal failure
Time Frame
6 months after PCI
Title
Major adverse cardiac events
Description
all-cause death, non-lethal acute myocardial infarction, revascularization
Time Frame
6 months after PCI

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Chinese People's Liberation Army General Hospital
City
Peking
State/Province
Beijing
ZIP/Postal Code
100853
Country
China

12. IPD Sharing Statement

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

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