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Clinical Outcome and Cost-effectiveness of Reduced Noradrenaline by Using a Lower Blood Pressure Target in Patients With Cardiogenic Shock From Acute Myocardial Infarction (NORSHOCK)

Primary Purpose

Cardiogenic Shock, Myocardial Infarction

Status
Recruiting
Phase
Phase 4
Locations
Netherlands
Study Type
Interventional
Intervention
Reduced noradrenaline use
Sponsored by
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiogenic Shock focused on measuring Noradrenaline, Blood pressure target, Cardiogenic shock, Myocardial infarction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Planned early revascularization by PCI (percutaneous coronary intervention)
  2. a) Systolic blood pressure (SBP) <90 mmHg for > 30 minutes, OR b) Use of drugs to maintain SBP > 90 mmHg at presentation before randomization.
  3. Signs of pulmonary congestion

  4. Signs of impaired organ perfusion with at least one of the following criteria:

    1. Altered mental status
    2. Cold, clammy skin and extremities
    3. Oliguria with urine output <30ml/hour
    4. Serum lactate >2.0 mmol/L

Exclusion Criteria:

  • Resuscitation >30 minutes
  • No intrinsic heart action
  • Cerebral deficit with fixed dilated pupils (not drug-induced)
  • Mechanical cause of cardiogenic shock
  • Onset of shock >12 hours
  • Massive lung embolism
  • Shock due to other cause (bradycardia, sepsis, hypovolemia, etc.)

Sites / Locations

  • Amsterdam UMC, location AMCRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Reduced noradrenaline (MAP ≥ 55 mmHg)

Usual care (MAP ≥ 65 mmHg)

Arm Description

Outcomes

Primary Outcome Measures

Mortality and renal failure
Composite of all-cause mortality and severe renal failure leading to renal replacement therapy

Secondary Outcome Measures

Blood pressure (systolic and diastolic)
Blood pressure measured hourly during the first 24 hours of ICU/CCU admission
Heart rate
Heart rate, measured hourly during the first 24 hours of ICU/CCU admission
Enzymatic infarct size, measured by hs-Troponin T
Size of myocardial infarction, measured by hs-Troponin T
Enzymatic infarct size, measured by CK-MB
Size of myocardial infarction, measured by CK-MB
Need for mechanical circulatory support
Type of mechanical circulatory support device
Duration of mechanical ventilation
Duration of mechanical ventilation, expressed in days
Need for vasopressors / inotropes
The type of vasopressors / inotropes that were administrered
Ejection fraction, percent
As measured by echocardiography and/or MRI
Renal function
Renal function, measured by serum creatinin
Cost-effectiveness
Cost per patients alive without severe renal failure and costs per QALY (quality-adjusted life year)

Full Information

First Posted
November 8, 2021
Last Updated
February 23, 2023
Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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1. Study Identification

Unique Protocol Identification Number
NCT05168462
Brief Title
Clinical Outcome and Cost-effectiveness of Reduced Noradrenaline by Using a Lower Blood Pressure Target in Patients With Cardiogenic Shock From Acute Myocardial Infarction
Acronym
NORSHOCK
Official Title
Clinical Outcome and Cost-effectiveness of Reduced Noradrenaline by Using a Lower Blood Pressure Target in Patients With Cardiogenic Shock From Acute Myocardial Infarction
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
June 1, 2025 (Anticipated)
Study Completion Date
June 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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
Rationale: Pump failure due to acute myocardial infarction (AMI) can lead to cardiogenic shock (CS): a state of low blood flow to end-organs with subsequent multi-organ failure that is associated with high mortality rated. The first line pharmacologic treatment strategy in CS is noradrenaline. This vasopressor drug is used to maintain adequate blood pressures. The assumption is that a mean arterial blood pressure (MAP) ≥ 65 mmHg will improve flow and thereby tissue perfusion of myocardium and other tissues (e.g. renal). However, there is no evidence that an increase in MAP, if achieved by noradrenaline, leads to greater end-organ blood flow and better outcomes. Objective: With this study the investigators aim to investigate the (cost-)effectiveness of reduced noradrenaline in patients with CS by using a lower MAP target of ≥ 55 mmHg, compared to ≥ 65 mmHg. The investigators hypothesize that reduced use of noradrenaline will improve overall survival and decrease renal failure requiring renal replacement therapy. Study design: Open label, randomized controlled multicenter trial Study population: Adults patients with CS due to AMI Intervention: Treatment strategy of reduced noradrenaline, by using a lower MAP target ( ≥ 55 mmHg). Main study endpoint: composite of all-cause mortality and severe renal failure leading to renal replacement therapy within 30-days after randomization.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiogenic Shock, Myocardial Infarction
Keywords
Noradrenaline, Blood pressure target, Cardiogenic shock, Myocardial infarction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
776 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Reduced noradrenaline (MAP ≥ 55 mmHg)
Arm Type
Experimental
Arm Title
Usual care (MAP ≥ 65 mmHg)
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Reduced noradrenaline use
Intervention Description
Reduced noradrenaline by using a lower MAP target
Primary Outcome Measure Information:
Title
Mortality and renal failure
Description
Composite of all-cause mortality and severe renal failure leading to renal replacement therapy
Time Frame
30-days
Secondary Outcome Measure Information:
Title
Blood pressure (systolic and diastolic)
Description
Blood pressure measured hourly during the first 24 hours of ICU/CCU admission
Time Frame
The first 24 hours
Title
Heart rate
Description
Heart rate, measured hourly during the first 24 hours of ICU/CCU admission
Time Frame
The first 24 hours
Title
Enzymatic infarct size, measured by hs-Troponin T
Description
Size of myocardial infarction, measured by hs-Troponin T
Time Frame
0, 6, 12, 24, 36 and 72 hours
Title
Enzymatic infarct size, measured by CK-MB
Description
Size of myocardial infarction, measured by CK-MB
Time Frame
0, 6, 12, 24, 36 and 72 hours
Title
Need for mechanical circulatory support
Description
Type of mechanical circulatory support device
Time Frame
Recorded after ICU/CCU discharge, assessed up to 60 days
Title
Duration of mechanical ventilation
Description
Duration of mechanical ventilation, expressed in days
Time Frame
Recorded after ICU/CCU discharge, assessed up to 60 days
Title
Need for vasopressors / inotropes
Description
The type of vasopressors / inotropes that were administrered
Time Frame
Recorded after ICU/CCU discharge, assessed up to 60 days
Title
Ejection fraction, percent
Description
As measured by echocardiography and/or MRI
Time Frame
72 hours and 1 year
Title
Renal function
Description
Renal function, measured by serum creatinin
Time Frame
1 year
Title
Cost-effectiveness
Description
Cost per patients alive without severe renal failure and costs per QALY (quality-adjusted life year)
Time Frame
1-year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Acute myocardial infarction, STEMI or NSTEMI Early revascularization by PCI Cardiogenic shock, characterized by: I. a. Systolic blood pressure (SBP) ≤ 90 mmHg for > 30 minutes, OR b. Use of drugs to maintain SBP > 90 mmHg at randomization. II. Clinical signs of impaired organ perfusion with at least one of the following criteria: Altered mental status Cold, clammy skin and extremities Oliguria with urine output < 30ml/hour Serum lactate > 2.0 mmol/L III. Clinical signs of pulmonary congestion Exclusion Criteria: Resuscitation > 30 minutes Mechanical cause of cardiogenic shock (e.g. papillary muscle rupture, ventricular septal rupture) Onset of shock > 12 hours Imminent need for mechanical circulatory support
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elma Peters
Phone
0205668380
Email
e.j.peters@amsterdamumc.nl
Facility Information:
Facility Name
Amsterdam UMC, location AMC
City
Amsterdam
ZIP/Postal Code
1105AZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose Henriques
Email
j.p.henriques@amsterdamumc.nl

12. IPD Sharing Statement

Learn more about this trial

Clinical Outcome and Cost-effectiveness of Reduced Noradrenaline by Using a Lower Blood Pressure Target in Patients With Cardiogenic Shock From Acute Myocardial Infarction

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