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Study of Multistep Pharmacological and Invasive Management for Cardiogenic Shock

Primary Purpose

Cardiogenic Shock

Status

Completed

Phase

Phase 2

Locations

Italy

Study Type

Interventional

Intervention

adrenaline

About this trial

This is an interventional treatment trial for Cardiogenic Shock focused on measuring Adrenaline, Extra Corporeal Life Support, Inotropes

Eligibility Criteria

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

Inclusion Criteria

Age ≥ 18 and < 75, men and women;
1) SBP < 90mmHg or MAP < 60 mmHg, after an appropriate fluid challenge if there is no sign of overt fluid overload; OR 2) need of vasoactive agents to maintain SBP > 90 mmHg or MAP > 60 mmHg.
Pre-existing diagnosis of heart failure with reduced ejection fraction (left ventricle systolic function ≤35%).
Moreover, eligible patients have to fit at least ONE of the following criteria/items of overt hypoperfusion: mixed venous oxygen saturation < 60%; arterial lactates > 2 mmol/L; oliguria < 0.5 ml/Kg/h for at least 6 hours.
Eligible patients shouldn't have contraindications to HRT.

Exclusion Criteria

Cardiogenic shock symptoms beyond 6 hours.
Septic shock with evident septic focus.
Cardiogenic shock due to acute myocardial infarction.
Cardiogenic shock due to acute myocarditis.
Cardiogenic shock due to pulmonary thromboembolism.
Reiterating major arrhythmias: VT or VF or AF, with ventricular rate > 160 bpm.
Severe aortic valve disease.
Obstructive hypertrophic cardiomyopathy or constrictive pericarditis or severe heart failure due to congenital heart disease
Severe peripheral vascular disease that contraindicates mechanical support insertion.
Cardiogenic shock secondary to either cardiac or non-cardiac surgery.
Post-cardiac arrest syndrome following out of hospital cardiac arrest
Comorbidities with ominous prognosis (life expectancy < 1 year).
End-stage organ failure.
Pregnant, lactating or subjects planning pregnancy during the course of the trial.
Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.

Sites / Locations

Niguarda Hospital
Ospedale San Raffaele

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

adrenaline

Arm Description

i.v. adrenaline infusion as an early and fast haemodynamic stabilizer, associated with a tight tissue perfusion monitoring, in the context of a stepwise progression in the treatment of cardiogenic shock, including ventricular mechanical support

Outcomes

Primary Outcome Measures

Survival at 60 days

number of successes

Secondary Outcome Measures

Duration of i.v. infusion with adrenaline

Adrenaline maximum dose

Time to weaning from beginning with pharmacological therapy and mechanical ventricular support

Length of stay

Sum of medical staff support and nursing-care hours dedicated to each patient

Membrane oxygenation

Escalation to venoarterial extracorporeal membrane oxygenation (VA-ECMO)

Full Information

NCT ID

NCT02591771

First Posted

October 11, 2015

Last Updated

July 19, 2021

Sponsor

Niguarda Hospital

Collaborators

Ospedale San Raffaele

1. Study Identification

Unique Protocol Identification Number

NCT02591771

Brief Title

Study of Multistep Pharmacological and Invasive Management for Cardiogenic Shock

Official Title

Phase II Clinical Trial for a Stepwise Progression in the Treatment of Cardiogenic Shock

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Completed

Study Start Date

October 2015 (Actual)

Primary Completion Date

July 25, 2017 (Actual)

Study Completion Date

December 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Niguarda Hospital

Collaborators

Ospedale San Raffaele

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to evaluate efficacy and safety of i.v. adrenaline infusion as an early and fast haemodynamic stabilizer, associated with a tight tissue perfusion monitoring, in the context of a stepwise progression in the treatment of cardiogenic shock, including ventricular mechanical support.

Detailed Description

Cardiogenic shock is characterized by a decrease in cardiac output and increased ventricular pressures, with subsequent symptoms and signs of systemic hypoperfusion. In spite of the multiple pharmacological chances the in-hospital mortality rate is still very high (around 60% of patients) and nowadays there is not a therapeutic "reference standard" associated with an improved survival at short and midterm. Adrenaline is a mainstay of resuscitation therapy during cardiopulmonary arrest, however, it is not clear whether this inotrope actually facilitates an improvement in patients affected by cardiogenic shock. In a small local evidence-based experience, contrary to current opinion, it has been shown that adrenaline may still have a role in the treatment of patients with low output state. This phase II study tests the hypothesis that adrenaline infusion, integrated in a multistep approach at increasing intensity, can be a valid support with limited side effects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cardiogenic Shock

Keywords

Adrenaline, Extra Corporeal Life Support, Inotropes

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

adrenaline

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

adrenaline

Intervention Description

Primary Outcome Measure Information:

Title

Survival at 60 days

Description

number of successes

Time Frame

60 days

Secondary Outcome Measure Information:

Title

Duration of i.v. infusion with adrenaline

Time Frame

30 days

Title

Adrenaline maximum dose

Time Frame

30 days

Title

Time to weaning from beginning with pharmacological therapy and mechanical ventricular support

Time Frame

30 days

Title

Length of stay

Time Frame

30 days

Title

Sum of medical staff support and nursing-care hours dedicated to each patient

Time Frame

Within patient hospitalization, each day from day 1 to day 30

Title

Membrane oxygenation

Description

Escalation to venoarterial extracorporeal membrane oxygenation (VA-ECMO)

Time Frame

60 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria Age ≥ 18 and < 75, men and women; 1) SBP < 90mmHg or MAP < 60 mmHg, after an appropriate fluid challenge if there is no sign of overt fluid overload; OR 2) need of vasoactive agents to maintain SBP > 90 mmHg or MAP > 60 mmHg. Pre-existing diagnosis of heart failure with reduced ejection fraction (left ventricle systolic function ≤35%). Moreover, eligible patients have to fit at least ONE of the following criteria/items of overt hypoperfusion: mixed venous oxygen saturation < 60%; arterial lactates > 2 mmol/L; oliguria < 0.5 ml/Kg/h for at least 6 hours. Eligible patients shouldn't have contraindications to HRT. Exclusion Criteria Cardiogenic shock symptoms beyond 6 hours. Septic shock with evident septic focus. Cardiogenic shock due to acute myocardial infarction. Cardiogenic shock due to acute myocarditis. Cardiogenic shock due to pulmonary thromboembolism. Reiterating major arrhythmias: VT or VF or AF, with ventricular rate > 160 bpm. Severe aortic valve disease. Obstructive hypertrophic cardiomyopathy or constrictive pericarditis or severe heart failure due to congenital heart disease Severe peripheral vascular disease that contraindicates mechanical support insertion. Cardiogenic shock secondary to either cardiac or non-cardiac surgery. Post-cardiac arrest syndrome following out of hospital cardiac arrest Comorbidities with ominous prognosis (life expectancy < 1 year). End-stage organ failure. Pregnant, lactating or subjects planning pregnancy during the course of the trial. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.

Facility Information:

Facility Name

Niguarda Hospital

City

Milan

State/Province

ZIP/Postal Code

20162

Country

Italy

Facility Name

Ospedale San Raffaele

City

Milano

ZIP/Postal Code

20132

Country

Italy

12. IPD Sharing Statement

Citations:

PubMed Identifier

30100052

Citation

Morici N, Oliva F, Ajello S, Stucchi M, Sacco A, Cipriani MG, De Bonis M, Garascia A, Gagliardone MP, Melisurgo G, Russo CF, La Vecchia C, Frigerio M, Pappalardo F. Management of cardiogenic shock in acute decompensated chronic heart failure: The ALTSHOCK phase II clinical trial. Am Heart J. 2018 Oct;204:196-201. doi: 10.1016/j.ahj.2018.07.009. Epub 2018 Jul 20.

Results Reference

result

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Study of Multistep Pharmacological and Invasive Management for Cardiogenic Shock

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