Cardiogenic ShockPhase 2NCT02591771
Study of Multistep Pharmacological and Invasive Management for Cardiogenic Shock
A Phase 2 study testing adrenaline in people with Cardiogenic Shock, run by Niguarda Hospital at 2 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiogenic Shock
- What is being tested?
- adrenaline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesItaly
- Study dates
- Oct 2015to 31 Dec 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Niguarda Hospital
Milan, MI, 20162
Ospedale San Raffaele
Milan, 20132
About this study
Official title: Phase II Clinical Trial for a Stepwise Progression in the Treatment of Cardiogenic Shock
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.
Read the 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.
- Conditions
- Cardiogenic Shock
- Being tested
- adrenaline
- Keywords
- Adrenaline, Extra Corporeal Life Support, Inotropes
- Medical subject headings
- Shock, Cardiogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adrenalineDrug
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
| Study group | Role | What they receive |
|---|---|---|
| adrenaline | Experimental | 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 Receives: Drug: adrenaline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival at 60 days
number of successes
Measured: 60 days
Secondary outcomes (6)
Duration of i.v. infusion with adrenaline
Measured: 30 days
Adrenaline maximum dose
Measured: 30 days
Time to weaning from beginning with pharmacological therapy and mechanical ventricular support
Measured: 30 days
Length of stay
Measured: 30 days
Sum of medical staff support and nursing-care hours dedicated to each patient
Measured: Within patient hospitalization, each day from day 1 to day 30
Membrane oxygenation
Escalation to venoarterial extracorporeal membrane oxygenation (VA-ECMO)
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2015 (estimated)
- Study startOct 2015
- Primary completion25 Jul 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiogenic ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Niguarda Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ospedale San Raffaele
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02591771
- Sponsor's protocol ID
- AltShock
- Status last verified
- Jul 2021
- First submitted
- 11 Oct 2015
- Last updated
- 26 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30100052
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Clinical Trial for a Stepwise Progression in the Treatment of Cardiogenic Shock
- ClinicalTrials.gov ID
- NCT02591771
- Acronym / sponsor ID
- AltShock
- Conditions
- Cardiogenic Shock
- Keywords
- Adrenaline, Extra Corporeal Life Support, Inotropes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Niguarda HospitalUniversity, hospital or other
- Collaborators
- Ospedale San Raffaele
- Study start
- Oct 2015 (actual)
- Primary completion
- 25 Jul 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 30 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| adrenaline | Experimental | Drug: adrenalinei.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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| adrenalinei.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 | Drug | adrenaline |
Primary outcome
Survival at 60 days
Time frame: 60 days
number of successes
6 secondary outcomes
Duration of i.v. infusion with adrenaline
Time frame: 30 days
Adrenaline maximum dose
Time frame: 30 days
Time to weaning from beginning with pharmacological therapy and mechanical ventricular support
Time frame: 30 days
Length of stay
Time frame: 30 days
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
Membrane oxygenation
Time frame: 60 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2021.
- Results publication: PubMed 30100052Morici 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing adrenaline in people with Cardiogenic Shock, run by Niguarda Hospital at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival at 60 days (time frame: 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02591771, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2021.