Study of Multistep Pharmacological and Invasive Management for Cardiogenic Shock
Phase II Clinical Trial for a Stepwise Progression in the Treatment of Cardiogenic Shock
1 other identifier
interventional
24
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Oct 2015
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 11, 2015
CompletedFirst Posted
Study publicly available on registry
October 30, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 25, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2017
CompletedJuly 26, 2021
July 1, 2021
1.8 years
October 11, 2015
July 19, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Survival at 60 days
number of successes
60 days
Secondary Outcomes (6)
Duration of i.v. infusion with adrenaline
30 days
Adrenaline maximum dose
30 days
Time to weaning from beginning with pharmacological therapy and mechanical ventricular support
30 days
Length of stay
30 days
Sum of medical staff support and nursing-care hours dedicated to each patient
Within patient hospitalization, each day from day 1 to day 30
- +1 more secondary outcomes
Study Arms (1)
adrenaline
EXPERIMENTALi.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
Interventions
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
Eligibility Criteria
You may qualify if:
- Age ≥ 18 and \< 75, men and women;
- \) 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Niguarda Hospitallead
- Ospedale San Raffaelecollaborator
Study Sites (2)
Niguarda Hospital
Milan, MI, 20162, Italy
Ospedale San Raffaele
Milan, 20132, Italy
Related Publications (1)
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.
PMID: 30100052RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 11, 2015
First Posted
October 30, 2015
Study Start
October 1, 2015
Primary Completion
July 25, 2017
Study Completion
December 31, 2017
Last Updated
July 26, 2021
Record last verified: 2021-07