Altshock-2 REGISTRY
ConditionCardiogenic Shock
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNiguarda Hospital
About this trial
The study will provide data on profile, management, outcome, and evolution over time of cardiogenic shock patients admitted to the Intensive Coronary Care Units
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Systolic blood pressure (SBP) <90 mmHg or mean arterial pressure (MAP) <60 mmHg, after an appropriate fluid challenge if there is no sign of overt fluid overload, OR need of vasoactive agents to maintain SBP > 90 mmHg or MAP > 60 mmHg, OR need of MCS;
At least one of the following criteria/signs of overt hypoperfusion: mixed venous oxygen saturation <60%; arterial lactates > 2 mmol/L; oliguria < 0.5 ml/Kg/h for at least 6 hours.
Disqualifiers
None
Trial population
All-comers cardiogenic shock patients admitted to the Intensive Coronary Care Units
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
3,000 Participants
are grouped into 1 trial groupGroup A: cardiogenic shock patients
Trial outcomes
Primary outcomes
1
To provide data on profile, management, outcome, and evolution over time of CS patients admitted to ICCU
No formal sample size calculation was used to manage enrolment in the registry since the goal is to obtain participation by all possible eligible patients. No formal pre-specified hypothesis testing is planned. All analyses will be descriptive in nature Accordingly, measures of primary outcome will not be provided
Time frame
10 years2
Re-hospitalization
Number of patients
Time frame
10 yearsSecondary outcomes
1
To collect data on clinical characteristics and management of cardiogenic shock patients
Accordingly to the descriptive nature of the analyses, measures of secondary outcome will not be provided
Time frame
10 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov