Cardiogenic Shock Integrated PHenotyping for Event Reduction
ConditionHeart Failure
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-74
SponsorNiguarda Hospital
About this trial
The purpose of this study is to better understand the time course of different biological mechanisms involved in acute decompensated heart failure complicated by cardiogenic shock throughout the evaluation of changes and the relationship among markers of inflammation (IL-6) and markers of increased endothelial permeability (Ang-2) or endothelial glycocalyx perturbation (Syndecan-1 and HS) and throughout a targeted metabolomic approach.
Eligibility criteria
Qualifiers
Age ≥ 18 and < 75, men and women;
1) Systolic blood pressure (SBP) < 90mmHg or mean arterial pressure (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.
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: altered state of consciousness; sweaty and cold skin; mixed venous oxygen saturation < 60%; arterial lactates > 2 mmol/L; oliguria < 0.5 ml/Kg/h for at least 6 hours.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- ELISA
Treatment groups
26 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov