Role of Candidate Proteins in Capillary Leakage During Acute Circulatory Failure
Recruiting · NCT05586282 · Observational (researchers observe without assigning treatment) · Lead sponsor: Assistance Publique - Hôpitaux de Paris
View the official record on ClinicalTrials.gov →What this trial is about
* Testing the association between circulating candidate proteins and the level of vascular leakage for three distinct forms of circulatory failure: cardiogenic shock, septic shock, and post-resuscitation syndrome. * Describing immuno-inflammatory profiles associated with massive vascular leakage during those three forms of circulatory failure in humans
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- Informed consent from patient or a legal representative/family member/close relative. The patient will be asked to give his/her consent for the continuation of the trial when his/her condition will allow.
- Affiliation to social security (AME excluded)
- Patient with one of the circulatory failures described below:
- septic shock
- cardiogenic shock
- post-resuscitation syndrome
- Cardiogenic shock:
- Need for a catecholamine support to maintain mean arterial pressure\>65 mmHg, AND
- Cardiac index \<2 L/min/m2 or left ventricular ejection fraction (LVEF)\<35%, AND
- Lactate \>2.0 mmol/l
- Post-resuscitation syndrome:
- Cardiac arrest (absence of spontaneous respiration, palpable heartbeat, and responsiveness to stimuli\> 1 min) with a compatible electrocardiogram (asystole/pulseless electrical activity/ventricular tachycardia), AND
- Need for a catecholamine support to maintain mean arterial pressure\>65 mmHg, AND
- Lactate \>2.0 mmol/l
- Septic shock:
- Suspected or proven bacterial infection
- Need for a vasopressor support to maintain mean arterial pressure\>65 mmHg
- Lactate \>2.0 mmol/l
- Cardiac index\>3L/min/m2 or LVEF\>40%
Exclusion criteria
- Onset of shock (catecholamine infusion) \>12 hours prior to inclusion
- Age \<18 year old
- Pregnancy
Where it is running
1 location listed.
- Hôpital Européen Georges Pompidou - Paris, France