NCT05586282 Role of Candidate Proteins in Capillary Leakage During Acute Circulatory Failure
| NCT ID | NCT05586282 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Cardiogenic Shock |
| Study Type | OBSERVATIONAL |
| Enrollment | 380 participants |
| Start Date | 2023-03-20 |
| Primary Completion | 2026-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 380 participants in total. It began in 2023-03-20 with a primary completion date of 2026-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
* 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
Eligibility Criteria
Inclusion Criteria: 1. 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. 2. Affiliation to social security (AME excluded) 3. 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: 1. Onset of shock (catecholamine infusion) \>12 hours prior to inclusion 2. Age \<18 year old 3. Pregnancy
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05586282 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cardiogenic Shock. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05586282 currently recruiting?
Yes, NCT05586282 is actively recruiting participants. Contact the research team at nicolas.brechot@aphp.fr for enrollment information.
Where is the NCT05586282 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT05586282 clinical trial?
NCT05586282 is sponsored by Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 380 participants.