Investigating proteins linked to capillary leakage in circulatory failure
Role of Candidate Proteins in Capillary Leakage During Acute Circulatory Failure
Assistance Publique - Hôpitaux de Paris · NCT05586282
This study is trying to see if certain proteins in the blood are linked to fluid leaking from blood vessels in patients with different types of circulatory failure.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 380 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris (other) |
| Locations | 1 site (Paris) |
| Trial ID | NCT05586282 on ClinicalTrials.gov |
What this trial studies
This study examines the relationship between circulating candidate proteins and vascular leakage in patients experiencing three types of circulatory failure: cardiogenic shock, septic shock, and post-resuscitation syndrome. It aims to describe the immuno-inflammatory profiles associated with significant vascular leakage during these conditions. By understanding the determinants of vascular leakage in humans, the study seeks to provide insights that could improve patient management in intensive care settings.
Who should consider this trial
Good fit: Ideal candidates include patients diagnosed with septic shock, cardiogenic shock, or post-resuscitation syndrome who meet specific clinical criteria.
Not a fit: Patients without one of the specified forms of circulatory failure or those unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better understanding and management of vascular leakage, potentially reducing mortality in critically ill patients.
How similar studies have performed: While the study addresses a critical area of research, the specific approach of linking candidate proteins to vascular leakage in humans is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Paris
- Hôpital Européen Georges Pompidou — Paris, France (RECRUITING)
Study contacts
- Study coordinator: Nicolas BRECHOT, MD, PhD
- Email: nicolas.brechot@aphp.fr
- Phone: +331 56 09 23 42
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cardiogenic Shock, Postresuscitation Disease, Septic Shock