Cardiogenic ShockNCT05586282
Role of Candidate Proteins in Capillary Leakage During Acute Circulatory Failure
An observational study of Cardiogenic Shock and Postresuscitation Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiogenic Shock, Postresuscitation Disease, Septic Shock
- How many people
- 380 participants
- Where
- 1 siteFrance
- Study dates
- 20 Mar 2023to Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients hospitalized in ICU with a circulatory failure due to septic shock, cardiogenic shock, or post-resuscitation syndrome.
Who may be able to join
- 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
Show all 19Show fewer
- 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%
Who cannot join
- Onset of shock (catecholamine infusion) >12 hours prior to inclusion
- Age <18 year old
- Pregnancy
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hôpital Européen Georges Pompidou
Paris, 75015
Nicolas BRECHOT, MD, PhD, +33 1 56 09 23 42, nicolas.brechot@aphp.fr
Nicolas BRECHOT, MD, PhD
About this study
- 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
Read the detailed description
Circulatory shocks are responsible for one third of intensive care unit (ICU) admissions (20,000 patients per year in France) and are associated with 40% mortality [1,2]. Vascular hyperpermeability (also called vascular leakage) is a major feature of circulatory failure. During systemic inflammatory response syndrome (SIRS), massive vascular leakage affects macro and micro-circulation, and participates in the development of multiple organ failure [1,3]. Accordingly, fluid balance (the difference between fluid input and output) correlates independently with mortality during both septic and cardiogenic shock [4-7] and controlling capillary leakage was highly beneficial in numerous animal models of circulatory failure [8-10]. However, the determinants of vascular leakage remain poorly understood in humans.
The purpose of this study is to evaluate the link between circulatory levels of several proteins and the level of vascular leakage, in three distinct types of circulatory shocks.
- Conditions
- Cardiogenic Shock, Postresuscitation Disease, Septic Shock
- Medical subject headings
- Shock, Cardiogenic, Post-Cardiac Arrest Syndrome, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with a circulatory failure | All patients hospitalized in ICU with a circulatory failure due to septic shock, cardiogenic shock, or post-resuscitation syndrome. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fluid balance from Day 0 to day 3
(ml/kg of initial body weight). The fluid balance, routinely monitored in ICU, represents fluid intakes (perfusion, oral intakes,..) - fluid losses (diuresis, diarrhea,…)
Measured: Between Day 0 and Day 3
Secondary outcomes (14)
Fluid balance
(ml/kg of initial body weight). The fluid balance, routinely monitored in ICU, represents fluid intakes (perfusion, oral intakes,..) - fluid losses (diuresis, diarrhea,…)
Measured: Day 1, Day 3, Day 7, Day 14
Extra-vascular lung water index
Extra-vascular lung water index (EVLWi, ml/kg) and pulmonary vascular permeability index measured by transpulmonary thermodilution at corresponding time-points
Measured: Day 0, Day 1, Day 3, Day 7, Day 14
Serum albuminemia
g/L
Measured: Day 0, Day 1, Day 3, Day 7, Day 14
Serum lactatemia
mmoles/L
Measured: Day 0, Day 1, Day 3, Day 7, Day 14
Arterial PaO2
(mmHg)
Measured: Day 0, Day 1, Day 3, Day 7, Day 14
Circulating cytokine inflammatory profile IL-33
(pg/ml)
Measured: Day 0, Day 1, Day 3, Day 7, Day 14
Circulating cytokine inflammatory profile TNF-alpha
(pg/ml)
Measured: Day 0, Day 1, Day 3, Day 7, Day 14
Circulating cytokine inflammatory profile IL-6
(pg/ml)
Measured: Day 0, Day 1, Day 3, Day 7, Day 14
Circulating cytokine inflammatory profile IL-1
(pg/ml)
Measured: Day 0, Day 1, Day 3, Day 7, Day 14
SOFA score
Association between circulating candidate proteins, the immune-inflammatory profile of the patients and SOFA score
Measured: Day 0, Day 1, Day 3, Day 7, Day 14
Catecholamine-free days
Number of days alive without receiving any catecholamine
Measured: Day 0 to Day 7, Day 30
Ventilatory-free days
Number of days alive without receiving any machenical ventilation, invasive or non-invasive
Measured: Day 0 to Day 7, Day 30
Renal replacement therapy-free
Number of days alive without receiving any renal replacement therapy
Measured: Day 0 to Day 7, Day 30
Mortality
Measured: Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2022
- Study start20 Mar 2023
- Primary completionMar 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiogenic ShockStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 380 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05586282
- Sponsor's protocol ID
- APH211381
- Status last verified
- Oct 2024
- First submitted
- 11 Oct 2022
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Candidate Proteins in Capillary Leakage During Acute Circulatory Failure
- ClinicalTrials.gov ID
- NCT05586282
- Acronym / sponsor ID
- APH211381
- Conditions
- Cardiogenic Shock, Postresuscitation Disease, Septic Shock
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 380 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 20 Mar 2023 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 19 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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
Detailed description
Circulatory shocks are responsible for one third of intensive care unit (ICU) admissions (20,000 patients per year in France) and are associated with 40% mortality [1,2]. Vascular hyperpermeability (also called vascular leakage) is a major feature of circulatory failure. During systemic inflammatory response syndrome (SIRS), massive vascular leakage affects macro and micro-circulation, and participates in the development of multiple organ failure [1,3]. Accordingly, fluid balance (the difference between fluid input and output) correlates independently with mortality during both septic and cardiogenic shock [4-7] and controlling capillary leakage was highly beneficial in numerous animal models of circulatory failure [8-10]. However, the determinants of vascular leakage remain poorly understood in humans.
The purpose of this study is to evaluate the link between circulatory levels of several proteins and the level of vascular leakage, in three distinct types of circulatory shocks.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with a circulatory failure | – | –All patients hospitalized in ICU with a circulatory failure due to septic shock, cardiogenic shock, or post-resuscitation syndrome. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients hospitalized in ICU with a circulatory failure due to septic shock, cardiogenic shock, or post-resuscitation syndrome.
Key inclusion criteria (19 listed)
- 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:
Key exclusion criteria (3 listed)
- Onset of shock (catecholamine infusion) >12 hours prior to inclusion
- Age <18 year old
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fluid balance from Day 0 to day 3
Time frame: Between Day 0 and Day 3
(ml/kg of initial body weight). The fluid balance, routinely monitored in ICU, represents fluid intakes (perfusion, oral intakes,..) - fluid losses (diuresis, diarrhea,…)
14 secondary outcomes
Fluid balance
Time frame: Day 1, Day 3, Day 7, Day 14
Extra-vascular lung water index
Time frame: Day 0, Day 1, Day 3, Day 7, Day 14
Serum albuminemia
Time frame: Day 0, Day 1, Day 3, Day 7, Day 14
Serum lactatemia
Time frame: Day 0, Day 1, Day 3, Day 7, Day 14
Arterial PaO2
Time frame: Day 0, Day 1, Day 3, Day 7, Day 14
Circulating cytokine inflammatory profile IL-33
Time frame: Day 0, Day 1, Day 3, Day 7, Day 14
Circulating cytokine inflammatory profile TNF-alpha
Time frame: Day 0, Day 1, Day 3, Day 7, Day 14
Circulating cytokine inflammatory profile IL-6
Time frame: Day 0, Day 1, Day 3, Day 7, Day 14
Circulating cytokine inflammatory profile IL-1
Time frame: Day 0, Day 1, Day 3, Day 7, Day 14
SOFA score
Time frame: Day 0, Day 1, Day 3, Day 7, Day 14
Catecholamine-free days
Time frame: Day 0 to Day 7, Day 30
Ventilatory-free days
Time frame: Day 0 to Day 7, Day 30
Renal replacement therapy-free
Time frame: Day 0 to Day 7, Day 30
Mortality
Time frame: Day 30
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiogenic Shock and Postresuscitation Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nicolas BRECHOT, MD, PhD (+331 56 09 23 42, nicolas.brechot@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fluid balance from Day 0 to day 3 (time frame: Between Day 0 and Day 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.