BridgeMD
Rapid rEcognition of COrticosteroid Resistant or sentive Sepsis - RECORDS
EU CTIS ID: 2024-516407-16-00
What this study is testing
To compare the effect hydrocortisone plus fludrocortisone vs. placebo on a composite of death or persistent organ dysfunction – defined as continued dependency on mechanical ventilation, new renal replacement therapy, or vasopressors – assessed at 90 days on intensive care unit (ICU) adults and having different biological profiles for immune responses and corticosteroids bioactivity
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients ≥ 18 years old
- Admitted to the ICU with proven or suspected infection as the main diagnosis
- Community acquired pneumonia related sepsis OR vasopressors dependency (norepinephrine, epinephrine, vasopressin, dopamine, phenylephrine) OR septic shock (Singer 2016: vasopressor to maintain mean blood pressure of at least 65 mmHg and lactate levels above 2 mmol/l) OR acute respiratory distress syndrome (ARDS – Ranieri 2012: a- acute onset, i.e. within one week of an apparent clinical insult and with progression of respiratory syndrome, b- bilateral opacities on chest imaging not explained by other pulmonary pathologies, e.g. pleural effusion, atelectasis, nodules etc, c- no evidence for heart failure or volume overload, d- PaO2/FiO2 ≤ 300 mm Hg, - PEEP ≥ 5 cm H2O
- Patient who has signed an informed and written consent whevener he/she is able of consent, if not ascent from his/her representant whenever he/she is present at time of screening for inclusion
- Patients who have been tested for one or more RECORDS specific biomarkers : o CIRCI o Endocan o GILZ o DUSP-1 o MDW o lymphopenia o Transcriptomic SRS2 o Endotype B o PCR COVID19 o PCR Influenza o PCR other respiratory virus o Cutaneous vasoconstrictor response to glucocorticoids o PCR NFKB1-GLCCI1 o Nucleosome
- Affiliation to a social security system or to an universal health coverage (Couverture Maladie Universelle, CMU)
You likely can't join if
- Pregnancy
- Expected death or withdrawal of life-sustaining treatments within 48 hours
- Previously enrolled in this study or in an other interventional study
- Formal indication for corticosteroids according to most recent international guidelines
- Vaccination with live virus within past 6 months
- Hypersensitivity to hydrocortisone or fludrocortisone or (microsined betamethasone dipropionate*) or any of their excipients (SPC)
See the full eligibility criteria
- Patients ≥ 18 years old
- Admitted to the ICU with proven or suspected infection as the main diagnosis
- Community acquired pneumonia related sepsis OR vasopressors dependency (norepinephrine, epinephrine, vasopressin, dopamine, phenylephrine) OR septic shock (Singer 2016: vasopressor to maintain mean blood pressure of at least 65 mmHg and lactate levels above 2 mmol/l) OR acute respiratory distress syndrome (ARDS – Ranieri 2012: a- acute onset, i.e. within one week of an apparent clinical insult and with progression of respiratory syndrome, b- bilateral opacities on chest imaging not explained by other pulmonary pathologies, e.g. pleural effusion, atelectasis, nodules etc, c- no evidence for heart failure or volume overload, d- PaO2/FiO2 ≤ 300 mm Hg, - PEEP ≥ 5 cm H2O
- Patient who has signed an informed and written consent whevener he/she is able of consent, if not ascent from his/her representant whenever he/she is present at time of screening for inclusion
- Patients who have been tested for one or more RECORDS specific biomarkers : o CIRCI o Endocan o GILZ o DUSP-1 o MDW o lymphopenia o Transcriptomic SRS2 o Endotype B o PCR COVID19 o PCR Influenza o PCR other respiratory virus o Cutaneous vasoconstrictor response to glucocorticoids o PCR NFKB1-GLCCI1 o Nucleosome
- Affiliation to a social security system or to an universal health coverage (Couverture Maladie Universelle, CMU)
- Patients under guardianship or curatorship will be included
- Patients in case of simple emergency (legal definition) will be included
- Patients managed with covid 19 and having biological samples available
- Pregnancy
- Expected death or withdrawal of life-sustaining treatments within 48 hours
- Previously enrolled in this study or in an other interventional study
- Formal indication for corticosteroids according to most recent international guidelines
- Vaccination with live virus within past 6 months
- Hypersensitivity to hydrocortisone or fludrocortisone or (microsined betamethasone dipropionate*) or any of their excipients (SPC)
- Women of childbearing potential not using contraception
- Nursing women
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.