- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04280497
Rapid Recognition of Corticosteroid Resistant or Sensitive Sepsis (RECORDS)
A Multicentre Concealed-Allocation Multi-arms Blinded Randomized Controlled Trial to Identify the Best Sepsis Population for Corticotherapy
Main objective and primary endpoint: 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.
Secondary objectives and endpoints:
- Mortality and health-related quality of life at 6 months;
- Daily organ function (SOFA score days 1, 2, 3, 4, 7, 10, 14, 28, and 90);
- Daily secondary infections (up to 90 days)
- Daily blood and urinary levels of glucose, sodium and potassium (up to 28 day)
- Daily gastroduodenal bleeding (up to 28 day)
- Daily cognitive function and muscles' strength (days 1 to 28, 90 and 180 days).
Study Overview
Detailed Description
The potential benefits of a lower dose ( ≤ 400 mg of hydrocortisone or equivalent per day), and a longer duration at full dose ( ≥ three days) of treatment, have been investigated in numerous randomized controlled trials over the past three decades. In the past two years, guidelines for clinical practices about corticosteroids use in sepsis have been released. All but one of the guidelines, recommended against the use of corticosteroids in sepsis, except in patients with septic shock and poorly responsive to fluid replacement and vasopressor therapy. Some guidelines suggested that corticosteroids should be given as a continuous infusion rather than intermittent boluses.
Corticosteroids survival benefit is not affected by age, gender, disease severity, type of infection, source of infection, or type of pathogens. There is currently no diagnostic test for CS sensitivity/resistance in sepsis. The scientific community is competing to identify markers delineating between patients who draw survival benefit from corticosteroids (CS-sensitive sepsis) and those who may be harmed (CS-resistant sepsis). In sepsis, the deregulated response may result in systemic inflammation and organs damage, or immune paresis and secondary infections. Obviously, patients with systemic inflammation may benefit from CS whereas those with immune paresis may deteriorate. The study team had have looked for an interaction between survival in response to corticosteroids and the presence of CIRCI according to the ACTH test results (cortisol increment of less than 9µg/dL). The benefits from corticosteroids were more important in patients with CIRCI in the Ger-Inf-05 trial but not in the APROCCHS trial. Thus, current sepsis guidelines suggest that the ACTH test may not reliably guide the use of corticosteroids. Indeed, this test provides information neither on corticosteroids bioactivity nor on patient's immune status, when this information should precede any corticotherapy. Recent studies suggested that a transcriptomic signature based on 100 genes may identify a subset of paediatric sepsis that had increased risk of death when exposed to corticosteroids. Another study found transcriptomic based sepsis response signatures (SRS) associated with immune paresis (SRS1) or with systemic inflammation (SRS 2). In this study, patients with a SRS 2 transcriptomic signature had significantly higher mortality when treated with hydrocortisone. Thus, we have started exploring the mechanisms of sensitivity/resistance to corticosteroids in sepsis, namely by investigating endocan, as a surrogate of patient's inflammatory status, and GILZ expression as a marker of corticosteroids bioactivity.
This is a new multicentre concealed-allocation multi-arms, parallel-group, adaptive blinded randomized controlled trial. The overall objective of the trial is to determine whether different signatures of immune status and/or corticosteroids biological activity influence the responses to hydrocortisone plus fludrocortisone of adults with sepsis. To remain pragmatic, this trial has broad eligibility criteria and includes all patients admitted to the ICU with a primary diagnosis of sepsis. Patients will be randomly assigned to hydrocortisone plus fludrocortisone or placebo for 7 days, targeting 1800 patients with full follow-up up to 6 months.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Djillali ANNANE, MD, PhD
- Phone Number: +33 1 47 10 77 87
- Email: djillali.annane@aphp.fr
Study Locations
-
-
Hauts-de-Seine
-
Garches, Hauts-de-Seine, France, 92380
- Recruiting
- Department of medical and surgical Intensive Care Unit, Raymond Poincaré Hospital - APHP
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patient ≥18 years old;
- Admitted to 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 (vasopressor to maintain mean blood pressure of at least 65 mmHg and lactate levels above 2 mmol/l) or acute respiratory distress syndrome (ARDS: 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;
Patients who have been tested for one or more RECORDS specific biomarkers:
- CIRCI
- Endocan
- GILZ
- DUSP-1
- MDW
- lymphopenia
- Transcriptomic SRS2
- Endotype B
- PCR COVID-19
- PCR Influenza
- PCR other respiratory virus
- Cutaneous vasoconstrictor response to glucocorticoids
- Patient who has signed an informed and written consent whevener he/she is able of consent, if not, if not ascent from his/her representant whenever he/she is present at time of screening for inclusion;
- Patient affiliated to a social security system or to an universal health coverage (Couverture Maladie Universelle (CMU) in France;
- Patient under guardianship or curatorship will be included;
- Patient in case of simple emergency (legal definition) will be included;
- Patients managed with covid 19 and having biological samples available.
Exclusion Criteria:
- Pregnancy;
- Expected death or withdrawal of life-sustaining treatments within 48 hours;
- Previously enrolled in this 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 * For patients included in this stratum, if applicable, do not apply the cream to an infected or ulcerated area
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Biomarker CIRCI neg: Corticosteroid arm
Hydrocortisone plus fludrocortisone as treatment: hydrocortisone hemisuccinate and 9 alpha fludrocortisone as experimental treatment.
|
Hydrocortisone hemisuccinate / hydrocortisone placebo will be given as 50 mg intravenous bolus every 6 hours; 9 alpha fludrocortisone / 9 alpha fludrocortisone placebo will be given as a 50 μg tablet via a nasogastric tube once per day in the morning. Study drugs will be started immediately after randomization (day 0 of the study), until discharge from ICU for a maximal duration of 7 days. Study drugs will be stopped without tapering off. |
Placebo Comparator: Biomarker CIRCI neg: Placebo arm
Placebo: hydrocortisone placebo and 9 alpha fludrocortisone placebo as placebo treatment.
|
Hydrocortisone hemisuccinate / hydrocortisone placebo will be given as 50 mg intravenous bolus every 6 hours; 9 alpha fludrocortisone / 9 alpha fludrocortisone placebo will be given as a 50 μg tablet via a nasogastric tube once per day in the morning. Study drugs will be started immediately after randomization (day 0 of the study), until discharge from ICU for a maximal duration of 7 days. Study drugs will be stopped without tapering off. |
Experimental: Biomarker endocan: Corticosteroid arm
Hydrocortisone plus fludrocortisone as treatment: hydrocortisone hemisuccinate and 9 alpha fludrocortisone as experimental treatment.
|
Hydrocortisone hemisuccinate / hydrocortisone placebo will be given as 50 mg intravenous bolus every 6 hours; 9 alpha fludrocortisone / 9 alpha fludrocortisone placebo will be given as a 50 μg tablet via a nasogastric tube once per day in the morning. Study drugs will be started immediately after randomization (day 0 of the study), until discharge from ICU for a maximal duration of 7 days. Study drugs will be stopped without tapering off. |
Placebo Comparator: Biomarker endocan: Placebo arm
Placebo: hydrocortisone placebo and 9 alpha fludrocortisone placebo as placebo treatment.
|
Hydrocortisone hemisuccinate / hydrocortisone placebo will be given as 50 mg intravenous bolus every 6 hours; 9 alpha fludrocortisone / 9 alpha fludrocortisone placebo will be given as a 50 μg tablet via a nasogastric tube once per day in the morning. Study drugs will be started immediately after randomization (day 0 of the study), until discharge from ICU for a maximal duration of 7 days. Study drugs will be stopped without tapering off. |
Experimental: Biomarker GILZ: Corticosteroid arm
Hydrocortisone plus fludrocortisone as treatment: hydrocortisone hemisuccinate and 9 alpha fludrocortisone as experimental treatment.
|
Hydrocortisone hemisuccinate / hydrocortisone placebo will be given as 50 mg intravenous bolus every 6 hours; 9 alpha fludrocortisone / 9 alpha fludrocortisone placebo will be given as a 50 μg tablet via a nasogastric tube once per day in the morning. Study drugs will be started immediately after randomization (day 0 of the study), until discharge from ICU for a maximal duration of 7 days. Study drugs will be stopped without tapering off. |
Placebo Comparator: Biomarker GILZ: Placebo arm
Placebo: hydrocortisone placebo and 9 alpha fludrocortisone placebo as placebo treatment.
|
Hydrocortisone hemisuccinate / hydrocortisone placebo will be given as 50 mg intravenous bolus every 6 hours; 9 alpha fludrocortisone / 9 alpha fludrocortisone placebo will be given as a 50 μg tablet via a nasogastric tube once per day in the morning. Study drugs will be started immediately after randomization (day 0 of the study), until discharge from ICU for a maximal duration of 7 days. Study drugs will be stopped without tapering off. |
Experimental: Biomarker CPD: Corticosteroid arm
Hydrocortisone plus fludrocortisone as treatment: hydrocortisone hemisuccinate and 9 alpha fludrocortisone as experimental treatment.
|
Hydrocortisone hemisuccinate / hydrocortisone placebo will be given as 50 mg intravenous bolus every 6 hours; 9 alpha fludrocortisone / 9 alpha fludrocortisone placebo will be given as a 50 μg tablet via a nasogastric tube once per day in the morning. Study drugs will be started immediately after randomization (day 0 of the study), until discharge from ICU for a maximal duration of 7 days. Study drugs will be stopped without tapering off. |
Placebo Comparator: Biomarker CPD: Placebo arm
Placebo: hydrocortisone placebo and 9 alpha fludrocortisone placebo as placebo treatment.
|
Hydrocortisone hemisuccinate / hydrocortisone placebo will be given as 50 mg intravenous bolus every 6 hours; 9 alpha fludrocortisone / 9 alpha fludrocortisone placebo will be given as a 50 μg tablet via a nasogastric tube once per day in the morning. Study drugs will be started immediately after randomization (day 0 of the study), until discharge from ICU for a maximal duration of 7 days. Study drugs will be stopped without tapering off. |
Experimental: Biomarker Transcriptomic SRS: Corticosteroid arm
Hydrocortisone plus fludrocortisone as treatment: hydrocortisone hemisuccinate and 9 alpha fludrocortisone as experimental treatment.
|
Hydrocortisone hemisuccinate / hydrocortisone placebo will be given as 50 mg intravenous bolus every 6 hours; 9 alpha fludrocortisone / 9 alpha fludrocortisone placebo will be given as a 50 μg tablet via a nasogastric tube once per day in the morning. Study drugs will be started immediately after randomization (day 0 of the study), until discharge from ICU for a maximal duration of 7 days. Study drugs will be stopped without tapering off. |
Placebo Comparator: Biomarker Transcriptomic SRS: Placebo arm
Placebo: hydrocortisone placebo and 9 alpha fludrocortisone placebo as placebo treatment.
|
Hydrocortisone hemisuccinate / hydrocortisone placebo will be given as 50 mg intravenous bolus every 6 hours; 9 alpha fludrocortisone / 9 alpha fludrocortisone placebo will be given as a 50 μg tablet via a nasogastric tube once per day in the morning. Study drugs will be started immediately after randomization (day 0 of the study), until discharge from ICU for a maximal duration of 7 days. Study drugs will be stopped without tapering off. |
Experimental: Biomarker Endotype B: Corticosteroid arm
Hydrocortisone plus fludrocortisone as treatment: hydrocortisone hemisuccinate and 9 alpha fludrocortisone as experimental treatment.
|
Hydrocortisone hemisuccinate / hydrocortisone placebo will be given as 50 mg intravenous bolus every 6 hours; 9 alpha fludrocortisone / 9 alpha fludrocortisone placebo will be given as a 50 μg tablet via a nasogastric tube once per day in the morning. Study drugs will be started immediately after randomization (day 0 of the study), until discharge from ICU for a maximal duration of 7 days. Study drugs will be stopped without tapering off. |
Placebo Comparator: Biomarker Endotype B: Placebo arm
Placebo: hydrocortisone placebo and 9 alpha fludrocortisone placebo as placebo treatment.
|
Hydrocortisone hemisuccinate / hydrocortisone placebo will be given as 50 mg intravenous bolus every 6 hours; 9 alpha fludrocortisone / 9 alpha fludrocortisone placebo will be given as a 50 μg tablet via a nasogastric tube once per day in the morning. Study drugs will be started immediately after randomization (day 0 of the study), until discharge from ICU for a maximal duration of 7 days. Study drugs will be stopped without tapering off. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
3-month mortality
Time Frame: Daily up to 3 months
|
Patient's vital status.
|
Daily up to 3 months
|
Persistent organ dysfunction
Time Frame: At baseline, 1 month and 3 months
|
Persistent organ dysfunction (defined as continued dependency on mechanical ventilation, renal replacement therapy, or vasopressors) and with SOFA score ≤6 up to 90 days.
|
At baseline, 1 month and 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mortality at 7, 14, 28 day and 6 months
Time Frame: at 7, 14, 28 day and 6 months
|
Patient's vital status.
|
at 7, 14, 28 day and 6 months
|
Vasopressor free days
Time Frame: through study completion, an average of 6 month
|
defined as the number of days with permanent hemodynamic stability in the absence of any vasopressor agent, norepinephrine, phenylephrine, epinephrine, dopamine, vasopressine or its analogs, and soever.
When a patient will die on vasopressor therapy, the corresponding vasopressor free day will be 0.
|
through study completion, an average of 6 month
|
Mechanical ventilation free days
Time Frame: through study completion, an average of 6 month
|
defined as the number of days with permanent appropriate oxygenation while the patients is extubated and breathing spontaneously, i.e. no need for non invasive ventilation, high flow oxygen or CPAP.
Other uses of non-invasive ventilation (e.g., chronic night-time use for chronic obstructive pulmonary disease) are not counted.
When a patient will die on mechanical ventilation or will be discharge home on mechanical ventilation, the corresponding mechanical ventilation free day will be 0.
|
through study completion, an average of 6 month
|
Organ dysfunction free days
Time Frame: through study completion, an average of 6 month
|
Organ function (including renal function) will be assessed by the SOFA score (Vincent 1996).
Organ dysfunction will be defined by a SOFA score of > 6 (Annane 2018).
Organ dysfunction free days are defined by the number of days with os total SOFA score of 6 or less.
When a patient will die on vasopressor therapy, the corresponding vasopressor free day will be 0.
|
through study completion, an average of 6 month
|
HRQoL in 6-month survivors assessed by the EuroQol-5D (EQ-5D)
Time Frame: at 1, 28, 90 day and 6 months
|
This questionnaire is a standardised measure of health status developed to provide a simple, generic measure of health for clinical and economic appraisal.
It is made up for two components; health state description and evaluation.
The health status is measured in terms of five dimensions; mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
In evaluation part, the respondents evaluate their overall health status using the visual analogue scale.
|
at 1, 28, 90 day and 6 months
|
Proportion of patients with a decision to withhold and/or withdraw active treatments
Time Frame: through study completion, an average of 6 month
|
through study completion, an average of 6 month
|
|
ICU and hospital length of stay
Time Frame: through study completion, an average of 6 month
|
through study completion, an average of 6 month
|
|
Rate of re-admission to the ICU during the 180 days after randomization
Time Frame: through study completion, an average of 6 month
|
through study completion, an average of 6 month
|
|
Safety endpoints: proportion of patients affected by any serious adverse events
Time Frame: up to 90 days
|
Serious adverse events associated with corticosteroids, among the following: hospital-acquired infections, hyperglycemia, hypernatremia, neurological disorders (coma, stroke or muscle weakness, as defined below) during the 90 days after randomization.
|
up to 90 days
|
Coma
Time Frame: up to 90 days
|
Coma will be defined as a Glasgow coma score < 8
|
up to 90 days
|
Neurologic sequelae
Time Frame: up to 90 days
|
Neurologic sequelae will be assessed according to the score on the Muscular Disability Rating Scale (MDRS), with a score of 1 indicating no deficit, 2 minor deficit with no functional disability, 3 distal motor deficit, 4 mild-to-moderate proximal motor deficit, and 5 severe proximal motor deficit.
|
up to 90 days
|
Proportion of patients affected by hospital-acquired infections
Time Frame: up to 90 days
|
Proportion of patients affected by hospital-acquired infections (CTINILS.
Définition des infections associées aux soins.
2007, (document in french)).
|
up to 90 days
|
Number of episodes of hyperglycemia
Time Frame: daily during ICU stay or up to 90 days
|
Number of episodes of hyperglycemia (blood glucose levels >150mg/dl) during ICU stay (or up to day 90, whichever occurs first)
|
daily during ICU stay or up to 90 days
|
Number of episodes of hypernatremia
Time Frame: daily during ICU stay or up to day 90
|
Number of episodes of hypernatremia (serum sodium > 145 mmol/L) during ICU stay (or up to day 90, whichever occurs first)
|
daily during ICU stay or up to day 90
|
Glasgow coma scale at ICU and hospital discharge
Time Frame: at ICU discharge and hospital discharge
|
Glasgow coma scale at ICU and hospital discharge
|
at ICU discharge and hospital discharge
|
Number of patients with an episode of stroke
Time Frame: daily during ICU stay or up to day 90
|
Number of patients with an episode of stroke (medical diagnosis as registered in the medical file) during ICU stay (or up to day 90, whichever occurs first)
|
daily during ICU stay or up to day 90
|
Gastroduodenal bleeding
Time Frame: daily during ICU stay or up to day 90
|
Gastroduodenal bleeding requiring transfusion or hemostatic treatment during ICU stay (or up to day 90, whichever occurs first)
|
daily during ICU stay or up to day 90
|
Adult cognitive function score
Time Frame: at 1, 28, 90 day and 6 months
|
Neurological cognitive dysfunction defined as by low score on the PROMIS (Adult cognitive function score). PROMIS (Patient-Reported Outcomes Measurement Information System): for assessment of fatigue, ability to partake in social activities, physical function, emotional distress, depression, anxiety and cognitive function. |
at 1, 28, 90 day and 6 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Djillali ANNANE, MD, PhD, Department of medical and surgical Intensive Care Unit, - Raymond Poincaré Hospital - APHP
Publications and helpful links
General Publications
- Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.
- Rhodes A, Evans LE, Alhazzani W, Levy MM, Antonelli M, Ferrer R, Kumar A, Sevransky JE, Sprung CL, Nunnally ME, Rochwerg B, Rubenfeld GD, Angus DC, Annane D, Beale RJ, Bellinghan GJ, Bernard GR, Chiche JD, Coopersmith C, De Backer DP, French CJ, Fujishima S, Gerlach H, Hidalgo JL, Hollenberg SM, Jones AE, Karnad DR, Kleinpell RM, Koh Y, Lisboa TC, Machado FR, Marini JJ, Marshall JC, Mazuski JE, McIntyre LA, McLean AS, Mehta S, Moreno RP, Myburgh J, Navalesi P, Nishida O, Osborn TM, Perner A, Plunkett CM, Ranieri M, Schorr CA, Seckel MA, Seymour CW, Shieh L, Shukri KA, Simpson SQ, Singer M, Thompson BT, Townsend SR, Van der Poll T, Vincent JL, Wiersinga WJ, Zimmerman JL, Dellinger RP. Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock: 2016. Intensive Care Med. 2017 Mar;43(3):304-377. doi: 10.1007/s00134-017-4683-6. Epub 2017 Jan 18.
- Annane D, Pastores SM, Rochwerg B, Arlt W, Balk RA, Beishuizen A, Briegel J, Carcillo J, Christ-Crain M, Cooper MS, Marik PE, Umberto Meduri G, Olsen KM, Rodgers S, Russell JA, Van den Berghe G. Guidelines for the diagnosis and management of critical illness-related corticosteroid insufficiency (CIRCI) in critically ill patients (Part I): Society of Critical Care Medicine (SCCM) and European Society of Intensive Care Medicine (ESICM) 2017. Intensive Care Med. 2017 Dec;43(12):1751-1763. doi: 10.1007/s00134-017-4919-5. Epub 2017 Sep 21. Erratum In: Intensive Care Med. 2018 Feb 23;:
- Lamontagne F, Rochwerg B, Lytvyn L, Guyatt GH, Moller MH, Annane D, Kho ME, Adhikari NKJ, Machado F, Vandvik PO, Dodek P, Leboeuf R, Briel M, Hashmi M, Camsooksai J, Shankar-Hari M, Baraki MK, Fugate K, Chua S, Marti C, Cohen D, Botton E, Agoritsas T, Siemieniuk RAC. Corticosteroid therapy for sepsis: a clinical practice guideline. BMJ. 2018 Aug 10;362:k3284. doi: 10.1136/bmj.k3284. No abstract available.
- Rochwerg B, Oczkowski SJ, Siemieniuk RAC, Agoritsas T, Belley-Cote E, D'Aragon F, Duan E, English S, Gossack-Keenan K, Alghuroba M, Szczeklik W, Menon K, Alhazzani W, Sevransky J, Vandvik PO, Annane D, Guyatt G. Corticosteroids in Sepsis: An Updated Systematic Review and Meta-Analysis. Crit Care Med. 2018 Sep;46(9):1411-1420. doi: 10.1097/CCM.0000000000003262.
- Nishida O, Ogura H, Egi M, Fujishima S, Hayashi Y, Iba T, Imaizumi H, Inoue S, Kakihana Y, Kotani J, Kushimoto S, Masuda Y, Matsuda N, Matsushima A, Nakada TA, Nakagawa S, Nunomiya S, Sadahiro T, Shime N, Yatabe T, Hara Y, Hayashida K, Kondo Y, Sumi Y, Yasuda H, Aoyama K, Azuhata T, Doi K, Doi M, Fujimura N, Fuke R, Fukuda T, Goto K, Hasegawa R, Hashimoto S, Hatakeyama J, Hayakawa M, Hifumi T, Higashibeppu N, Hirai K, Hirose T, Ide K, Kaizuka Y, Kan'o T, Kawasaki T, Kuroda H, Matsuda A, Matsumoto S, Nagae M, Onodera M, Ohnuma T, Oshima K, Saito N, Sakamoto S, Sakuraya M, Sasano M, Sato N, Sawamura A, Shimizu K, Shirai K, Takei T, Takeuchi M, Takimoto K, Taniguchi T, Tatsumi H, Tsuruta R, Yama N, Yamakawa K, Yamashita C, Yamashita K, Yoshida T, Tanaka H, Oda S. The Japanese Clinical Practice Guidelines for Management of Sepsis and Septic Shock 2016 (J-SSCG 2016). Acute Med Surg. 2018 Feb 5;5(1):3-89. doi: 10.1002/ams2.322. eCollection 2018 Jan.
- Tavare A, O'Flynn N. Recognition, diagnosis, and early management of sepsis: NICE guideline. Br J Gen Pract. 2017 Apr;67(657):185-186. doi: 10.3399/bjgp17X690401. No abstract available.
- van der Poll T, van de Veerdonk FL, Scicluna BP, Netea MG. The immunopathology of sepsis and potential therapeutic targets. Nat Rev Immunol. 2017 Jul;17(7):407-420. doi: 10.1038/nri.2017.36. Epub 2017 Apr 24.
- Wong HR, Cvijanovich NZ, Anas N, Allen GL, Thomas NJ, Bigham MT, Weiss SL, Fitzgerald J, Checchia PA, Meyer K, Shanley TP, Quasney M, Hall M, Gedeit R, Freishtat RJ, Nowak J, Shekhar RS, Gertz S, Dawson E, Howard K, Harmon K, Beckman E, Frank E, Lindsell CJ. Developing a clinically feasible personalized medicine approach to pediatric septic shock. Am J Respir Crit Care Med. 2015 Feb 1;191(3):309-15. doi: 10.1164/rccm.201410-1864OC.
- Antcliffe DB, Burnham KL, Al-Beidh F, Santhakumaran S, Brett SJ, Hinds CJ, Ashby D, Knight JC, Gordon AC. Transcriptomic Signatures in Sepsis and a Differential Response to Steroids. From the VANISH Randomized Trial. Am J Respir Crit Care Med. 2019 Apr 15;199(8):980-986. doi: 10.1164/rccm.201807-1419OC. Erratum In: Am J Respir Crit Care Med. 2022 Dec 15;206(12):1572-1573.
- Annane D, Pastores SM, Arlt W, Balk RA, Beishuizen A, Briegel J, Carcillo J, Christ-Crain M, Cooper MS, Marik PE, Meduri GU, Olsen KM, Rochwerg B, Rodgers SC, Russell JA, Van den Berghe G. Critical illness-related corticosteroid insufficiency (CIRCI): a narrative review from a Multispecialty Task Force of the Society of Critical Care Medicine (SCCM) and the European Society of Intensive Care Medicine (ESICM). Intensive Care Med. 2017 Dec;43(12):1781-1792. doi: 10.1007/s00134-017-4914-x. Epub 2017 Sep 21.
- ARDS Definition Task Force; Ranieri VM, Rubenfeld GD, Thompson BT, Ferguson ND, Caldwell E, Fan E, Camporota L, Slutsky AS. Acute respiratory distress syndrome: the Berlin Definition. JAMA. 2012 Jun 20;307(23):2526-33. doi: 10.1001/jama.2012.5669.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- APHP191110
- 2020-000296-21 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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VA Office of Research and DevelopmentAugusta UniversityNot yet recruitingAge-related Macular Degeneration (AMD)United States
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Rochester General HospitalActive, not recruitingNasopharyngeal Colonization and Acute Otitis MediaUnited States
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Fondazione GISE OnlusUniversity of Padova; Shockwave Medical, Inc.; INNOVA HTS SRLRecruitingCoronary DiseaseItaly
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University of Roma La SapienzaAzienda Ospedaliera Città della Salute e della Scienza di Torino; IRCCS Azienda... and other collaboratorsUnknownPneumonia, Viral | Covid19 | Obesity, Morbid | Complication of Surgical Procedure | Bariatric Surgery Candidate | Safety Issues | Readmission | Viral InfectionItaly
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Medtronic - MITGCompletedChronic Inflammatory Small Bowel DiseaseIsrael
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National Center for Occupational Health and Infection...VA Office of Research and DevelopmentCompletedTolerability | ComfortUnited States
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University of Sao Paulo General HospitalRecruitingSARS-CoV2 Infection | Viral Load | Oral Diseases | Dental TreatmentBrazil
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Prof.dr. E.G.E. de VriesRecruitingMelanoma | Non-Small Cell Lung CancerNetherlands