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the H1N1 pandemic is now over, and fewer cases than expected were observed
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| Name | Class |
|---|---|
| Assistance Publique - Hôpitaux de Paris | OTHER |
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The H1N1 flu pandemic is one of the major infectious threat of the past half century. it is rapidly progressing worldwide and a substantial number of patients get severe H1N1 related pneumonia that requires mechanical ventilation and admission to the intensive care unit. The acute respiratory distress syndrome is associated with a substantial mortality and morbidity partly as a consequence of uncontrolled lung and systemic inflammation. many physicians are trying to counteract this pro-inflammatory storm by the use of corticosteroids albeit these drugs may cause super infection or metabolic disorders. Thus, there is a need for a randomized double blind, placebo controlled trial to define the benefit to risk ratio of corticosteroids in this patient.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Corticosteroids | Experimental | Hydrocortisone |
|
| Control | Placebo Comparator | isotonic saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hydrocortisone | Drug | 50mg intravenous bolus every 6 hours for one week, then every 12 hours for one week and then every 24 hours for one week |
|
| Measure | Description | Time Frame |
|---|---|---|
| in hospital all cause morality | hospital discharge up to 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| 28 day mortality | 28 day | |
| 90 day all cause mortality | 90 day | |
| 6 month all cause mortality |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Djillali Annane, MD,PhD | AP--HP and University of Versailles SQY | Study Chair |
| Christian Brun Buisson, MD | AP-HP and Paris XII University | Principal Investigator |
| Charles Mayaud | AP-HP and University of Paris VII | Principal Investigator |
| Bernard Régnier | AP-HP and Paris VII University | Principal Investigator |
| Christian Perronne | AP-HP and University of Versailles SQY | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Raymond Poincaré hospital | Garches | 92380 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22120766 | Result | Annane D, Antona M, Lehmann B, Kedzia C, Chevret S; CORTIFLU Investigators; CRICs; AZUREA; REVA/SRLF networks. Designing and conducting a randomized trial for pandemic critical illness: the 2009 H1N1 influenza pandemic. Intensive Care Med. 2012 Jan;38(1):29-39. doi: 10.1007/s00134-011-2409-8. Epub 2011 Nov 26. |
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| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D007251 | Influenza, Human |
| D055371 | Acute Lung Injury |
| D012128 | Respiratory Distress Syndrome |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
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| ID | Term |
|---|---|
| D006854 | Hydrocortisone |
| C021650 | hydrocortisone acetate |
| D012965 | Sodium Chloride |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| isotonic saline | Drug | intravenous bolus every 6 hours for one week, then every 12 hours for one week and then every 24 hours for one week |
|
|
| 180 days |
| mechanical ventilation free days | hospital discharge up to 90 days |
| intensive care unit free days | hospital discharge up to 90 days |
| proportion of patients with secondary infections | hospital discharge up to 90 days |
| proportion of patients who require ECMO | hospital discharge up to 90 days |
| respiratory function and health status | 180 days |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D055370 | Lung Injury |
| D012120 | Respiration Disorders |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D015062 | 11-Hydroxycorticosteroids |
| D006889 | Hydroxycorticosteroids |
| D000305 | Adrenal Cortex Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D015065 | 17-Hydroxycorticosteroids |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |