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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-A02557-32 | Other Identifier | ID-RCB |
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The Dressing-ECMO trial is a prospective, open-label, multicenter, controlled trial randomizing patients who received percutaneous ECMO to cannula chlorhexidine-impregnated dressing vs standard dressing. The study goal is to determine if cannula chlorhexidine-impregnated dressings can reduce the number of cannula major-related infections with or without bloodstream infection
Open-label, multicenter, randomized, controlled trial. This study will be conducted in patients with cardiogenic shock or acute respiratory distress syndrome receiving percutaneous ECMO for less than 24h. All consecutive eligible patients will be proposed to participate. They will be randomly allocated in a 1:1 ratio to conventional cannula dressing, or cannula chlorhexidine-impregnated dressing, using an online, central randomisation service, to ensure allocation concealment. Blocked randomization will be performed using random block size. Randomization will be stratified according to center and ECMO type (i.e veno venous or arteriovenous). In both groups, peripheral blood sample will be cultured daily from first day on ECMO to 48h after ECMO removal, death on ECO or ECMO day 30 whichever occurs first. In case of ECMO cannula infection suspicion, deep samples of the cannula will be cultured according to the usual procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chlorhexidine-impregnated dressings | Experimental |
| |
| Non impregnated dressings | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chlorhexidine-impregnated dressings | Device | Sterile adhesive transparent dressings impregnated with Chlorhexidine Gluconate gel applied to ECMO cannulae for up to 7 consecutive days for each dressing, in the absence of exudation or bleeding at the point of insertion and until explantation of the ECMO, sometimes requiring dressing changes. |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative incidence per 1000 ECMO days of ECMO cannula-related infection episodes, associated or not with bacteremia/fungemia | From ECMO initiation date (baseline) and up to day 60 |
| Measure | Description | Time Frame |
|---|---|---|
| Colonization of ECMO cannulas at Day 7 and weaning from ECMO | Day 7 to 2 days after ECMO weaning date | |
| Number of dressing changes for soiling or detachment | From day 1 to 2 days after ECMO weaning date |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Besançon - Hôpital Jean Minjoz | Besançon | 25000 | France | |||
| CH Sud Francilien |
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|
| Non impregnated dressings | Device | Single transparent adhesive dressings not impregnated with Chlorhexidine Gluconate applied to ECMO cannulae for up to 7 consecutive days for each dressing, in the absence of exudation or bleeding at the point of insertion and until explantation of the ECMO, sometimes requiring dressing changes. |
|
| Number of days alive without antibiotics/fungal agents on ECMO | Between day 1 and Day 60 |
| Total duration of ECMO | Between ECMO initiation date (baseline) and ECMO weaning date |
| Number of day in ICU | Between day 1 and Day 60 |
| Overall survival | Day7, Day 30, Day 60 |
| Cumulative incidence of ECMO cannula-related bacteremia/fungemia | From ECMO initiation date (baseline) and up to day 60 |
| Cumulative incidence of each cannula infection endpoint in both arms | From ECMO initiation date (baseline) and up to day 60 |
| Incidence of contact dermatitis or skin allergy | From ECMO initiation date (baseline) and up to day 60 |
| Corbeil-Essonnes |
| 91100 |
| France |
| Hôpital Henri-Mondor | Créteil | 94000 | France |
| CHRU Nancy - Hôpitaux de Brabois | Nancy | 54500 | France |
| Hôpital Pitié Salpêtrière | Paris | 75013 | France |
| Hôpital Foch | Suresnes | 92150 | France |
| ID | Term |
|---|---|
| D012770 | Shock, Cardiogenic |
| D012128 | Respiratory Distress Syndrome |
| D007239 | Infections |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D012769 | Shock |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
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