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| Name | Class |
|---|---|
| Institut National de la Santé Et de la Recherche Médicale, France | OTHER_GOV |
| University Hospital, Tours | OTHER |
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Comparing the production of interleukin 6 (inflammatory cytokine) in two heating speed (slow rewarming rate: 0.25 ° C / h or fast rewarming rate 0.50 ° C / h) at the completion of a period of targeted temperature at 33°C after cardiac arrest supported by shockable rhythm and successfully resuscitated.
Cardiac arrest (CA) is at present a major cause of mortality as well as a cause of disability for the surviving victims. In France, every year counts as 50,000 cardiac arrests responsible for 40 000 deaths. Thus, less than 20% of patients with heart failure discharged home. Then these patients had impaired quality of life associated with symptoms of fatigue, stress, anxiety hindering the resumption of business activity including. The prognosis is related in part to the initial cardiac rhythm present at the establishment of specialized resuscitation.
Recent progress in improving mortality and neurological outcome has been achieved over the last decade with systematic implementation of a period of targeted temperature management between 32 and 34 ° C (TTM 32-34) in patients with cardiac arrest and who benefited from the completion of at least one external electrical shock when help arrived. The mechanisms underlying this improvement of neurological prognosis are many, but mainly related to an attenuation of post resuscitation syndrome that combines in one hand an inflammatory response (mediated by pro-inflammatory cytokines including interleukin 6) and secondly the formation of reperfusion injury related to the production of radical oxygen species (free radicals).
While some studies have shown the feasibility of induction of this TTM 32-34 in prehospital conditions, no prospective study has evaluated the significant speed of warming in the end. An observational study in which the heating was carried passively, found that patients with an extended heating period (600 minutes) had a worse neurological outcome than patients with a duration of shorter warming (479 minutes) while a second retrospective study concluded the opposite in case of active warming . Besides the fact that these studies were observational, in the two originals randomized studies on TTM 32-34 in CA, the rate of warming was not like:
In this context, investigators propose to conduct a randomized, single-center pilot study comparing a fast warming in a slow warming when performing a TTM 33 patients presented with a shockable cardiac arrest.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low speed of rewarming | Experimental | Patients will be placed in targeted temperature controlled at 33°C for 24 hours. Then, intervention will be proceeded after randomization: slowly rewarmed (0.25°C/h) to targeted temperature controlled at 37°C for 24 hours. |
|
| Fast speed of rewarming | Experimental | Patients will be placed in targeted temperature controlled at 33°C for 24 hours. hen, intervention will be proceeded after randomization: fastly rewarmed (0.50°C/h) for targeted temperature controlled at 37°C for 24 hours. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low Speed of Rewarming | Procedure | Speed of rewarming will be at 0.25°C/h with specific temperature controlled external device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Serum Il6 Levels Over the 48 Hours Following Achievement of the Thermal Target | Median AUC for serum IL6 levels over time | 48 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean Baptiste Lascarrou, MD | Nantes University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Colin Gwenhael | La Roche-sur-Yon | 85000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34915084 | Background | Pouplet C, Colin G, Guichard E, Reignier J, Le Gouge A, Martin S, Lacherade JC, Lascarrou JB; AfterROSC network. The accuracy of various neuro-prognostication algorithms and the added value of neurofilament light chain dosage for patients resuscitated from shockable cardiac arrest: An ancillary analysis of the ISOCRATE study. Resuscitation. 2022 Feb;171:1-7. doi: 10.1016/j.resuscitation.2021.12.009. Epub 2021 Dec 13. | |
| 34920723 |
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Of 160 patients assessed for eligibility, 102 did not meet inclusion criteria, 58 were included and 50 were randomized
All patients were admitted in medical-surgical ICU at local hospital of La Roche sur Yon, France. and assessed for eligibility between February 12, 2016, and May 15, 2020.
Patients were included at ICU admission. Randomization occurred at the end of the hypothermia maintenance phase, i.e., 18-24 h after reaching 33 °C.
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| ID | Title | Description |
|---|---|---|
| FG000 | Rewarming at 0.5°C/h | Speed of rewarming will be at 0.5°C/h with specific temperature controlled external device |
| FG001 | Rewarming at 0.25°C/h | Speed of rewarming will be at 0.25°C/h with specific temperature controlled external device |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Rewarming at 0.25°C/h | Speed of rewarming will be at 0.25°C/h with specific temperature controlled external device |
| BG001 | Rewarming at 0.50°C/h | Speed of rewarming will be at 0.50°C/h with specific temperature controlled external device |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Changes in Serum Il6 Levels Over the 48 Hours Following Achievement of the Thermal Target | Median AUC for serum IL6 levels over time | One patient died between H32 and H40 and was not included in this analysis given the absence of data for the H40 and H48 time points. | Posted | Median | Inter-Quartile Range | pg/mL*h | 48 hours |
|
Adverse events were not collected
Adverse events were not collected
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Rewarming at 0.25°C/h | Speed of rewarming will be at 0.25°C/h with specific temperature controlled external device |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jean-Baptiste Lascarrou | CHU Nantes | +33251446572 | jeanbaptiste.lascarrou@chu-nantes.fr |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 7, 2020 | May 7, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| D007035 | Hypothermia |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
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| High Speed of Rewarming | Procedure | Speed of rewarming will be at 0.50°C/h with specific temperature controlled external device |
|
| Result |
| Lascarrou JB, Guichard E, Reignier J, Le Gouge A, Pouplet C, Martin S, Lacherade JC, Colin G; AfterROSC network. Impact of rewarming rate on interleukin-6 levels in patients with shockable cardiac arrest receiving targeted temperature management at 33 degrees C: the ISOCRATE pilot randomized controlled trial. Crit Care. 2021 Dec 17;25(1):434. doi: 10.1186/s13054-021-03842-9. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Data not collected in the study | Data not collected | Count of Participants | Participants |
|
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Rewarming at 0.50°C/h | Speed of rewarming will be at 0.50°C/h with specific temperature controlled external device | 0 | 0 | 0 | 0 | 0 | 0 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| Unknown or Not Reported |
|