Trial Outcomes & Findings for Impact of Speed Of Rewarming After CaRdiac Arrest and ThErapeutic Hypothermia (NCT NCT02555254)

NCT ID: NCT02555254

Last Updated: 2025-12-02

Results Overview

Median AUC for serum IL6 levels over time

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 58 participants
• Primary outcome timeframe: 48 hours
• Results posted on: 2025-12-02

Participant Flow

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.

Of 160 patients assessed for eligibility, 102 did not meet inclusion criteria, 58 were included and 50 were randomized

Participant milestones

Measure	Rewarming at 0.5°C/h Speed of rewarming will be at 0.5°C/h with specific temperature controlled external device	Rewarming at 0.25°C/h Speed of rewarming will be at 0.25°C/h with specific temperature controlled external device
Overall Study STARTED	25	25
Overall Study COMPLETED	25	25
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Data not collected

Baseline characteristics by cohort

Measure	Rewarming at 0.25°C/h n=25 Participants Speed of rewarming will be at 0.25°C/h with specific temperature controlled external device	Rewarming at 0.50°C/h n=25 Participants Speed of rewarming will be at 0.50°C/h with specific temperature controlled external device	Total n=50 Participants Total of all reporting groups
Age, Continuous	66.2 years n=25 Participants	53.8 years n=25 Participants	61 years n=50 Participants
Sex: Female, Male Female	4 Participants n=25 Participants	5 Participants n=25 Participants	9 Participants n=50 Participants
Sex: Female, Male Male	21 Participants n=25 Participants	20 Participants n=25 Participants	41 Participants n=50 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants Data not collected	0 Participants Data not collected	0 Participants Data not collected
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants Data not collected	0 Participants Data not collected	0 Participants Data not collected
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants Data not collected	0 Participants Data not collected	0 Participants Data not collected

PRIMARY outcome

Timeframe: 48 hours

Population: 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.

Median AUC for serum IL6 levels over time

Outcome measures

Measure	Rewarming at 0.25°C/h n=24 Participants Speed of rewarming will be at 0.25°C/h with specific temperature controlled external device	Rewarming at 0.50°C/h n=25 Participants Speed of rewarming will be at 0.50°C/h with specific temperature controlled external device
Changes in Serum Il6 Levels Over the 48 Hours Following Achievement of the Thermal Target	12389 pg/mL*h Interval 7256.0 to 37200.0	8859 pg/mL*h Interval 6825.0 to 18088.0

Adverse Events

Rewarming at 0.25°C/h

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Rewarming at 0.50°C/h

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jean-Baptiste Lascarrou

CHU Nantes

Phone: +33251446572

Email: jeanbaptiste.lascarrou@chu-nantes.fr

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place