Bernard 2002.
| Study characteristics | |
| Methods | Study type: RCT Aim of the study: efficacy Participating sites: 4 university and community hospitals in Melbourne, Australia Language: English Start date, end date: September 1996 to June 1999 |
| Participants | Number randomised: 43 (intervention); 34 (control) Inclusion criteria: an initial cardiac rhythm of VF at time of arrival of the ambulance, successful ROSC, persistent coma after the ROSC and transfer to 1 of 4 participating emergency departments Exclusion criteria: non‐cardiac causes including trauma, drowning, hanging and intoxication; predicted death within 72 hours; contraindications to TTM including haemorrhage, fatal arrhythmia and sepsis; baseline CPC score 3; presence of an advanced directive to withhold or withdraw life‐sustaining treatment or lack of informed consent Mean/median age: 66 years Women: 33% Cardiac arrest location: out‐of‐hospital Cause of cardiac arrest: any Primary cardiac rhythm: VF Witnessed cardiac arrest: 95% Bystander CPR: 59% Timing cardiac arrest (out‐of‐hospital cardiac arrest) (minutes):
Temperature on admission/at start of cooling: 35 °C (intervention); 35.5 °C (control) Subgroups reported: none |
| Interventions | Prehospital cooling: yes, 56% Target temperature intervention: 33 °C Duration of TTM: 12 hours Was intervention initiated within 2 hours of ROSC? yes Was target temperature reached within 4 hours of ROSC? yes Co‐interventions? yes Description of control group management: target core temperature 37 °C. Passive rewarming used in these participants if there was mild spontaneous hypothermia on arrival. Cooling rates: n.i. Was rewarming controlled? yes Rewarming: passive after 12 hours, active after 18 hours |
| Outcomes | Survival with good neurological function to be sent home or to a rehabilitation facility at discharge In‐hospital death Haemodynamic, biochemical and haematological effects of hypothermia Best ever reached CPC during hospital stay and CPC discharge was provided by the investigators. |
| Control group treatment | Target core temperature 37 °C. Passive rewarming used in these participants if there was mild spontaneous hypothermia on arrival. |
| Funding source | |
| Notes | Randomisation: odd and even days |