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In this trial involving patients after out-of-hospital cardiac arrest, fever prevention for 36 or 72 hours did not result in different percentages of patients dying or having severe disability or coma.

In this study of three strategies — hypothermia, machine perfusion, or both — for pretransplantation preservation of kidneys from brain-dead donors, hypothermia was found to be inferior to machine perfusion.

Background We aimed to investigate the diagnostic performance of S100 as an outcome predictor after out-of-hospital cardiac arrest (OHCA) and the potential influence of two target temperatures (33 °C and 36 °C) on serum levels of S100. Methods This is a substudy of the Target Temperature Management after Out-of-Hospital Cardiac Arrest (TTM) trial. Serum levels of S100 were measured a posteriori in a core laboratory in samples collected at 24, 48, and 72 h after OHCA. Outcome at 6 months was assessed using the Cerebral Performance Categories Scale (CPC 1–2 = good outcome, CPC 3–5 = poor outcome). Results We included 687 patients from 29 sites in Europe. Median S100 values were higher in patients with a poor outcome at 24, 48, and 72 h: 0.19 (IQR 0.10–0.49) versus 0.08 (IQR 0.06–0.11) μg/ml, 0.16 (IQR 0.10–0.44) versus 0.07 (IQR 0.06–0.11) μg/L, and 0.13 (IQR 0.08–0.26) versus 0.06 (IQR 0.05–0.09) μg/L ( p  < 0.001), respectively. The ability to predict outcome was best at 24 h with an AUC of 0.80 (95% CI 0.77–0.83). S100 values were higher at 24 and 72 h in the 33 °C group than in the 36 °C group (0.12 [0.07–0.22] versus 0.10 [0.07–0.21] μg/L and 0.09 [0.06–0.17] versus 0.08 [0.05–0.10], respectively) ( p  < 0.02). In multivariable analyses including baseline variables and the allocated target temperature, the addition of S100 improved the AUC from 0.80 to 0.84 (95% CI 0.81–0.87) ( p  < 0.001), but S100 was not an independent outcome predictor. Adding S100 to the same model including neuron-specific enolase (NSE) did not further improve the AUC. Conclusions The allocated target temperature did not affect S100 to a clinically relevant degree. High S100 values are predictive of poor outcome but do not add value to present prognostication models with or without NSE. S100 measured at 24 h and afterward is of limited value in clinical outcome prediction after OHCA. Trial registration ClinicalTrials.gov identifier: NCT01020916 . Registered on 25 November 2009.

Background To elucidate the incidence of acute kidney injury (AKI) after out-of-hospital cardiac arrest (OHCA) and to examine the impact of target temperature management (TTM) and early coronary angiography on renal function. Methods Post hoc analysis of the TTM trial, a multinational randomised controlled trial comparing target temperature of 33 °C versus 36 °C in patients with return of spontaneous circulation after OHCA. The impact of TTM and early angiography (within 6 h of OHCA) versus late or no angiography on the development of AKI during the 7-day period after OHCA was analysed. AKI was defined according to modified KDIGO criteria in patients surviving beyond day 2 after OHCA. Results Following exclusions, 853 of 939 patients enrolled in the main trial were analysed. Unadjusted analysis showed that significantly more patients in the 33 °C group had AKI compared to the 36 °C group [211/431 (49%) versus 170/422 (40%) p  = 0.01], with a worse severity ( p  = 0.018). After multivariable adjustment, the difference was not significant (odds ratio 0.75, 95% confidence interval 0.54–1.06, p  = 0.10]. Five hundred seventeen patients underwent early coronary angiography. Although the unadjusted analysis showed less AKI and less severe AKI in patients who underwent early angiography compared to patients with late or no angiography, in adjusted analyses, early angiography was not an independent risk factor for AKI (odds ratio 0.73, 95% confidence interval 0.50–1.05, p  = 0.09). Conclusions In OHCA survivors, TTM at 33 °C compared to management at 36 °C did not show different rates of AKI and early angiography was not associated with an increased risk of AKI. Trial registration NCT01020916 . Registered on www.ClinicalTrials.gov 26 November 2009 (main trial).

On the basis of mixed results from previous trials, we assessed whether therapeutic hypothermia for 48–72 h with slow rewarming improved mortality in children after brain injury. In this phase 3, multicenter, multinational, randomised controlled trial, we included patients with severe traumatic brain injury who were younger than 18 years and could be enrolled within 6 h of injury. We used a computer-generated randomisation sequence to randomly allocate patients (1:1; stratified by site and age [<6 years, 6–15 years, 16–17 years]) to either hypothermia (rapidly cooled to 32–33°C for 48–72 h, then rewarmed by 0·5–1·0°C every 12–24 h) or normothermia (maintained at 36·5–37·5°C). The primary outcome was mortality at 3 months, assessed by intention-to-treat analysis; secondary outcomes were global function at 3 months after injury using the Glasgow outcome scale (GOS) and the GOS-extended pediatrics, and the occurrence of serious adverse events. Investigators assessing outcomes were masked to treatment. This trial is registered with ClinicalTrials.gov, number NCT00222742. The study was terminated early for futility after an interim data analysis on data for 77 patients (enrolled between Nov 1, 2007, and Feb 28, 2011): 39 in the hypothermia group and 38 in the normothermia group. We detected no between-group difference in mortality 3 months after injury (6 [15%] of 39 patients in the hypothermia group vs two [5%] of 38 patients in the normothermia group; p=0·15). Poor outcomes did not differ between groups (in the hypothermia group, 16 [42%] patients had a poor outcome by GOS and 18 [47%] had a poor outcome by GOS-extended paediatrics; in the normothermia group, 16 [42%] patients had a poor outcome by GOS and 19 [51%] of 37 patients had a poor outcome by GOS-extended paediatrics). We recorded no between-group differences in the occurrence of adverse events or serious adverse events. Hypothermia for 48 h with slow rewarming does not reduce mortality of improve global functional outcome after paediatric severe traumatic brain injury. National Institute of Neurological Disorders and Stroke and National Institutes of Health.

Background Impaired oxygen delivery or blood flow to the brain around the time of birth can cause injury. Hypoxic ischaemic encephalopathy (HIE) is a leading cause of death and disability in term and near-term infants. Therapeutic hypothermia (TH) (reducing body temperature to 33–34 °C for 72 h after birth) is the only intervention available for infants with moderate-to-severe encephalopathy. TH should be initiated within 6 h of birth for maximum benefit. Many infants worldwide are not born in a centre where TH is possible, and transport is required for active TH. In Australia, the current method of active TH during transport involves ice-gel packs. There have been no prospective studies comparing active methods of TH in neonatal transport reporting short- and long-term outcomes. We aim to compare two active TH modalities: a battery servo-controlled cooling device and infant wrap (Criticool Mini and Cruewrap (Belmont Medical Technologies, MA, USA)) and standard care (ice-gel packs) for TH during the transport of newborns with HIE. Methods The CoolCot study will be conducted in the Newborn Emergency Transport Service of Western Australia (NETS WA), a single state-wide transport service. Eligible infants with confirmed or suspected HIE will be referred to NETS WA from healthcare facilities without tertiary health (TH) capacity in Western Australia. Following the arrival of the transport team, infants with informed consent will be randomly assigned to battery-enabled servo-controlled TH or standard care (ice-gel packs). The primary outcome will be the proportion of patients with a temperature in the range of 33.0–34.0 °C on arrival at the receiving unit. The secondary outcomes include the time to achieve the therapeutic temperature, the time spent out of the temperature range, the degree of temperature fluctuation and safety. Long-term measures: MRI brain findings (days 5–10 of life) and Bayley Scales of Infant Development assessment at 2 years. Discussion The CoolCot study is the first RCT to prospectively compare the effectiveness of active cooling methods in neonatal emergency transport. Reducing the time needed to achieve the target temperature is crucial in optimising neurodevelopmental outcomes. A key feature of this study is the neurodevelopmental assessment conducted at age two. Trial registration WHO ICTRP Registry/Australian New Zealand Clinical Trials Registry: ACTRN12623001298606p. The CoolCot trial was prospectively registered on 13th December 2023.

In this randomized trial involving newborn infants with asphyxial encephalopathy, hypothermic therapy did not significantly reduce the rate of the primary outcome (i.e., death or severe neurodevelopmental disability) but did result in improvement in several prespecified secondary neurologic outcomes among survivors. In newborn infants with asphyxial encephalopathy, hypothermic therapy did not significantly reduce the rate of the primary outcome (i.e., death or severe neurodevelopmental disability) but did result in improvement in several prespecified secondary neurologic outcomes among survivors. Perinatal asphyxial encephalopathy is associated with high morbidity and mortality rates worldwide and is a major burden for the patient, the family, and society. There is an urgent need to improve outcomes in affected infants. Experimentally, reducing body temperature to 3 to 5°C below the normal level reduces cerebral injury and improves neurologic function after asphyxia. 1 – 6 Preliminary clinical studies have found no serious adverse effects of cooling. 7 – 9 Two randomized, controlled trials, the CoolCap trial 10 and the National Institute of Child Health and Human Development (NICHD) trial, 11 have reported outcomes among infants at 18 months of age who had . . .

Acute ischemic stroke (AIS) remains a leading cause of disability and death globally, with limited effective neuroprotective strategies beyond reperfusion therapies. Despite advances in reperfusion treatments, many patients still experience poor outcomes, highlighting the urgent need for additional therapeutic approaches. We investigated whether intra-arterial local therapeutic hypothermia (IA-LTH) combined with endovascular treatment could improve outcomes in patients with AIS. We conducted a multicenter, randomized trial with blinded outcome assessment (ISOLATION trial), where outcome assessors and patients were blinded to treatment allocation while procedural staff could not be blinded, to test the effectiveness of IA-LTH for neuroprotection in AIS (registration number: ChiCTR2300074990). Between September 2023 and January 2024, we recruited 100 patients with anterior circulation large vessel occlusion within 24 h of stroke onset from 18 stroke centers in China. Participants were randomly assigned (1:1) to receive either IA-LTH plus standard care (including endovascular treatment and guideline-recommended medical therapy; intervention; n = 50) or standard care alone (control; n = 50). The IA-LTH group received intra-arterial infusion of 4 °C saline during and following endovascular treatment. Primary outcome was favorable functional outcome (modified Rankin Scale 0-2) at 90 days. Using intention-to-treat analysis, among participants (median age 69 years, 64% [64/100] male, median National Institutes of Health Stroke Scale score 14), the primary outcome did not reach statistical significance, with favorable outcome achieved in 58.0% (29/50) of the IA-LTH group versus 40.0% (20/50) of controls (adjusted relative risk [aRR] of 1.47 (95% CI [0.99, 2.16]; P = 0.055)). This lack of statistical significance is primarily due to the limited sample size of this pilot study, which was designed to assess feasibility and safety rather than provide definitive efficacy evidence. Safety outcomes, including rates of symptomatic intracranial hemorrhage (8.0% [4/50] versus 16.0% [8/50]) and mortality (20.0% [10/50] versus 22.0% [11/50]), were not significantly different between groups. The main limitations include the insufficient sample size of this pilot study which limited statistical power to detect differences in the primary outcome, the inability to adjust for potentially important confounders beyond age and ASPECTS due to the small sample size, and the higher incidence of pulmonary infections in the IA-LTH group that may have resulted from hypothermia-induced immune suppression or sedation-related factors. This pilot study provides preliminary insights suggesting that IA-LTH combined with endovascular therapy may be feasible and safe, with potential to improve functional outcomes in patients with AIS. The primary outcome did not reach statistical significance. However, the observed numerical differences suggest that IA-LTH warrants further investigation in larger trials. Chinese Clinical Trial Registry (ChiCTR) ChiCTR2300074990.

In this multicenter, randomized trial, the administration of erythropoietin to newborns undergoing therapeutic hypothermia for hypoxic–ischemic encephalopathy did not result in a lower risk of death or neurodevelopmental impairment at 22 to 36 months of age than placebo and was associated with a higher rate of serious adverse events.

PurposeCryotherapy is an increasingly popular recovery strategy used in an attempt to attenuate the negative impact of strenuous physical activity on subsequent exercise. Therefore, this study aimed to assess the effects of whole body cryotherapy (WBC) and cold water immersion (CWI) on markers of recovery following a marathon.MethodsThirty-one endurance trained males completed a marathon. Participants were randomly assigned to a CWI, WBC or placebo group. Perceptions of muscle soreness, training stress and markers of muscle function were recorded before the marathon and at 24 and 48 h post exercise. Blood samples were taken at baseline, post intervention and 24 and 48 h post intervention to assess inflammation and muscle damage.ResultsWBC had a harmful effect on muscle function compared to CWI post marathon. WBC positively influenced perceptions of training stress compared to CWI. With the exception of C-reactive protein (CRP) at 24 and 48 h, neither cryotherapy intervention positively influenced blood borne markers of inflammation or structural damage compared to placebo.ConclusionThe findings show WBC has a negative impact on muscle function, perceptions of soreness and a number of blood parameters compared to CWI, contradicting the suggestion that WBC may be a superior recovery strategy. Further, cryotherapy is no more effective than a placebo intervention at improving functional recovery or perceptions of training stress following a marathon. These findings lend further evidence to suggest that treatment belief and the placebo effect may be largely responsible for the beneficial effects of cryotherapy on recovery following a marathon.