Primary studies included in this systematic review

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期刊 Journal of tropical pediatrics
Year 2013
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OBJECTIVES: To evaluate in term babies with perinatal asphyxia, the effect of therapeutic hypothermia (TH) on oxidative stress and neurological outcome at discharge. METHODS: Babies who satisfied inclusion criteria were randomized to TH, with cooling gel packs to a target temperature of 33-34°C for 72 h or normothermia. Blood sample was collected before and after TH for oxidative stress assessment: total antioxidant status (TAS) and malondialdehyde (MDA). RESULTS: Of 116 babies randomized, there was no statistically significant difference in the baseline TAS and MDA. After 72 h of TH, TAS was significantly higher (p = <0.001) (761.69 ± 114.01 vs. 684.16 ± 88.86) and MDA was significantly lower (p = <0.001) in TH group (1.73 ± 0.66 vs. 5.2 ± 1.06). Risk of developing deficit was lower (p < 0.001) in TH group with relative risk of 0.49 and 95 % confidence interval: 0.29-0.68. CONCLUSION: TH reduces oxidative stress and improves neurological outcome in perinatal asphyxia. TRIAL REGISTRATION NUMBER: CTRI/2011/12/002196.

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作者 Bharadwaj SK , Bhat BV
期刊 Journal of tropical pediatrics
Year 2012
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目的:探讨低温治疗(TH),使用凝胶包在降低死亡率和发病率在足月新生儿缺氧缺血性脑病的疗效,研究与TH的相关问题。 方法:缺氧缺血性脑病婴儿被随机分为TH和对照组。在TH组婴儿被冷却出生用布盖冷却凝胶包,以保持33-34℃。目标肛温前72h婴儿随访至6个月,使用巴罗达发育筛查测验进行了评估。 结果:有在基线参数无显著差异。TH组有显著降低死亡或发育迟缓的结合率在6个月以下的21%(在TH组8.1%比对照29%,RR 0.28,95%CI:0.11-0.70,P = 0.003)。 结论:TH用凝胶包减少死亡或发育迟缓在6个月以下的婴儿缺氧缺血性脑病的风险。

Primary study

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期刊 The American journal of cardiology
Year 2011
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Radiocontrast nephropathy (RCN) develops in a substantial proportion of patients with chronic kidney disease (CKD) after invasive cardiology procedures and is strongly associated with subsequent mortality and adverse outcomes. We sought to determine whether systemic hypothermia is effective in preventing RCN in patients with CKD. Patients at risk for RCN (baseline estimated creatinine clearance 20 to 50 ml/min) undergoing cardiac catheterization with iodinated contrast ≥50 ml were randomized 1:1 to hydration (control arm) versus hydration plus establishment of systemic hypothermia (33°C to 34°C) before first contrast injection and for 3 hours after the procedure. Serum creatinine levels at baseline, 24 hours, 48 hours, and 72 to 96 hours were measured at a central core laboratory. The primary efficacy end point was development of RCN, defined as an increase in serum creatinine by ≥25% from baseline. The primary safety end point was 30-day composite rate of adverse events consisting of death, myocardial infarction, dialysis, ventricular fibrillation, venous complication requiring surgery, major bleeding requiring transfusion ≥2 U, or rehospitalization. In total 128 evaluable patients (mean creatinine clearance 36.6 ml/min) were prospectively randomized at 25 medical centers. RCN developed in 18.6% of normothermic patients and in 22.4% of hypothermic patients (odds ratio 1.27, 95% confidence interval 0.53 to 3.00, p = 0.59). The primary 30-day safety end point occurred in 37.1% versus 37.9% of normothermic and hypothermic patients, respectively (odds ratio 0.97, 95% confidence interval 0.47 to 1.98, p = 0.93). In conclusion, in patients with CKD undergoing invasive cardiology procedures, systemic hypothermia is safe but is unlikely to prevent RCN.

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Primary study

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期刊 Circulation. Cardiovascular interventions
Year 2010
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Background-Experimental studies have shown that induction of hypothermia before reperfusion of acute coronary occlusion reduces infarct size. Previous clinical studies, however, have not been able to show this effect, which is believed to be mainly because therapeutic temperature was not reached before reperfusion in the majority of the patients. We aimed to evaluate the safety and feasibility of rapidly induced hypothermia by infusion of cold saline and endovascular cooling catheter before reperfusion in patients with acute myocardial infarction. Methods and Results-Twenty patients with acute myocardial infarction scheduled to undergo primary percutaneous coronary intervention were enrolled in this prospective, randomized study. After 4±2 days, myocardium at risk and infarct size were assessed by cardiac magnetic resonance using T2-weighted imaging and late gadolinium enhancement imaging, respectively. A core body temperature of <35°C (34.7±0.3°C) was achieved before reperfusion without significant delay in door-to-balloon time (43±7 minutes versus 40±6 minutes, hypothermia versus control, P=0.12). Despite similar duration of ischemia (174±51 minutes versus 174±62 minutes, hypothermia versus control, P=1.00), infarct size normalized to myocardium at risk was reduced by 38% in the hypothermia group compared with the control group (29.8±12.6% versus 48.0±21.6%, P=0.041). This was supported by a significant decrease in both peak and cumulative release of Troponin T in the hypothermia group (P=0.01 and P=0.03, respectively). Conclusions-The protocol demonstrates the ability to reach a core body temperature of <35°C before reperfusion in all patients without delaying primary percutaneous coronary intervention and that combination hypothermia as an adjunct therapy in acute myocardial infarction may reduce infarct size at 3 days as measured by MRI. © 2010 American Heart Association, Inc. © 2010 American Heart Association, Inc.

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Primary study

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期刊 Hospital practice (1995)
Year 2009
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OBJECTIVE: To evaluate the efficacy of systemic hypothermia when applied within 10 hours after birth to neonates with hypoxic-ischemic encephalopathy (HIE). STUDY DESIGN: Ninety-three term infants with moderate-to-severe HIE were randomly assigned to either systemic hypothermia (n = 46) or conventional treatment (n = 47). Hypothermia was induced within 10 hours after birth, decreasing rectal temperature to 33.5°C for 72 hours, followed by slow rewarming to 36.5°C. Neurodevelopmental outcome was assessed at 18 months old. The primary outcome was death or moderate-to-severe disability. RESULTS: Outcome data were available for 82 infants. Death or moderate-to-severe disability occurred in 21 of 44 infants (47.7%) in the control group and in 7 of 38 infants (18.4%) in the hypothermia group (P = 0.01) at 18 months. The primary outcome was not different whether hypothermia was started within 6 hours or 6 to 10 hours after birth. Subgroup analysis suggested that systemic hypothermia improved long-term outcome only in infants with moderate HIE (P = 0.009), but not in those with severe HIE. No severe hypothermia-related adverse events were observed. CONCLUSION: Systemic hypothermia reduced the risk of disability in infants with moderate HIE, in accordance with earlier studies. Hypothermia was induced within 6 hours in most infants, but delaying the onset to 6 to 10 hours after birth did not negatively affect primary outcome. Further studies with a large number of patients are needed to confirm that delayed cooling is equally effective.

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背景:亚低温治疗提高生存和神经系统的结果,在创伤性脑损伤的动物模型。然而,亚低温治疗重型颅脑损伤儿童神经系统的结果和死亡率的影响是未知的。 方法:在一项多中心,国际审判,我们随机分配儿童重型颅脑损伤,无论是低温疗法(32.5度ç24小时),8小时后,受伤或常温(37.0摄氏度)内发起。主要成果是有不利的结果(即严重残疾,植物人或死亡),小儿脑性能类别得分在6个月的基础上评估儿童的比例。 结果:共有225名儿童被随机分配到低温组或常温组;两组中所取得的平均气温分别为33.1 + / -1.2度C和36.9 + / -0.5摄氏度,分别。在6个月,31%的患者在低温组,有22%的患者在常温组相比,有一个不利的结果(相对风险,1.41; 95%的信心区间[CI],0.89至2.22,P = 0.14)。有23人死亡(21%)在低温组和14人死亡,在常温组(12%)(相对风险,1.40; 95%CI,0.90至2.27,P = 0.06)。有更多的低血压(p = 0.047)和低温组(P <0.01),比在常温组在复温期间的管理更多的血管活性药物。逗留在重症监护病房,并在医院和其他不良事件的长度在两组相似。 结论:在儿童重型颅脑损伤,亚低温治疗,伤后8小时内开始,并持续24小时不改善神经系统的结果,并可能增加死亡率。(电流控制试验次数,ISRCTN77393684 [控制trials.com]。)。

Primary study

Unclassified

作者 Qiu W , Zhang Y , Sheng H , Zhang J , Wang W , Liu W , Chen K , Zhou J , Xu Z
期刊 Journal of critical care
Year 2007
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目的:探讨严重创伤性脑损伤(TBI)的开颅手术后的患者亚低温治疗的效果。 方法:单侧开颅手术后80例重度脑外伤患者,随机分为4天保持在33摄氏度至35摄氏度的低温治疗与脑温组,常温对照组在重症监护病房。生命体征,颅内压增高,血清超氧化物歧化酶水平,格拉斯哥预后评分,并发症进行前瞻性分析。 结果:在24的低温治疗组,48,伤后72小时内的平均颅内压值分别比对照组低(23.49 + / - 2.38,24.68 + / - 1.71,22.51 + / - 2.44 + / - 2.18,25.90和25.87 + / - 1.86,和24.57 + / - 3.95毫米汞柱,P = .000,.000,.003,分别)。3和7天的低温治疗组平均血清超氧化物歧化酶水平比对照组高出许多,在同一时间点(533.0 + / - 103.4和600.5 + / - 82.9比458.7 + / - 68.1和497.0 + / - 57.3马克杯/ L,分别为,P = .000)。有利神经系统的结果1伤后一年的百分比是70.0%和47.5%,分别为(p = 0.041)。并发症,包括肺部感染(57.5%,在低温治疗组与对照组的32.5%,P = 0.025),管理无严重后遗症。 结论:亚低温治疗严重脑外伤开颅手术后的病人在重症监护病房提供一个有前途的方法。