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.
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.
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.
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.