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BACKGROUND: Animal models of serious infection suggest that 24 h of induced hypothermia improves circulatory and respiratory function and reduces mortality. We tested the hypothesis that a reduction of core temperature to 32-34°C attenuates organ dysfunction and reduces mortality in ventilator-dependent patients with septic shock.METHODS: In this randomised, controlled, open-label trial, we recruited patients from ten intensive care units (ICUs) in three countries in Europe and North America. Inclusion criteria for patients with severe sepsis or septic shock were a mean arterial pressure of less than 70 mm Hg, mechanical ventilation in an ICU, age at least 50 years, predicted length of stay in the ICU at least 24 h, and recruitment into the study within 6 h of fulfilling inclusion criteria. Exclusion criteria were uncontrolled bleeding, clinically important bleeding disorder, recent open surgery, pregnancy or breastfeeding, or involuntary psychiatric admission. We randomly allocated patients 1:1 (with variable block sizes ranging from four to eight; stratified by predictors of mortality, age, Acute Physiology and Chronic Health Evaluation II score, and study site) to routine thermal management or 24 h of induced hypothermia (target 32-34°C) followed by 48 h of normothermia (36-38°C). The primary endpoint was 30 day all-cause mortality in the modified intention-to-treat population (all randomly allocated patients except those for whom consent was withdrawn or who were discovered to meet an exclusion criterion after randomisation but before receiving the trial intervention). Patients and health-care professionals giving the intervention were not masked to treatment allocation, but assessors of the primary outcome were. This trial is registered with ClinicalTrials.gov, number NCT01455116.FINDINGS: Between Nov 1, 2011, and Nov 4, 2016, we screened 5695 patients. After recruitment of 436 of the planned 560 participants, the trial was terminated for futility (220 [50%] randomly allocated to hypothermia and 216 [50%] to routine thermal management). In the hypothermia group, 96 (44·2%) of 217 died within 30 days versus 77 (35·8%) of 215 in the routine thermal management group (difference 8·4% [95% CI -0·8 to 17·6]; relative risk 1·2 [1·0-1·6]; p=0·07]).INTERPRETATION: Among patients with septic shock and ventilator-dependent respiratory failure, induced hypothermia does not reduce mortality. Induced hypothermia should not be used in patients with septic shock.FUNDING: Trygfonden, Lundbeckfonden, and the Danish National Research Foundation.

Background and objective The aim of this study was to determine the agreement between pulmonary artery thermodilution (PA-TD) and a new pulse contour method (PCM), FloTrac/Vigileo version 1.0, and to asses the ability of FloTrac to track sudden changes in cardiac output. Methods Cardiac output was determined twice after induction of anaesthesia, but before cardiac surgery, with both PA-TD and a PCM in order to determine the precision of both methods. The bias and agreement between the two methods were calculated using Bland-Altman analysis. Postoperatively, in patients with heart rates under 60 beats min(-1), atrial pacing was initiated and cardiac output was determined before and after with both methods. Results Twenty-five patients were investigated. The precisions of PA-TD and the PCM were 0.35 (95% confidence interval +/-0.12) and 0.6 l min(-1) (95% confidence interval +/-0.21%). The bias between PA-TD and the PCM was -0.51 l min(-1) and the limits of agreement were +/-1.87 l min(-1) (95% confidence interval +/-0.39 and +/-0.66). The percentage error was 48%. The changes in cardiac output with atrial pacing were in the same direction in all nine patients. Conclusion In this study, agreement between PA-TD and the PCM was poor, but the PCM was able to track the direction of pace-induced changes in cardiac output.