Matt Harmon

180 Chapter nine TTM protocol Within the TTM-trial patients were randomized to a temperature of 33°C (TTM33) or 36°C (TTM36). 28 hours after randomization patients were gradually rewarmed to 37°C at a maximum speed of 0.5°C per hour. The total intervention period was 36 hours. Antibiotics were administered according to local protocols at each site. Final treatment decisions regarding antibiotics were taken by the treating physician. Infectious complications Data on infectious complications and clinical parameters were gathered by the treating physician, using an electronic case report form (eCRF) . Daily scoring of suspected pneumonia was based on a new pulmonary or progressive infiltrate on chest X-ray and the presence of one or more of the following clinical features: fever (>38,0°C), leukocytosis (>12.000 cells/L) and purulent tracheobronchial secretions. 13,14 Due to temperature management, no minimum number of criteria was specified for the diagnosis of pneumonia. Pneumonia was considered confirmed if the local laboratory identified a causative organism in the pulmonary secretion samples in combination with above mentioned clinical symptoms. Bacteremia was defined as a positive blood culture with a pathogenic organism. Blood cultures that were positive with commensal skin flora were considered contaminated unless two separate, consecutive blood cultures were positive with the same microorganism. In this post-hoc study, participating centers of the TTM-trial were asked to complete an eCRF with data on microbiological culture results and antibiotic use in the first 14 days of admission. This included queries on microorganisms in pulmonary secretion samples, blood cultures and urine cultures and use of prophylactic antibiotics, including selective digestive tract decontamination (SDD), which comprises of oral and gastric delivery of non-absorbable antibiotics for the duration of IC stay as well as a cephalosporin for the duration of four days. Statistical analysis Statistical significance in baseline characteristics between groups was evaluated by the Student’s T-test for normally distributed continuous variables and the Mann-Whitney test for non-normally distributed continuous variables. The Chi- square test was used for comparing categorical variables. Categorical variables were expressed in absolute numbers and percentages.