Impact of Fever Prevention in Brain-Injured Patients (INTREPID): Study Protocol for a Randomized Controlled Trial.

BACKGROUND: Multiple studies demonstrate that fever/elevated temperature is associated with poor outcomes in patients with vascular brain injury; however, there are no conclusive studies that demonstrate that fever prevention/controlled normothermia is associated with better outcomes. The primary objective of the INTREPID (Impact of Fever Prevention in Brain-Injured Patients) trial is to test the hypothesis that fever prevention is superior to standard temperature management in patients with acute vascular brain injury. METHODS: INTREPID is a prospective randomized open blinded endpoint study of fever prevention versus usual care in patients with ischemic or hemorrhagic stroke. The fever prevention intervention utilizes the Arctic Sun System and will be compared to standard care patients in whom fever may spontaneously develop. Ischemic stroke, intracerebral hemorrhage or subarachnoid hemorrhage patients will be included within disease-specific time-windows. Both awake and sedated patients will be included, and treatment is initiated immediately upon enrollment. Eligible patients are expected to require intensive care for at least 72 h post-injury, will not be deemed unlikely to survive without severe disability, and will be treated for up to 14 days, or until deemed ready for discharge from the ICU, whichever comes first. Fifty sites in the USA and worldwide will participate, with a target enrollment of 1176 patients (1000 evaluable). The target temperature is 37.0 °C. The primary efficacy outcome is the total fever burden by °C-h, defined as the area under the temperature curve above 37.9 °C. The primary secondary outcome, on which the sample size is based, is the modified Rankin Scale Score at 3 months. All efficacy analyses including the primary and key secondary endpoints will be primarily based on an intention-to-treat population. Analysis of the as-treated and per protocol populations will also be performed on the primary and key secondary endpoints as sensitivity analyses. DISCUSSION: The INTREPID trial will provide the first results of the impact of a pivotal fever prevention intervention in patients with acute stroke ( www.clinicaltrials.gov ; NCT02996266; registered prospectively 05DEC2016).

Multicenter cohort study to assess the impact of a silver-alloy and hydrogel-coated urinary catheter on symptomatic catheter-associated urinary tract infections.

PURPOSE: The purpose of this study was to determine the effect of a silver-alloy hydrogel catheter on symptomatic catheter-associated urinary tract infections (CAUTIs). DESIGN: Multicenter before-after non-randomized cohort study. SUBJECTS AND SETTING: Seven acute care hospitals ranging in size from 124 to 607 beds participated in this study. The study population included adult patients with a positive urine culture 2 or more days after admission, who underwent Foley catheterization. METHODS: Catheter-associated urinary tract infection surveillance was conducted at each hospital for at least 3 months during the use of a standard catheter and 3 months during the use of the silver-alloy hydrogel catheter. Both the National Healthcare Safety Network (NHSN) surveillance and a clinical definition of CAUTI were used for rate calculation. RESULTS: A 47% relative reduction in the CAUTI rate was observed with the silver-alloy hydrogel catheter compared to the standard catheter when both infection definitions were used (0.945/1000 patient days vs 0.498/1000 patient days) (odds ratio = 0.53; P < .0001; 95% CI: 0.45-0.62). When only NHSN-defined CAUTIs were considered, a 58% relative reduction occurred in the silver-alloy hydrogel period (0.60/1000 patient days vs 0.25/1000 patient days) (odds ratio = 0.42; P < .0001; 95% CI: 0.34-0.53). Antimicrobial days for CAUTIs decreased from 1165 (standard catheter period) to 406 (silver-alloy hydrogel period). CONCLUSIONS: Use of a silver-alloy hydrogel urinary catheter reduced symptomatic CAUTI occurrences as defined by both NHSN and clinical criteria.

Retention cuff pressure study of 3 indwelling stool management systems: randomized study of 10 healthy subjects.

PURPOSE: The purpose of this study was to compare retention cuff pressures of 3 indwelling stool management systems while subjects assumed different body positions and while cuffs were inflated to different volumes. METHODS: Retention cuff pressure study of 3 indwelling stool management systems was a randomized, crossover, open-label pilot study of 10 healthy adult volunteers in 3 body positions (supine, right side, and left side), 3 head-of-bed elevations (20°, 30°, and 40°), and 3 cuff overfill volumes (5, 10, and 15 mL). The devices were DigniCare Stool Management System (device A; Bard Medical Division, C. R. Bard, Inc, Covington, Georgia), Flexi-Seal Fecal Management System (device B; ConvaTec, a division of E. R. Squibb & Sons, LLC, Princeton, New Jersey), and ActiFlo Indwelling Bowel Catheter System (device C; Hollister, Inc, Libertyville, Illinois). We assessed cuff pressure by manometry and rectal mucosa by digital examination and small-diameter, flexible endoscopy. RESULTS: Cuffs were appropriately seated in the rectal vault for all 3 devices in all body positions and overfill volumes. Rectal mucosal abnormalities were observed in 4 of 10 subjects (40%) after removal of device A, 1 of 5 (20%) after removal of device B, and 3 of 5 (60%) after removal of device C. Retention cuff pressure was at least 2-fold lower for device A than for device B or C in all body positions, head-of-bed elevations, and device overfill volumes. For example, mean pressure while subjects were on their left sides was 25.0 mm Hg for device A, 79.2 mm Hg for device B, and 67.2 mm Hg for device C. Corresponding pressures at 15 mL of overfill were 52.5, 102.0, and 94.0 mm Hg. Subject comfort scores were comparable for all 3 devices. CONCLUSION: All devices appeared to seat well within the rectal vault, but device A was associated with cuff pressure measurements that were consistently lower than those of devices B and C. More studies are needed to elucidate the clinical relevance of these findings and whether they translate to differences in patient safety or comfort.