Crit Care Resusc
-
Randomized Controlled Trial Multicenter Study Comparative Study
Statistical analysis plan for the Crystalloid Versus Hydroxyethyl Starch Trial (CHEST).
The Crystalloid Versus Hydroxyethyl Starch Trial (CHEST) is a 7000-patient, multicentre, randomised controlled trial comparing the effects of 6% hydroxyethyl starch (130/0.4) to normal saline for fluid resuscitation in intensive care patients. The trial design is based on the Saline Versus Albumin Fluid Evaluation (SAFE) study and will be the largest fluid resuscitation trial conducted to date. ⋯ We have developed a predetermined SAP for CHEST. This plan accords with high-quality standards of internal validity to minimise analysis bias.
-
Randomized Controlled Trial
Increased brain tissue oxygen tension in children with traumatic brain injury using temperature-corrected guided ventilation during prophylactic hypothermia.
To investigate whether ventilatory management using a temperature-corrected (pH-stat) or uncorrected (alpha-stat) blood gas analysis strategy improves brain tissue oxygen tension (PbrO(2)) in children prophylactically treated with moderate hypothermia for traumatic brain injury. ⋯ PbrO(2) may be improved using a pH-stat blood gas management strategy in prophylactic hypothermia for paediatric patients with traumatic brain injury without any clinically relevant increase in ICP.