Table 1 Trials included in the clinician surveya
From: Effect sizes in ongoing randomized controlled critical care trials
Trial name | Participants | Intervention | Comparator | Outcome | Baseline mortality (%) | Postulated mortality effectb (%) | Power (%) | Sample Size |
|---|---|---|---|---|---|---|---|---|
A Confirmatory Phase II/III Study Assessing Efficacy, Immunogenicity and Safety of IC43 Recombinant Pseudomonas Vaccine in Intensive Care Patients | Adults requiring ICU ventilation for ≥48 h | Recombinant Pseudomonas vaccine | Placebo | Day 28 mortality | 27.5 | 10 | 90 | 800 |
ADjunctive coRticosteroid trEatment iN criticAlly ilL Patients with Septic Shock | Adults who are ventilated with septic shock | Hydrocortisone | Placebo | Day 90 mortality | 33 | 5 | 90 | 3800 |
Early Spontaneous Breathing in ARDS | Adults ventilated with ARDS | APRV | Volume control ventilation | Day 28 mortality | 35 | 10 | 80 | 700 |
Non-sedation versus Sedation with a Daily Wake-up Trial in Critically Ill Patients Receiving Mechanical Ventilation | Adults ventilated in ICU | Nonsedation | Daily awakening | Day 90 mortality | 39 | 10 | 80 | 700 |
Stress Ulcer Prophylaxis in the Intensive Care Unit | Adults with shock, coagulopathy, or receiving RRT or ventilation | Pantoprazole | Placebo | Day 90 mortality | 25 | 5 | 90 | 3350 |
The Augmented versus Routine Approach to Giving Energy Trial | Ventilated adults expected to require enteral nutrition for ≥2 days in ICU | Nutrition at 1.5 kcal/kg/h | Nutrition at 1.0 kcal/kg/h | Day 90 mortality | 25 | 3.95 | 80 | 4000 |
The SuDDICU Cluster RCT of Antibiotic Prophylaxis in Critical Illness | Adults ventilated for ≥24 h in the ICU | SDD | Placebo | In-hospital mortality | 25 | 3.5 | 90 | 24,000 |
Ticagrelor in Severe CAP | Adults with severe CAP requiring ICU admission | Ticagrelor | Placebo | Day 90 mortality | 33 | 11 | 80 | 568 |
Tranexamic acid for the treatment of gastrointestinal haemorrhage: an international randomised, double-blind placebo-controlled trial | Adults with acute significant GI bleeding | Tranexamic acid | Placebo | Day 28 mortality | 10 | 2.5 | 90 | 8000 |
Tranexamic acid for the treatment of significant traumatic brain injury: an international, randomised, double-blind, placebo-controlled trial | Traumatic brain injury | Tranexamic acid | Placebo | Day 28 mortality | 20 | 3 | 90 | 10,000 |