Primary PETAL Studies
Reevaluation of Systemic Early Neuromuscular Blockade (ROSE)
This study was evaluating whether giving a neuromuscular blocker (skeletal muscle relaxant) to a patient with acute respiratory distress syndrome will improve survival. Half of the patients received a neuromuscular blocker for two days and in the other half the use of neuromuscular blockers will be discouraged.
Low Tidal Volume Universal Support: Feasibility of Recruitment for Interventional Trial (LOTUS FRUIT)
This was an observational study that collected data from sites to assess hospital mechanical ventilation practices. The purpose of this study was to (1) inform the design and plan for future interventional trials of low tidal volume ventilation in emergency departments and intensive care units and (2) determine the practicality of data collection for patients with acute respiratory failure in trials. Data was collected for a one-month period at all PETAL hospitals to determine the feasibility of performing a larger randomized controlled trial.
Vitamin D to Improve Outcomes by Leveraging Early Treatment (VIOLET)
This study looked at the effect of early administration of high-dose vitamin D₃ in reducing mortality in patients with low levels of Vitamin D who are at high risk for acute respiratory distress syndrome (ARDS). Patients were screened for vitamin D deficiency (levels less than 20ng/mL). Those patients meeting the screening threshold were be randomized into the trial. Half of the vitamin D deficient patients were given a high dose of vitamin D₃, and the other half were given a placebo (like a sugar pill).
Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis (CLOVERS)
The CLOVERS study compared two methods of increasing blood pressure in patients with dangerously low blood pressure due to a suspected infection. One method is to first provide intravenous fluids to the patient, and then use medicines to raise blood pressure; the other method is to use the blood pressure medicines first, and then use fluids.
Acetaminophen in Sepsis: Target Therapy to Enhance Recovery (ASTER)
Many patients hospitalized with sepsis develop organ failure, including acute lung injury (ARDS), kidney injury, and cardiovascular dysfunction. This study aimed to test whether acetaminophen (also known as Tylenol) can improve survival for patients with sepsis.
The ASTER trial originally studied both acetaminophen and Vitamin C. The Vitamin C arm of the trial was stopped on June 15th and a revised study protocol studying a higher dose of acetaminophen versus placebo was proposed by PETAL investigators and approved by NHLBI and the Institutional Review Board overseeing PETAL studies. Enrollment began in the revised trial on August 16, 2022.