Sepsis induced hypotension: US consumer group asks regulator to stop trial, arguing flawed design

The US consumer advocacy group Public Citizen has written to the Office for Human Research Protections, which oversees ethical and regulatory issues in biomedical research, asking it to immediately direct the National, Heart, Lung and Blood Institute (NHLBI) to stop enrolment of patients into a clinical trial of sepsis induced hypotension that it is funding and to launch an investigation into how the study was approved.1

The Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis (CLOVERS) trial is a phase III randomised, non-blinded trial of fluid treatment strategies in the first 24 hours for patients with sepsis induced hypotension.2 The trial plans to assign 2320 adult patients to a restrictive fluids strategy (vasopressors first, followed by rescue fluids) or a liberal fluid strategy (fluids …