Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis (CLOVERS)

Multicenter, prospective, phase 3 randomized non-blinded interventional trial of fluid treatment strategies in the first 24 hours for patients with sepsis-induced hypotension. The aim of the study is to determine the impact of a restrictive fluids strategy (vasopressors first followed by rescue fluids) as compared to a liberal fluid strategy (fluids first followed by rescue vasopressors) on 90-day in-hospital mortality in patients with sepsis-induced hypotension.

I'M INTERESTED

This research study is led by Dr. Jay Steingrub.

Contact: Sherell Thornton-Thompson, 413-794-9056

Participation details:

1181039
Pulmonary/ Critical Care
Baystate Medical Center, 759 Chestnut St, Springfield, MA

Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Inclusion Criteria:

  • Age ≥ 18 years
  • A suspected or confirmed infection (broadly defined by administration or planned administration of antibiotics)
  • Sepsis-induced hypotension defined as systolic blood pressure < 100 mmHg or MAP < 65 mmHg after a minimum of at least 1 liter of fluid (*Fluids inclusive of pre-hospital fluids; blood pressure must be below any known or reported pre-morbid baseline).

Exclusion Criteria:

  • More than 4 hours elapsed since meeting inclusion criteria or 24 hours elapsed since admission to the hospital
  • Patient already received 3 liters of intravenous fluid (includes prehospital volumes)
  • Known pregnancy
  • Blood pressure is at known or reported baseline level
Recruiting
Interventional (Clinical Trial), Randomized
3