Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis

• Status: Recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Treatments: Vasoconstrictor Agents

Criteria

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)

• Unable to obtain informed consent

• Known pregnancy

• Hypotension suspected to be due to non-sepsis cause (e.g. hemorrhagic shock)

• Blood pressure is at known or reported baseline level

• Severe Volume Depletion from an acute condition other than sepsis. In the judgment of the treating physician, the patient has an acute condition other than sepsis causing (or indicative) of *severe volume depletion; Examples include: Diabetic ketoacidosis, high volume vomiting or diarrhea, hyperosmolar hyperglycemic state, and nonexertional hyperthermia (heat stroke); severe is defined by the need for substantial intravenous fluid administration as part of routine clinical care

• Pulmonary edema or clinical signs of new fluid overload (e.g. bilateral crackles, new oxygen requirement, new peripheral edema, fluid overload on chest x-ray)

• Treating physician unwilling to give additional fluids as directed by the liberal protocol

• Treating physician unwilling to use vasopressors as directed by the restrictive protocol.

• Current or imminent decision to withhold most/all life-sustaining treatment; this does not exclude those patients committed to full support except cardiopulmonary resuscitation

• Immediate surgical intervention planned such that study procedures could not be followed

• Prior enrollment in this study