Resuscitation With Plasma in Surgical and Trauma Patients With Septic Shock

• Status: Enrolling by invitation
• Trial end date: 2021-04-26
• Target enrollment: 0
• Participant gender: All

Summary

There is a knowledge gap regarding the optimal initial fluid to achieve effective resuscitation and improved outcomes in septic shock. The purpose of this study is to compare initial resuscitation with plasma to initial resuscitation with balanced crystalloids.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Texas Health Science Center, Houston

Criteria

Inclusion Criteria:

• Patients meeting the following criteria will be enrolled: Have a Sepsis Screening Score (SSS) ≥ 4 with a suspected source of infection (Table 1); and Written informed consent obtained

• Patients meeting any of the following criteria will be randomized: Hypotension with MAP < 65 mmHg; Lactic acid > 4 mmol/L; Altered mental status; and Decreased urine output of < 0.5 mL/kg in the past hour.

Exclusion Criteria:

• Pregnancy

• Prisoners

• Traumatic brain injury

• Evidence of ongoing hemorrhage, history of congenital bleeding disorders, therapeutic anticoagulation

• History of myocardial infarction or congestive heart failure

• History of acute cerebral vascular event

• Major burns (>20% total body surface area)

• History of adverse reactions to blood product transfusion

• Contraindications to blood transfusions (eg. Jehovah's Witness)

• Contraindications to central venous line and arterial line placement

• On intermittent hemodialysis

• Do-Not-Resuscitate or Comfort Care status

• Participation in another interventional study

• Pending transfer to another unit within the hospital that is not STICU or SIMU