Status:
TERMINATED
Resuscitation With Plasma in Surgical and Trauma Patients With Septic Shock
Lead Sponsor:
The University of Texas Health Science Center, Houston
Conditions:
Septic Shock
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 wit...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 26 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 16 2019
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT03366220
Start Date
March 26 2018
End Date
October 16 2019
Last Update
April 13 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030