Resuscitation With Plasma in Surgical and Trauma Patients With Septic Shock



Status:Enrolling by invitation
Conditions:Hospital, Hospital
Therapuetic Areas:Other
Healthy:No
Age Range:18 - Any
Updated:4/17/2018
Start Date:March 26, 2018
End Date:April 26, 2019

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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.


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 renal replacement therapy or 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
We found this trial at
1
site
7000 Fannin St
Houston, Texas 77030
(713) 500-4472
Phone: 706-372-6455
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
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mi
from
Houston, TX
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