Clinical trial NCT03366220: Resuscitation With Plasma in Surgical and Trauma Patients With Septic Shock
Official title: Resuscitation With Plasma in Surgical and Trauma Patients With Septic Shock
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Septic Shock
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2017-12-08
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 with plasma to initial resuscitation with balanced crystalloids.


Eligibility 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

Primary outcomes:
measure: Glycocalyx Breakdown as Assessed by Syndecan-1 Levels
timeFrame: 0, 2, end of initial bolus of fluid administration (about 3 hours), 12, and at 24 hours
measure: Glycocalyx Breakdown and Endothelial Leakage as Assessed by Soluble Thrombomodulin (sTM)
timeFrame: 0, 2, end of initial bolus of fluid administration (about 3 hours), 12, and 24 hours
measure: Endothelial Leakage as Assessed by Soluble FMS-like Tyrosine Kinase-1 (sFLT-1)
timeFrame: 0, 2, end of initial bolus of fluid administration(about 3 hours), 12, and 24 hours
measure: Endothelial Leakage and Inflammation as Assessed by Vascular Endothelial Growth Factor (VEGF)
timeFrame: 0, 2, end of initial bolus of fluid administration (about 3 hours), 12, and 24 hours
measure: Sympatho-adrenal Activation as Assessed by Norepinephrine (NE)
timeFrame: 0, 2, end of initial bolus of fluid administration (about 3 hours), 12, and 24 hours
measure: Sympatho-adrenal Activation as Assessed by Epinephrine (Epi)
timeFrame: 0, 2, end of initial bolus of fluid administration (about 3 hours), 12, and 24 hours
measure: Inflammation as Assessed by Soluble Receptor for Advanced Glycation Endproduct (sRAGE)
timeFrame: 0, 2, end of initial bolus of fluid administration, 12, and 24 hours
measure: Inflammation as Assessed by High Mobility Group Protein-1 (HMGB-1)
timeFrame: 0, 2, end of initial bolus of fluid administration, 12, and 24 hours
measure: Inflammation as Assessed by Interleukin-6 (IL-6)
timeFrame: 0, 2, end of initial bolus of fluid administration (about 3 hours), 12, and 24 hours
measure: Inflammation as Assessed by Interleukin-8 (IL-8)
timeFrame: 0, 2, end of initial bolus of fluid administration (about 3 hours) , 12, and 24 hours
measure: Inflammation as Assessed by Interleukin-10 (IL-10)
timeFrame: 0, 2, end of initial bolus of fluid administration (about 3 hours), 12, and 24 hours
measure: Inflammation as Assessed by Interleukin-1α (IL-1α)
timeFrame: 0, 2, end of initial bolus of fluid administration (about 3 hours), 12, and 24 hours
measure: Inflammation as Assessed by Interleukin-1β (IL-1β)
timeFrame: 0, 2, end of initial bolus of fluid administration (about 3 hours), 12, and 24 hours
Secondary outcomes:
measure: Total Volume of Fluid Required for Resuscitation After the Initial Bolus of Either Plasma or Crystalloids
timeFrame: First 24 hours after initiation of fluid resuscitation
measure: Time Until Lactate Normalization
timeFrame: First 24 hours after initiation of fluid resuscitation
measure: Time on Vasopressors
timeFrame: First 30 days after initiation of fluid resuscitation
measure: Number of Days on Ventilator Support
timeFrame: First 30 days after initiation of fluid resuscitation
measure: Number of Intensive Care Unit (ICU)-Free Days
timeFrame: First 30 days after initiation of fluid resuscitation
measure: Number of Hospital Days
timeFrame: From the time of initiation of fluid resuscitation to the time of hospital discharge (up to about 170 days)
measure: Mortality
timeFrame: First 30 days after initiation of fluid resuscitation
measure: Number of Participants With Acute Lung Injury
timeFrame: First 30 days after initiation of fluid resuscitation
measure: Number of Participants With Acute Kidney Injury
timeFrame: First 30 days after initiation of fluid resuscitation
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Shuyan Wei, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wei S, Kao LS, Wang HE, Chang R, Podbielski J, Holcomb JB, Wade CE. Protocol for a pilot randomized controlled trial comparing plasma with balanced crystalloid resuscitation in surgical and trauma patients with septic shock. Trauma Surg Acute Care Open. 2018 Sep 23;3(1):e000220. doi: 10.1136/tsaco-2018-000220. eCollection 2018.