Resuscitation With Plasma in Surgical and Trauma Patients With Septic Shock

The University of Texas System (UT)

Status and phase: Terminated; Phase 2

Conditions: Septic Shock

Treatments: Drug: Plasma; Drug: Balanced crystalloids

Study type: Interventional

Funder types: Other

Identifiers

NCT03366220

HSC-MS-17-0714

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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16 participants in 2 patient groups

initial resuscitation with plasma

Experimental group

Description:

Initial resuscitation with plasma will be 10 mL/kg (700 mL in a typical 70 kg adult). Traditional doses of plasma, when used to correct coagulopathy range from 10-15 mL/kg.23 The plasma will be administered at a rate of 2-3 mL/kg/hr (140-210 mL/hr in a typical 70 kg adult). A research physician will be at bedside to follow patient resuscitation. Plasma administration may be terminated before the entire dose is administered if patients show clinical improvement. After the initial dose of plasma has been given, subsequent resuscitation will follow usual care using balanced crystalloids.

Treatment:

Drug: Plasma

initial resuscitation with balanced crystalloids

Active Comparator group

Description:

Usual care using balanced crystalloids (Iso-Lyte or Plasma-Lyte) only will follow Surviving Sepsis Campaign guidelines. Controls will receive 30 mL/kg (2100 mL in a typical 70 kg adult) of crystalloids within the first 3 hours. Subsequent resuscitation with balanced crystalloids will be titrated to the endpoints of resuscitation.

Treatment:

Drug: Balanced crystalloids