Resuscitation With Plasma in Surgical and Trauma Patients With Septic Shock

Septic Shock Clinical Trial

Official title:

Resuscitation With Plasma in Surgical and Trauma Patients With Septic Shock

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03366220
• Other study ID #: HSC-MS-17-0714
• Status: Terminated
• Phase: Phase 2
• Start date: March 26, 2018
• Est. completion date: October 16, 2019

Study information

• Verified date: April 2022
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: October 16, 2019
• Est. primary completion date: September 17, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Septic Shock
• Shock
• Shock, Septic

Intervention

Drug:
• Plasma
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.
• Balanced crystalloids
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.

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycocalyx Breakdown as Assessed by Syndecan-1 Levels		0, 2, end of initial bolus of fluid administration (about 3 hours), 12, and at 24 hours
Primary	Glycocalyx Breakdown and Endothelial Leakage as Assessed by Soluble Thrombomodulin (sTM)		0, 2, end of initial bolus of fluid administration (about 3 hours), 12, and 24 hours
Primary	Endothelial Leakage as Assessed by Soluble FMS-like Tyrosine Kinase-1 (sFLT-1)		0, 2, end of initial bolus of fluid administration(about 3 hours), 12, and 24 hours
Primary	Endothelial Leakage and Inflammation as Assessed by Vascular Endothelial Growth Factor (VEGF)		0, 2, end of initial bolus of fluid administration (about 3 hours), 12, and 24 hours
Primary	Sympatho-adrenal Activation as Assessed by Norepinephrine (NE)		0, 2, end of initial bolus of fluid administration (about 3 hours), 12, and 24 hours
Primary	Sympatho-adrenal Activation as Assessed by Epinephrine (Epi)		0, 2, end of initial bolus of fluid administration (about 3 hours), 12, and 24 hours
Primary	Inflammation as Assessed by Soluble Receptor for Advanced Glycation Endproduct (sRAGE)		0, 2, end of initial bolus of fluid administration, 12, and 24 hours
Primary	Inflammation as Assessed by High Mobility Group Protein-1 (HMGB-1)		0, 2, end of initial bolus of fluid administration, 12, and 24 hours
Primary	Inflammation as Assessed by Interleukin-6 (IL-6)		0, 2, end of initial bolus of fluid administration (about 3 hours), 12, and 24 hours
Primary	Inflammation as Assessed by Interleukin-8 (IL-8)		0, 2, end of initial bolus of fluid administration (about 3 hours) , 12, and 24 hours
Primary	Inflammation as Assessed by Interleukin-10 (IL-10)		0, 2, end of initial bolus of fluid administration (about 3 hours), 12, and 24 hours
Primary	Inflammation as Assessed by Interleukin-1a (IL-1a)		0, 2, end of initial bolus of fluid administration (about 3 hours), 12, and 24 hours
Primary	Inflammation as Assessed by Interleukin-1ß (IL-1ß)		0, 2, end of initial bolus of fluid administration (about 3 hours), 12, and 24 hours
Secondary	Total Volume of Fluid Required for Resuscitation After the Initial Bolus of Either Plasma or Crystalloids	Data were not collected for 1 participant in the initial resuscitation with plasma arm.	First 24 hours after initiation of fluid resuscitation
Secondary	Time Until Lactate Normalization		First 24 hours after initiation of fluid resuscitation
Secondary	Time on Vasopressors		First 30 days after initiation of fluid resuscitation
Secondary	Number of Days on Ventilator Support		First 30 days after initiation of fluid resuscitation
Secondary	Number of Intensive Care Unit (ICU)-Free Days		First 30 days after initiation of fluid resuscitation
Secondary	Number of Hospital Days		From the time of initiation of fluid resuscitation to the time of hospital discharge (up to about 170 days)
Secondary	Mortality		First 30 days after initiation of fluid resuscitation
Secondary	Number of Participants With Acute Lung Injury		First 30 days after initiation of fluid resuscitation
Secondary	Number of Participants With Acute Kidney Injury		First 30 days after initiation of fluid resuscitation