Resuscitation With Plasma in Surgical and Trauma Patients With Septic Shock

April 11, 2022 updated by: Lillian Kao, The University of Texas Health Science Center, Houston
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • The University of Texas Health Science Center at Houston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: initial resuscitation with 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.
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.
Active Comparator: initial resuscitation with 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.
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Glycocalyx Breakdown as Assessed by Syndecan-1 Levels
Time Frame: 0, 2, end of initial bolus of fluid administration (about 3 hours), 12, and at 24 hours
0, 2, end of initial bolus of fluid administration (about 3 hours), 12, and at 24 hours
Glycocalyx Breakdown and Endothelial Leakage as Assessed by Soluble Thrombomodulin (sTM)
Time Frame: 0, 2, end of initial bolus of fluid administration (about 3 hours), 12, and 24 hours
0, 2, end of initial bolus of fluid administration (about 3 hours), 12, and 24 hours
Endothelial Leakage as Assessed by Soluble FMS-like Tyrosine Kinase-1 (sFLT-1)
Time Frame: 0, 2, end of initial bolus of fluid administration(about 3 hours), 12, and 24 hours
0, 2, end of initial bolus of fluid administration(about 3 hours), 12, and 24 hours
Endothelial Leakage and Inflammation as Assessed by Vascular Endothelial Growth Factor (VEGF)
Time Frame: 0, 2, end of initial bolus of fluid administration (about 3 hours), 12, and 24 hours
0, 2, end of initial bolus of fluid administration (about 3 hours), 12, and 24 hours
Sympatho-adrenal Activation as Assessed by Norepinephrine (NE)
Time Frame: 0, 2, end of initial bolus of fluid administration (about 3 hours), 12, and 24 hours
0, 2, end of initial bolus of fluid administration (about 3 hours), 12, and 24 hours
Sympatho-adrenal Activation as Assessed by Epinephrine (Epi)
Time Frame: 0, 2, end of initial bolus of fluid administration (about 3 hours), 12, and 24 hours
0, 2, end of initial bolus of fluid administration (about 3 hours), 12, and 24 hours
Inflammation as Assessed by Soluble Receptor for Advanced Glycation Endproduct (sRAGE)
Time Frame: 0, 2, end of initial bolus of fluid administration, 12, and 24 hours
0, 2, end of initial bolus of fluid administration, 12, and 24 hours
Inflammation as Assessed by High Mobility Group Protein-1 (HMGB-1)
Time Frame: 0, 2, end of initial bolus of fluid administration, 12, and 24 hours
0, 2, end of initial bolus of fluid administration, 12, and 24 hours
Inflammation as Assessed by Interleukin-6 (IL-6)
Time Frame: 0, 2, end of initial bolus of fluid administration (about 3 hours), 12, and 24 hours
0, 2, end of initial bolus of fluid administration (about 3 hours), 12, and 24 hours
Inflammation as Assessed by Interleukin-8 (IL-8)
Time Frame: 0, 2, end of initial bolus of fluid administration (about 3 hours) , 12, and 24 hours
0, 2, end of initial bolus of fluid administration (about 3 hours) , 12, and 24 hours
Inflammation as Assessed by Interleukin-10 (IL-10)
Time Frame: 0, 2, end of initial bolus of fluid administration (about 3 hours), 12, and 24 hours
0, 2, end of initial bolus of fluid administration (about 3 hours), 12, and 24 hours
Inflammation as Assessed by Interleukin-1α (IL-1α)
Time Frame: 0, 2, end of initial bolus of fluid administration (about 3 hours), 12, and 24 hours
0, 2, end of initial bolus of fluid administration (about 3 hours), 12, and 24 hours
Inflammation as Assessed by Interleukin-1β (IL-1β)
Time Frame: 0, 2, end of initial bolus of fluid administration (about 3 hours), 12, and 24 hours
0, 2, end of initial bolus of fluid administration (about 3 hours), 12, and 24 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Total Volume of Fluid Required for Resuscitation After the Initial Bolus of Either Plasma or Crystalloids
Time Frame: First 24 hours after initiation of fluid resuscitation
Data were not collected for 1 participant in the initial resuscitation with plasma arm.
First 24 hours after initiation of fluid resuscitation
Time Until Lactate Normalization
Time Frame: First 24 hours after initiation of fluid resuscitation
First 24 hours after initiation of fluid resuscitation
Time on Vasopressors
Time Frame: First 30 days after initiation of fluid resuscitation
First 30 days after initiation of fluid resuscitation
Number of Days on Ventilator Support
Time Frame: First 30 days after initiation of fluid resuscitation
First 30 days after initiation of fluid resuscitation
Number of Intensive Care Unit (ICU)-Free Days
Time Frame: First 30 days after initiation of fluid resuscitation
First 30 days after initiation of fluid resuscitation
Number of Hospital Days
Time Frame: From the time of initiation of fluid resuscitation to the time of hospital discharge (up to about 170 days)
From the time of initiation of fluid resuscitation to the time of hospital discharge (up to about 170 days)
Mortality
Time Frame: First 30 days after initiation of fluid resuscitation
First 30 days after initiation of fluid resuscitation
Number of Participants With Acute Lung Injury
Time Frame: First 30 days after initiation of fluid resuscitation
First 30 days after initiation of fluid resuscitation
Number of Participants With Acute Kidney Injury
Time Frame: First 30 days after initiation of fluid resuscitation
First 30 days after initiation of fluid resuscitation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Texas Health Science Center, Houston

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Shuyan Wei, MD, The University of Texas Health Science Center, Houston

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 26, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 17, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 16, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 1, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 1, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 8, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 13, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 11, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HSC-MS-17-0714

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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