Septic ShockPhase 2NCT03366220

Resuscitation With Plasma in Surgical and Trauma Patients With Septic Shock

A Phase 2 study testing Plasma and Balanced crystalloids in people with Septic Shock, run by The University of Texas Health Science Center, Houston at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Septic Shock
What is being tested?: Plasma and Balanced crystalloids
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 1 siteUnited States
Study dates: 26 Mar 2018to 16 Oct 2019
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Show all 14Show fewer

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 locations and contacts

1 site in 1 country.

United States1 site

The University of Texas Health Science Center at Houston
Houston, Texas, 77030

Other trials in United States

About this study

Conditions: Septic Shock
Being tested: Plasma, Balanced crystalloids
Medical subject headings: Shock, Septic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PlasmaDrug
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 crystalloidsDrug
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.

Study groups in NCT03366220
Study group	Role	What they receive
initial resuscitation with plasma	Experimental	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. Receives: Drug: Plasma
initial resuscitation with balanced crystalloids	Active comparator	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. Receives: Drug: Balanced crystalloids

What is being measured

The primary outcome is the main question the study is designed to answer.

Glycocalyx Breakdown as Assessed by Syndecan-1 Levels
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 0, 2, end of initial bolus of fluid administration (about 3 hours), 12, and 24 hours
Sympatho-adrenal Activation as Assessed by Norepinephrine (NE)
Measured: 0, 2, end of initial bolus of fluid administration (about 3 hours), 12, and 24 hours
Sympatho-adrenal Activation as Assessed by Epinephrine (Epi)
Measured: 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)
Measured: 0, 2, end of initial bolus of fluid administration, 12, and 24 hours
Inflammation as Assessed by High Mobility Group Protein-1 (HMGB-1)
Measured: 0, 2, end of initial bolus of fluid administration, 12, and 24 hours
Inflammation as Assessed by Interleukin-6 (IL-6)
Measured: 0, 2, end of initial bolus of fluid administration (about 3 hours), 12, and 24 hours
Inflammation as Assessed by Interleukin-8 (IL-8)
Measured: 0, 2, end of initial bolus of fluid administration (about 3 hours) , 12, and 24 hours
Inflammation as Assessed by Interleukin-10 (IL-10)
Measured: 0, 2, end of initial bolus of fluid administration (about 3 hours), 12, and 24 hours
Inflammation as Assessed by Interleukin-1α (IL-1α)
Measured: 0, 2, end of initial bolus of fluid administration (about 3 hours), 12, and 24 hours
Inflammation as Assessed by Interleukin-1β (IL-1β)
Measured: 0, 2, end of initial bolus of fluid administration (about 3 hours), 12, and 24 hours

Secondary outcomes (9)

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.
Measured: First 24 hours after initiation of fluid resuscitation
Time Until Lactate Normalization
Measured: First 24 hours after initiation of fluid resuscitation
Time on Vasopressors
Measured: First 30 days after initiation of fluid resuscitation
Number of Days on Ventilator Support
Measured: First 30 days after initiation of fluid resuscitation
Number of Intensive Care Unit (ICU)-Free Days
Measured: First 30 days after initiation of fluid resuscitation
Number of Hospital Days
Measured: From the time of initiation of fluid resuscitation to the time of hospital discharge (up to about 170 days)
Mortality
Measured: First 30 days after initiation of fluid resuscitation
Number of Participants With Acute Lung Injury
Measured: First 30 days after initiation of fluid resuscitation
Number of Participants With Acute Kidney Injury
Measured: First 30 days after initiation of fluid resuscitation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Mar 201816 Oct 2019

First posted8 Dec 2017
Study start26 Mar 2018
Primary completion17 Sep 2019
Study completion16 Oct 2019

Why it stopped: The study was halted early due to low patient accrual secondary to COVID-19 and significant heterogeneity in clinical manifestations of sepsis precluding enrollment.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Septic ShockStudies of the same condition, open and under way.
More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03366220
Sponsor's protocol ID: HSC-MS-17-0714
Status last verified: Apr 2022
First submitted: 1 Dec 2017
Last updated: 13 Apr 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

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.
PubMed 30271882

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
ICU-SUCCEED for Survivors of Acute Respiratory Failure and Their Caregivers
Acute Respiratory Failure, Critical Illness
Not yet recruitingObservational study
Longitudinal Trajectories of Myocardial Work in Patients With Sepsis
Sepsis, Septic Shock Hyperdynamic
RecruitingObservational study
Immunothrombosis With Septic Shock Undergoing Renal Replacement Therapy With the OXIRIS Membrane
Sepsis

All Septic Shock trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Resuscitation With Plasma in Surgical and Trauma Patients With Septic Shock
ClinicalTrials.gov ID: NCT03366220
Acronym / sponsor ID: HSC-MS-17-0714
Conditions: Septic Shock
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: The study was halted early due to low patient accrual secondary to COVID-19 and significant heterogeneity in clinical manifestations of sepsis precluding enrollment.
Enrolment: 16 participants (actual)
Lead sponsor: The University of Texas Health Science Center, HoustonUniversity, hospital or other
Study start: 26 Mar 2018 (actual)
Primary completion: 17 Sep 2019 (actual)
Study completion: 16 Oct 2019 (actual)
First posted: 8 Dec 2017 (actual)
Results: Posted 13 Apr 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
initial resuscitation with plasma	Experimental	Drug: PlasmaInitial 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.
initial resuscitation with balanced crystalloids	Active comparator	Drug: Balanced crystalloidsUsual 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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.

Key exclusion criteria (14 listed)

Pregnancy
Prisoners
Traumatic brain injury
Evidence of ongoing hemorrhage, history of congenital bleeding disorders, therapeutic anticoagulation
History of myocardial infarction or congestive heart failure

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PlasmaInitial 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	initial resuscitation with plasma
Balanced crystalloidsUsual 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	initial resuscitation with balanced crystalloids

Primary outcome

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
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
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
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
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
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
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
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
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
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
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
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
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

9 secondary outcomes

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
Time Until Lactate Normalization
Time frame: First 24 hours after initiation of fluid resuscitation
Time on Vasopressors
Time frame: First 30 days after initiation of fluid resuscitation
Number of Days on Ventilator Support
Time frame: 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
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)
Mortality
Time frame: 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
Number of Participants With Acute Kidney Injury
Time frame: First 30 days after initiation of fluid resuscitation

Results and safety

Results posted to the registry on 13 Apr 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Initial Resuscitation With Plasma	4	4
Initial Resuscitation With Balanced Crystalloids	4	4

Primary outcome: 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. Mean (Standard Deviation). Unit: ng/mL

Measure	Initial Resuscitation With Plasma n = 4	Initial Resuscitation With Balanced Crystalloids n = 4
0 hours	260.87 (455.79)	390.67 (169.66)
2 hours	294.03 (499.12)	383.53 (122.26)
end of initial bolus of fluid administration (about 3 hours)	278.22 (456.24)	337.37 (220.03)
12 hours	291.28 (496.24)	350.43 (196.62)
24 hours	241.16 (349.15)	285.34 (45.10)

Population analysed: Data was not collected at end of initial bolus of fluid administration (about 3 hours) and 24 hours for one participant in the initial resuscitation with balanced crystalloids arm.

Primary outcome: 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. Mean (Standard Deviation). Unit: ng/mL

Measure	Initial Resuscitation With Plasma n = 4	Initial Resuscitation With Balanced Crystalloids n = 4
0 hours	22.44 (14.94)	21.29 (12.22)
2 hours	22.06 (17.19)	21.50 (11.66)
end of initial bolus of fluid administration (about 3 hours)	21.87 (15.88)	23.38 (14.28)
12 hours	21.13 (12.59)	22.10 (11.86)
24 hours	25.69 (21.02)	24.43 (12.78)

Population analysed: Data was not collected at end of initial bolus of fluid administration (about 3 hours) and at 24 hours for one participant in the initial resuscitation with balanced crystalloids arm.

Primary outcome: 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

Population analysed: Data was not collected for this outcome measure.

Primary outcome: 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. Mean (Standard Deviation). Unit: pg/mL

Measure	Initial Resuscitation With Plasma n = 4	Initial Resuscitation With Balanced Crystalloids n = 4
0 hours	108.35 (0)	61.6 (0)
2 hours	76.63 (0)	97.44 (0)
end of initial bolus of fluid administration (about 3 hours)	48.02 (0)	32.93 (0)
12 hours	171.29 (0)	–
24 hours	97.44 (0)	215.23 (0)

Population analysed: In the plasma arm, sample levels were out of range and thus no value could be obtained for 3 participants at all time points. In the balanced crystalloids arm, sample levels were out of range and thus no value could be obtained for 3 participants at 0, 2, and 12 hours; for 2 at about 3 hours and at 24 hours; and for all 4 at 12 hours--in addition to those with sample levels out of range, there was 1 other participant for whom no data at all were collected at 3 hours and 24 hours.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: 30 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Initial Resuscitation With Plasma	4 of 4 (100%)	0 of 4 (0%)	1 of 4
Initial Resuscitation With Balanced Crystalloids	4 of 4 (100%)	0 of 4 (0%)	1 of 4

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30271882Wei 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Shuyan Wei, MD principal investigator

The University of Texas Health Science Center, Houston

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Plasma and Balanced crystalloids in people with Septic Shock, run by The University of Texas Health Science Center, Houston at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 13 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03366220, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2022.