Septic ShockNCT03020407

The Randomized Controlled Trial of Inferior Vena Cava Ultrasound-guided Fluid Management in Septic Shock Resuscitation

A study testing IVC Ultrasound-guided, Antibiotics and Vasopressor in people with Septic Shock, run by Chulalongkorn University at 1 site in Thailand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The primary aim of this study is to evaluate the 30-day mortality outcome of the septic shock patients who are treated with ultrasound-assisted fluid management using change of the inferior vene cava (IVC) diameter during respiratory phases in the first 6 hours compared with those treated with "usual-care" strategy. 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?: IVC Ultrasound-guided, Antibiotics and Vasopressor
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 211 participants
Where: 1 siteThailand
Study dates: 18 Jan 2017to 31 Jul 2020
Phase: Interventional
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

Patient who attended the emergency department with septic shock (defined by those who require a vasopressor to maintain a mean arterial pressure (MAP) of 65 mm Hg or greater and whose serum lactate level greater than 2 mmol/L in the absence of hypovolemia.)

Who cannot join

1) Congestive pulmonary edema or known to have poor systolic cardiac function (left ventricular ejection fraction ≤ 40%).
2) Known to have right heart pathologies.
3) Having or suspected to have marked ascites, significant bowel dilatation or the conditions that can cause abdominal hypertension.
4) Body mass index ≥ 30 kg/square meter.
5) Having concomitant attack of severe airway disease (eg. Asthma, COPD) that may have confounded the IVC interpretation due to the positive intrathoracic pressure.
6) IVC can not be identified or its diameter cannot be measured correctly.

Show all 14Show fewer

7) Having end-stage renal diseases with or without dialysis.
8) Having non-infectious diseases as final diagnoses.
9) Pregnant women.
10) Have been referred or treated from other healthcare facility.
11) Having active hemorrhages.
12) Duplicated cases.
13) who had "do-not-resuscitate" living will.
14) Declined to consent.

Trial locations and contacts

1 site in 1 country.

Thailand1 site

Emergency Medicine Unit, King Chulalongkorn Memorial Hospital
Pathum Wan, Bangkok, 11130

Other trials in Thailand

About this study

Read the detailed description

Septic shock (SS) is globally prevalent in with high mortality rate.The current focuses on initial treatment of this condition emphasize on the early recognition, prompt administration of antibiotic, and restoration of hemodynamic with aggressive fluid resuscitation and vasopressor. Regarding the initial fluid therapy, administration of empirical crystalloid at the dose of 30 ml/kg is recommended in the guideline. The ultrasound-assisted management of shock patients has been introduced in the past decade and now is widely used. By using the measurement of inferior vena cava (IVC) diameter change during respiratory phases, physicians can predict the fluid responsiveness in the shock patients and tailor the fluid therapy during the resuscitation.Unfortunately, clinical outcome related to the use of this concept in SS resuscitation has not been well studied. Inadequate resuscitation with fluid therapy is related with higher mortality; however, fluid bolus or positive fluid balance that may result from "too aggressive" fluid administration is also associated with increased mortality in SS patients. The primary aim of this study was to evaluate the 30-day mortality outcome of the SS patients who were treated with ultrasound-assisted fluid management using change of the IVC during respiratory phases in the first 6 hours compared with those who were treated with "usual-care" strategy. The secondary outcomes were to compare the rate of the need for mechanical ventilation (MV) and renal replacement therapy (RRT) as well as the 6-hours lactate clearance and the change in Sequential Organ Failure (SOFA) score in 72 hours.

Conditions: Septic Shock
Being tested: IVC Ultrasound-guided, Antibiotics, Vasopressor
Keywords: Septic Shock, Inferior vene cava diameter, Resuscitation, Mortality
Medical subject headings: Shock, Septic

What participants receive

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

IVC Ultrasound-guidedProcedure or surgery
IVC is identified in longitudinal section in the subcostal area of a patient using the curvilinear probe of standard ultrasound. The selected area of IVC diameter measurement is set at 2 centimeters distal to the confluence of hepatic vein by M-mode coupled by two-dimensional mode on frozen screen images using the Sonosite® X-porte.
AntibioticsDrug
Also called Antimicrobials
Prompt empirical antibiotics will be given to the patients within one hour before the treatment allocation.
VasopressorDrug
Also called Norepinephrine, dopamine, epinephrine
The threshold to the need of a vasopressor is set at mean arterial pressure below 65 mmHg if a patient's condition does not response to the fluid therapy.

Study groups in NCT03020407
Study group	Role	What they receive
IVC Ultrasound-guided	Experimental	The treating physician will promptly assess the IVC diameter to obtain the collapsibility index (IVCCI) (or distensibility index, IVCDI) of an eligible patient. A previous study showed that IVCCI > 40% were strongly associated with fluid responsiveness. Accordingly, the patient will be given 10 ml/kg of bolus of 0.9% normal saline solution (NSS) each time when the IVCCI > 40% is discovered and serial measurements will be done after each intravenous bolus is achieved until the IVCCI < 40 % during our protocol. Prompt empirical antibiotics will be given to the patients within one hour before the treatment allocation. Receives: Procedure: IVC Ultrasound-guided; Drug: Antibiotics; Drug: Vasopressor
Usual care	No intervention	Patients will be promptly and empirically treated by 30 ml/kg loading of NSS in this treatment arm. After the NSS bolus, treatment with either the additional intravenous fluid or a vasopressor is given depended on physicians' discretion during the 6-hour study period. Prompt empirical antibiotics will be given to the patients within one hour before the treatment allocation.

What is being measured

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

30-day Mortality
30-day mortality related to septic shock
Measured: 30 day after randomization

Secondary outcomes (4)

Percentage Change of 6-hour Lactate
The percentage change in blood lactate at 6 hour after initiation of treatment, calculated by [(Initial blood lactate level at presentation - blood lactate level at 6 hours after treatment)/Initial blood lactate level at presentation] x 100%. The higher positive value means the more relative reduction of blood lactate after treatment from that of initial presentation and indicates a better clinical outcome.
Measured: 6 hours after treatment
6-hour Cumulative Amount of Intravenous Fluid (mL)
Cumulative amount of intravenous fluid (mL) during the first 6 hours after treatment.
Measured: 6 hours after treatment
72-hour Cumulative Amount of Intravenous Fluid (mL) After Treatment
Cumulative amount of intravenous fluid (mL) during the first 72 hours after treatment.
Measured: 72 hours after treatment
Change in Sequential Organ Failure Assessment (SOFA) Score in 72 Hours After Treatment
The change in Sequential Organ Failure Assessment (SOFA) score between the score at initial presentation and 72 hours after treatment, determined by SOFA score at presentation minus the SOFA score at 72 hours after treatment. The possible minimum and maximum value of the change in SOFA score are -24 and +24, respectively. The higher value means the more relative reduction in SOFA score at 72 hours and indicates a better clinical outcome.
Measured: 72 hours after treatment

Timeline

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

18 Jan 201731 Jul 2020

First posted13 Jan 2017 (estimated)
Study start18 Jan 2017
Primary completion30 Jun 2020
Study completion31 Jul 2020

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 Chulalongkorn UniversityThe 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 N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 211 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03020407
Sponsor's protocol ID: 589/59
Status last verified: Apr 2021
First submitted: 3 Jan 2017
Last updated: 22 Sep 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Musikatavorn K, Plitawanon P, Lumlertgul S, Narajeenron K, Rojanasarntikul D, Tarapan T, Saoraya J. Randomized Controlled Trial of Ultrasound-guided Fluid Resuscitation of Sepsis-Induced Hypoperfusion and Septic Shock. West J Emerg Med. 2021 Feb 10;22(2):369-378. doi: 10.5811/westjem.2020.11.48571.
PubMed 33856325

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

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Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
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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
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All Septic Shock trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Randomized Controlled Trial of Inferior Vena Cava Ultrasound-guided Fluid Management in Septic Shock Resuscitation
ClinicalTrials.gov ID: NCT03020407
Acronym / sponsor ID: 589/59
Conditions: Septic Shock
Keywords: Septic Shock, Inferior vene cava diameter, Resuscitation, Mortality
Study type: Interventional
Recruitment status: Completed
Enrolment: 211 participants (actual)
Lead sponsor: Chulalongkorn UniversityUniversity, hospital or other
Study start: 18 Jan 2017 (actual)
Primary completion: 30 Jun 2020 (actual)
Study completion: 31 Jul 2020 (actual)
First posted: 13 Jan 2017 (estimated)
Results: Posted 30 Aug 2021

Clinical summary

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

Detailed description

Study design

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

Arm	Type	Receives
IVC Ultrasound-guided	Experimental	Procedure: IVC Ultrasound-guided, Drug: Antibiotics, Drug: VasopressorThe treating physician will promptly assess the IVC diameter to obtain the collapsibility index (IVCCI) (or distensibility index, IVCDI) of an eligible patient. A previous study showed that IVCCI > 40% were strongly associated with fluid responsiveness. Accordingly, the patient will be given 10 ml/kg of bolus of 0.9% normal saline solution (NSS) each time when the IVCCI > 40% is discovered and serial measurements will be done after each intravenous bolus is achieved until the IVCCI < 40 % during our protocol. Prompt empirical antibiotics will be given to the patients within one hour before the treatment allocation.
Usual care	No intervention	–Patients will be promptly and empirically treated by 30 ml/kg loading of NSS in this treatment arm. After the NSS bolus, treatment with either the additional intravenous fluid or a vasopressor is given depended on physicians' discretion during the 6-hour study period. Prompt empirical antibiotics will be given to the patients within one hour before the treatment allocation.

Who may qualify

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

Key inclusion criteria (1 listed)

Patient who attended the emergency department with septic shock (defined by those who require a vasopressor to maintain a mean arterial pressure (MAP) of 65 mm Hg or greater and whose serum lactate level greater than 2 mmol/L in the absence of hypovolemia.)

Key exclusion criteria (14 listed)

1) Congestive pulmonary edema or known to have poor systolic cardiac function (left ventricular ejection fraction ≤ 40%).
2) Known to have right heart pathologies.
3) Having or suspected to have marked ascites, significant bowel dilatation or the conditions that can cause abdominal hypertension.
4) Body mass index ≥ 30 kg/square meter.
5) Having concomitant attack of severe airway disease (eg. Asthma, COPD) that may have confounded the IVC interpretation due to the positive intrathoracic pressure.

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
IVC Ultrasound-guidedIVC is identified in longitudinal section in the subcostal area of a patient using the curvilinear probe of standard ultrasound. The selected area of IVC diameter measurement is set at 2 centimeters distal to the confluence of hepatic vein by M-mode coupled by two-dimensional mode on frozen screen images using the Sonosite® X-porte.	Procedure or surgery	IVC Ultrasound-guided
AntibioticsAlso: AntimicrobialsPrompt empirical antibiotics will be given to the patients within one hour before the treatment allocation.	Drug	IVC Ultrasound-guided
VasopressorAlso: Norepinephrine, dopamine, epinephrineThe threshold to the need of a vasopressor is set at mean arterial pressure below 65 mmHg if a patient's condition does not response to the fluid therapy.	Drug	IVC Ultrasound-guided

Primary outcome

30-day Mortality
Time frame: 30 day after randomization
30-day mortality related to septic shock

4 secondary outcomes

Percentage Change of 6-hour Lactate
Time frame: 6 hours after treatment
6-hour Cumulative Amount of Intravenous Fluid (mL)
Time frame: 6 hours after treatment
72-hour Cumulative Amount of Intravenous Fluid (mL) After Treatment
Time frame: 72 hours after treatment
Change in Sequential Organ Failure Assessment (SOFA) Score in 72 Hours After Treatment
Time frame: 72 hours after treatment

Results and safety

Results posted to the registry on 30 Aug 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
IVC Ultrasound-guided	105	101
Usual Care	106	101

Primary outcome: 30-day Mortality

Time frame: 30 day after randomization. Count of participants. Unit: Participants

Measure	IVC Ultrasound-guided n = 101	Usual Care n = 101
Value	20	19

4 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
IVC Ultrasound-guided	31 of 101 (30.7%)	4 of 101 (4%)	20 of 101
Usual Care	35 of 101 (34.7%)	2 of 101 (2%)	19 of 101

Limitations and caveats (from the sponsor): This study was conducted with the specific study protocol at a single, tertiary-care hospital. Second, physicians should use cautious clinical judgment or different approaches in different types of patients. The interpersonal variation and sampling position may have affected the consistency of IVC diameter measurement.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 33856325Musikatavorn K, Plitawanon P, Lumlertgul S, Narajeenron K, Rojanasarntikul D, Tarapan T, Saoraya J. Randomized Controlled Trial of Ultrasound-guided Fluid Resuscitation of Sepsis-Induced Hypoperfusion and Septic Shock. West J Emerg Med. 2021 Feb 10;22(2):369-378. doi: 10.5811/westjem.2020.11.48571.
Individual participant dataSharing planned: No

Related trials for Septic Shock

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

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.

Khrongwong Musikatavorn, MD principal investigator

Emergency Unit, Faculty of Medicine, Chulalongkorn Hospital

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

Questions about this trial

What is this clinical trial studying?

A study testing IVC Ultrasound-guided, Antibiotics and Vasopressor in people with Septic Shock, run by Chulalongkorn University at 1 site in Thailand.

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 1 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: finished, as of the sponsor's last update on 22 Sep 2021. 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 Thailand. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Aug 2021). 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?

30-day Mortality (time frame: 30 day after randomization). 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 NCT03020407, 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 22 Sep 2021; AzTrials last refreshed its copy on 7 Nov 2026.