- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06227702
Vexus-guided Fluid Management in Patients With Septic Shock After the Resuscitation Phase (VEXUS)
It is well recognized the association between fluid volume administered and positive fluid balance with adverse outcomes . Active fluid removal is widely practiced in an attempt to mitigate this potential damage. However, it is not clear which is the best approach for the post-resuscitation phase in critically ill patients. In this context, Point-of-Care ultrasound (POCUS) through Venous Excess Ultrasound (VExUS) would allow the assessment of the degree of venous congestion, through the visualization of vascular anatomy and blood velocity using Doppler, being potentially useful to guide fluid removal. The investigators will evaluate whether fluid management after the initial phase of VExUS-guided resuscitation is able to improve outcomes compared to usual therapy in patients with septic shock.
This is a single center, prospective, open and randomized clinical study in which patients admitted to intensive care will be included after the first 24 hours of resuscitation. A total of 200 patients will be randomized either to volume management guided by VExUS or to the standard therapy arm as per usual practice.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
All patients hospitalized or admitted to the intensive care unit with septic shock will be screened for eligibility. Patients will be randomized using an electronic system (RedCap) to receive or not the intervention.
After 24 hours of shock onset, patients without hypoperfusion after informed consent will be allocated into two groups. In intervention arm wil be assessed by VeXus. Patients without signs of venous congestion (VeXus = 0) will continue to be observed every 6 hours. In patients with VeXus ≥1, continuous infusion of intravenous furosemide will be initiated. During the first 48 hours after inclusion in the study, patients will be evaluated for the intervention every 6 to 8 hours: Time 1 (T1) at randomization, T2 after 6 hours of T1, T3 after 6 hours of T2 and every 6 to 8 hours later. At these times, in patients with a reduction of at least one point in VeXus, the furosemide infusion will be maintained. If there is a worsening or no improvement of at least one point in the VeXus, the infusion will be doubled.In patients where there are signs of hypoperfusion, furosemide therapy will be discontinued. The administration of furosemide will also be interrupted in patients who develop serum sodium > 160 mEq/L; metabolic alkalosis (bicarbonate > 35 mEq/L) or potassium < 3mEq/L. In patients randomized to the usual therapy group, the attending physician will decide whether to prescribe furosemide or not according to his assessment without any defined time criteria. All other aspects of care will be managed according to routine unit protocols
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Flavia Machado
- Phone Number: +55 11 996552410
- Email: frmachado@unifesp.br
Study Contact Backup
- Name: ALVES IZABELA
- Phone Number: +55 27 997823282
- Email: izabelasinara@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age over 18 years old.
- Hospitalization in ICU for at least 48 hours.
- Patient in septic shock for at least 24 hours and clinically stable defined by mean arterial pressure ≥ 65 mmHg and maximum infusion of 0.20 μg/kg/min of norepinephrine and lactate < 4.0 mmol/L.
- Signed informed consent
Exclusion Criteria:
- Patients in use of more than one vasopressor
- Known right ventricle dysfunction
- Indication to use furosemide for other reasons
- Hypernatremia (Na >160 mmol/L)
- Advanced acute kidney injury(KDIGO 3)
- Current renal replacement therapy
- Anuria for ≥ 6 hours
- Hepatorenal syndrome
- Patients in palliative care
- Furosemide allergy.
- Rhabdomyolysis.
- Major burn
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: VeXus
Patients in the intervention arm wil be assessed by VeXus.
Patients without signs of venous congestion (VeXus = 0) will be observed every 6 hours.
In patients with VeXus ≥1, continuous infusion of intravenous furosemide will be initiated.
During the first 48 hours, furosemide infusion will be adjusted according to VeXus .
All other aspects of care will be managed according to routine unit protocols
|
Management of furosemide intravenous infusion according to VeXus results
|
No Intervention: Usual care
The usual care arm will follow the management protocols of the unit which are based in the Surviving Sepsis Campaign guidelines.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hierarchy outcome: death in the ICU, need for renal replacement therapy during ICU stay and serum creatinine value on the third day after randomization
Time Frame: three days
|
The outcome of the study will be assessed by the win rate ("Win ratio WR) between the intervention arm and the usual care arm defined by the occurrence in hierarchical order of one of the following events:
|
three days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
fluid balance
Time Frame: three days
|
fluid balance during the first three days
|
three days
|
PaO2/FiO2
Time Frame: three days
|
worst PaO2/FiO2 during the first three days
|
three days
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
intervention stopping criteria: hypokalemia, hypernatremia and metabolic acidosis
Time Frame: Three days
|
As safety outcomes, we will assess the following events potentially attributed to intervention: Na >160 mEq/L; metabolic alkalosis (bicarbonate> 35 mEq/L), potassium <3mEq/L
|
Three days
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Flavia Machado, Federal University of São Paulo
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VEXUS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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