Vexus-guided Fluid Management in Patients With Septic Shock After the Resuscitation Phase

Septic Shock Clinical Trial

— VEXUS  

Official title:

Vexus-guided Fluid Management in Patients With Septic Shock After the Resuscitation Phase

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06227702
• Other study ID #: VEXUS
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2024
• Est. completion date: February 28, 2026

Study information

• Verified date: January 2024
• Source: Federal University of São Paulo
• Contact: Flavia Machado
• Phone: +55 11 996552410
• Email: frmachado[@]unifesp.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: February 28, 2026
• Est. primary completion date: February 28, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Critically Ill Patients
• Septic Shock
• Shock
• Shock, Septic

Intervention

Other:
• Fluid management according to Venous Excess Ultrasound (VExUS) Score
Management of furosemide intravenous infusion according to VeXus results

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Federal University of São Paulo	BRICNET - Brazilian Research in Intensive Care Network

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	intervention stopping criteria: hypokalemia, hypernatremia and metabolic acidosis	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
Primary	Hierarchy outcome: death in the ICU, need for renal replacement therapy during ICU stay and serum creatinine value on the third day after randomization	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: Death in ICU; Need for renal replacement therapy during ICU stay; Serum creatinine value on the third day after randomization	three days
Secondary	fluid balance	fluid balance during the first three days	three days
Secondary	PaO2/FiO2	worst PaO2/FiO2 during the first three days	three days