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

NCT06227702 | Not Yet Recruiting DMC

• 1 other identifier: VEXUS
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Critically Ill Patients; Septic Shock

Keywords

vexus; fluid management; deresuscitation; deaccumulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• fluid balance

  three days

• PaO2/FiO2

  three days

Other Outcomes (1)

• intervention stopping criteria: hypokalemia, hypernatremia and metabolic acidosis

  Three days

Study Arms (2)

VeXus

ACTIVE COMPARATOR

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

Other: Fluid management according to Venous Excess Ultrasound (VExUS) Score

Usual care

NO INTERVENTION

The usual care arm will follow the management protocols of the unit which are based in the Surviving Sepsis Campaign guidelines.

Interventions

Fluid management according to Venous Excess Ultrasound (VExUS) Score OTHER

Management of furosemide intravenous infusion according to VeXus results

VeXus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal University of São Paulo: lead
• BRICNET - Brazilian Research in Intensive Care Network: collaborator

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Flavia Machado

  Federal University of São Paulo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Flavia Machado

CONTACT

+55 11 996552410; frmachado@unifesp.br

ALVES IZABELA

CONTACT

+55 27 997823282; izabelasinara@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Model Details: randomized 1:1

Study Record Dates

• First Submitted: January 18, 2024
• First Posted: January 29, 2024
• Study Start: February 1, 2024
• Primary Completion: February 28, 2026
• Study Completion: February 28, 2026
• Last Updated: February 2, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data will be available after 6 months of publication and for 5 years
• Access Criteria: EC approval