De-resuscitation Informed by Ultrasound for Patients With Sepsis

NCT ID: NCT04921319

Last Updated: 2021-06-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 152 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-26
• Study Completion Date: 2022-07-30

Brief Summary

Randomized, unblinded clinical trial of 152 critically ill patients with sepsis admitted to the intensive care unit. The primary determine if using the Venous Excess Ultrasound Score (VExUS) to guide fluid deresuscitation in critically ill patients with sepsis reduces net fluid balance at 5 days as compared to usual care.

Detailed Description

Physicians can assess venous congestions with point of care ultrasound of intraabdominal veins using the venous excess in ultrasound score (VExUS), which has been shown to predict the harmful effects of volume overload. We seek to determine if VExUS-guided deresuscitation reduces the fluid balance in critically ill patients with sepsis as compared to usual care. This score compiles findings from the inferior vena cava, hepatic vein Doppler waveform, portal vein Doppler waveform, and intrarenal vein Doppler waveform:

Grade 0: IVC < 2cm, normal pattern in flow patterns of hepatic, portal, and intrarenal veins Grade 1: IVC ≥ 2cm, normal patterns or mild abnormalities in flow patterns of hepatic, portal, and intrarenal veins.

Grade 2: IVC ≥ 2cm, severe venous flow pattern in one among hepatic, portal, and intrarenal veins.

Grade 3: IVC ≥ 2cm, severe venous flow pattern in multiple among hepatic, portal, and intrarenal veins.

After informed consent, subjects will be randomized in a 1:1 ratio to the VExUS-guided intervention arm vs control arm. Subjects in both arms will undergo daily ultrasound, and the investigator will calculate the VExUS immediately after ultrasounds are obtained.

Conditions

Sepsis; Septic Shock; Sepsis, Severe; Volume Overload

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

VExUS-Guided Arm

Will receive 24 hour fluid balance target based on daily VExUS score.

Group Type: EXPERIMENTAL

VExUS score

Intervention Type: DIAGNOSTIC_TEST

The care team will be informed of the VExUS immediately after the ultrasound is performed and given a suggested target for the following 24 hours as follows:

• VExUS 0: "The patient will likely tolerate more fluid if clinically needed."
• VExUS 1: "The patient has evidence of mild venous congestion. The investigators recommend targeting a net neutral or negative fluid balance with diuresis."
• VExUS 2-3: "The patient has evidence of moderate to severe venous congestion. The investigators recommend targeting a fluid balance of negative 1-2L with diuresis." If the investigator cannot obtain ultrasound images of sufficient quality to calculate VExUS, the care team will be informed that there is no recommendation for that subject on that day.

Usual Care Control Arm

Treating team will be blinded to results of daily VExUS score and will set 24 hour fluid balance target based on usual care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

VExUS score

The care team will be informed of the VExUS immediately after the ultrasound is performed and given a suggested target for the following 24 hours as follows:

• VExUS 0: "The patient will likely tolerate more fluid if clinically needed."
• VExUS 1: "The patient has evidence of mild venous congestion. The investigators recommend targeting a net neutral or negative fluid balance with diuresis."
• VExUS 2-3: "The patient has evidence of moderate to severe venous congestion. The investigators recommend targeting a fluid balance of negative 1-2L with diuresis." If the investigator cannot obtain ultrasound images of sufficient quality to calculate VExUS, the care team will be informed that there is no recommendation for that subject on that day.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• 1. Must be suspected by the treating physician to have sepsis as the primary cause of their acute illness as exhibited by 2 or more of the following Systemic Inflammatory Response Syndrome (SIRS) criteria:

1. Temperature of > 38 C or < 36 C

2. Heart rate of > 90/min

3. Respiratory rate of > 20/min or PaCO2 < 32 mm Hg

4. White blood cell count > 12000/mm3 or < 4000/mm3 or >10% immature bands. 2. Known or suspected infection at the time of screening 3. Admission to the ICU for <24 hours

Since approximately 12% of patients ultimately diagnosed with sepsis do not meet SIRS criteria, SIRS negative patients will be eligible for the study if the treating physician makes a clinical diagnosis of severe sepsis or septic shock.

Exclusion Criteria

1. Patients with conditions that may interfere with portal Doppler assessments such as cirrhosis or portal thrombosis

2. Patients with severe chronic kidney disease (estimated glomerular filtration rate<15 mL/min per 1.73 m2 calculated using the Modified Diet in Renal Disease formula).

3. Age < 18 years

4. Active atrial fibrillation or atrial flutter

5. Hemodynamic instability due to active hemorrhage

6. Acute cerebral vascular event

7. Acute coronary syndrome (excluding elevated troponin thought to be from demand ischemia)

8. Acute pulmonary edema

9. Status asthmaticus

10. Drug overdose

11. Injury from burn or trauma

12. Status epilepticus

13. Indication for immediate surgery

14. Received CPR within 24 hours of enrollment

15. Pregnancy

16. Incarceration.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Miriam Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Keith Corl, MD

Role: PRINCIPAL_INVESTIGATOR

Rhode Island Hospital / The Miriam Hospital

Locations

The Miriam Hospital

Providence, Rhode Island, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Christopher F Allison, MD

Role: CONTACT

callison@lifespan.org

401-793-4501

Facility Contacts

Keith Corl, MD

Role: primary

keith_corl@brown.edu

References

Beaubien-Souligny W, Rola P, Haycock K, Bouchard J, Lamarche Y, Spiegel R, Denault AY. Quantifying systemic congestion with Point-Of-Care ultrasound: development of the venous excess ultrasound grading system. Ultrasound J. 2020 Apr 9;12(1):16. doi: 10.1186/s13089-020-00163-w.

Reference Type: BACKGROUND

PMID: 32270297 (View on PubMed)

Other Identifiers

1694487-1

Identifier Type: -

Identifier Source: org_study_id