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

Chulalongkorn University

Status: Completed

Conditions: Septic Shock

Treatments: Drug: Antibiotics; Drug: Vasopressor; Procedure: IVC Ultrasound-guided

Study type: Interventional

Funder types: Other

Identifiers

NCT03020407

589/59

Details and patient eligibility

About

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.

Full 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.

Enrollment: 211 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.)

Exclusion criteria

• 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.
• 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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211 participants in 2 patient groups

IVC Ultrasound-guided

Experimental group

Description:

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.

Treatment:

Drug: Vasopressor

Procedure: IVC Ultrasound-guided

Drug: Antibiotics

Usual care

No Intervention group

Description:

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.