Clinical trial NCT03020407: The Randomized Controlled Trial of Inferior Vena Cava Ultrasound-guided Fluid Management in Septic Shock Resuscitation
Official title: The Randomized Controlled Trial of Inferior Vena Cava Ultrasound-guided Fluid Management in Septic Shock Resuscitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Septic Shock
Keywords: Septic Shock
Inferior vene cava diameter
Resuscitation
Mortality
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2017-01-13
Enrollment: 211
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: 30-day Mortality
timeFrame: 30 day after randomization
Secondary outcomes:
measure: Percentage Change of 6-hour Lactate
timeFrame: 6 hours after treatment
measure: 6-hour Cumulative Amount of Intravenous Fluid (mL)
timeFrame: 6 hours after treatment
measure: 72-hour Cumulative Amount of Intravenous Fluid (mL) After Treatment
timeFrame: 72 hours after treatment
measure: Change in Sequential Organ Failure Assessment (SOFA) Score in 72 Hours After Treatment
timeFrame: 72 hours after treatment
Other outcomes:
Locations:
city: Pathum Wan
country: Thailand
facility: Emergency Medicine Unit, King Chulalongkorn Memorial Hospital
state: Bangkok
Study officials:
affiliation: Emergency Unit, Faculty of Medicine, Chulalongkorn Hospital
name: Khrongwong Musikatavorn, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Musikatavorn K, Plitawanon P, Lumlertgul S, Narajeenron K, Rojanasarntikul D, Tarapan T, Saoraya J. Randomized Controlled Trial of Ultrasound-guided Fluid Resuscitation of Sepsis-Induced Hypoperfusion and Septic Shock. West J Emerg Med. 2021 Feb 10;22(2):369-378. doi: 10.5811/westjem.2020.11.48571.