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

Septic Shock Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03020407
• Other study ID #: 589/59
• Status: Completed
• Phase: N/A
• Start date: January 18, 2017
• Est. completion date: July 31, 2020

Study information

• Verified date: April 2021
• Source: Chulalongkorn University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 211
• Est. completion date: July 31, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Septic Shock
• Shock
• Shock, Septic

Intervention

Procedure:
• IVC Ultrasound-guided
IVC is identified in longitudinal section in the subcostal area of a patient using the curvilinear probe of standard ultrasound. The selected area of IVC diameter measurement is set at 2 centimeters distal to the confluence of hepatic vein by M-mode coupled by two-dimensional mode on frozen screen images using the Sonosite® X-porte.

Drug:
• Antibiotics
Prompt empirical antibiotics will be given to the patients within one hour before the treatment allocation.
• Vasopressor
The threshold to the need of a vasopressor is set at mean arterial pressure below 65 mmHg if a patient's condition does not response to the fluid therapy.

Locations

Country	Name	City	State
Thailand	Emergency Medicine Unit, King Chulalongkorn Memorial Hospital	Pathum Wan	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	30-day Mortality	30-day mortality related to septic shock	30 day after randomization
Secondary	Percentage Change of 6-hour Lactate	The percentage change in blood lactate at 6 hour after initiation of treatment, calculated by [(Initial blood lactate level at presentation - blood lactate level at 6 hours after treatment)/Initial blood lactate level at presentation] x 100%. The higher positive value means the more relative reduction of blood lactate after treatment from that of initial presentation and indicates a better clinical outcome.	6 hours after treatment
Secondary	6-hour Cumulative Amount of Intravenous Fluid (mL)	Cumulative amount of intravenous fluid (mL) during the first 6 hours after treatment.	6 hours after treatment
Secondary	72-hour Cumulative Amount of Intravenous Fluid (mL) After Treatment	Cumulative amount of intravenous fluid (mL) during the first 72 hours after treatment.	72 hours after treatment
Secondary	Change in Sequential Organ Failure Assessment (SOFA) Score in 72 Hours After Treatment	The change in Sequential Organ Failure Assessment (SOFA) score between the score at initial presentation and 72 hours after treatment, determined by SOFA score at presentation minus the SOFA score at 72 hours after treatment. The possible minimum and maximum value of the change in SOFA score are -24 and +24, respectively. The higher value means the more relative reduction in SOFA score at 72 hours and indicates a better clinical outcome.	72 hours after treatment