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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT03020407
• Date of registration: 03/01/2017
• Prospective Registration: Yes
• Primary sponsor: Chulalongkorn University
• Public title: The Randomized Controlled Trial of Inferior Vena Cava Ultrasound-guided Fluid Management in Septic Shock Resuscitation
• Scientific title: The Randomized Controlled Trial of Inferior Vena Cava Ultrasound-guided Fluid Management in Septic Shock Resuscitation
• Date of first enrolment: January 18, 2017
• Target sample size: 254
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT03020407
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Thailand

Contacts

• Name: Khrongwong Musikatavorn, MD

• Name: Khrongwong Musikatavorn, MD
• Affiliation: Emergency Unit, Faculty of Medicine, Chulalongkorn Hospital

• Name: Khrongwong Musikatavorn, MD

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Septic Shock

Intervention(s)

Drug: Vasopressor

Procedure: IVC Ultrasound-guided

Drug: Antibiotics

Primary Outcome(s)

30-day mortality [Time Frame: 30 day after randomization]

Secondary Outcome(s)

6-hour cumulative amount of intravenous fluid [Time Frame: 6 hours after randomization]

Change in Sequential Organ Failure (SOFA) score in 72 hours [Time Frame: 72 hours after randomization]

72-hour cumulative amount of intravenous fluid [Time Frame: 72 hours after randomization]

6-hour lactate clearance [Time Frame: 6 hours after randomization]

Secondary ID(s)

589/59

Source(s) of Monetary Support

Please refer to primary and secondary sponsors