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

NCT03020407 | Completed Results DMC

• 1 other identifier: 589/59
• Study Type: interventional
• Target: 211
• Locations: 1 country
• Sites: 1

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.

Conditions

Septic Shock

Keywords

Septic Shock; Inferior vene cava diameter; Resuscitation; Mortality

Outcome Measures

Primary Outcomes (1)

• 30-day Mortality

  30-day mortality related to septic shock

  30 day after randomization

Secondary Outcomes (4)

• Percentage Change of 6-hour Lactate

  6 hours after treatment

• 6-hour Cumulative Amount of Intravenous Fluid (mL)

  6 hours after treatment

• 72-hour Cumulative Amount of Intravenous Fluid (mL) After Treatment

  72 hours after treatment

• Change in Sequential Organ Failure Assessment (SOFA) Score in 72 Hours After Treatment

  72 hours after treatment

Study Arms (2)

IVC Ultrasound-guided

EXPERIMENTAL

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.

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

Usual care

NO INTERVENTION

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.

Interventions

IVC Ultrasound-guided PROCEDURE

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.

IVC Ultrasound-guided

Antibiotics DRUG

Prompt empirical antibiotics will be given to the patients within one hour before the treatment allocation.

Also known as: Antimicrobials

IVC Ultrasound-guided

Vasopressor DRUG

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.

Also known as: Norepinephrine, dopamine, epinephrine

IVC Ultrasound-guided

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.)

You may not qualify if:

• \) Congestive pulmonary edema or known to have poor systolic cardiac function (left ventricular ejection fraction ≤ 40%).
• \) Known to have right heart pathologies.
• \) Having or suspected to have marked ascites, significant bowel dilatation or the conditions that can cause abdominal hypertension.
• \) Body mass index ≥ 30 kg/square meter.
• \) Having concomitant attack of severe airway disease (eg. Asthma, COPD) that may have confounded the IVC interpretation due to the positive intrathoracic pressure.
• \) IVC can not be identified or its diameter cannot be measured correctly.
• \) Having end-stage renal diseases with or without dialysis.
• \) Having non-infectious diseases as final diagnoses.
• \) Pregnant women.
• \) Have been referred or treated from other healthcare facility.
• \) Having active hemorrhages.
• \) Duplicated cases.
• \) who had "do-not-resuscitate" living will.
• \) Declined to consent.

Sponsors & Collaborators

• Chulalongkorn University: lead

Study Sites (1)

Emergency Medicine Unit, King Chulalongkorn Memorial Hospital

Pathum Wan, Bangkok, 11130, Thailand

Location

Related 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.

  PMID: 33856325 BACKGROUND

MeSH Terms

Conditions

Shock, Septic

Interventions

Anti-Bacterial Agents; Anti-Infective Agents; Vasoconstrictor Agents; Norepinephrine; Dopamine; Epinephrine

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Cardiovascular Agents; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Limitations and Caveats

This study was conducted with the specific study protocol at a single, tertiary-care hospital. Second, physicians should use cautious clinical judgment or different approaches in different types of patients. The interpersonal variation and sampling position may have affected the consistency of IVC diameter measurement.

Results Point of Contact

• Title: Dr. Khrongwong Musikatavorn
• Organization: Department of Emergency Medicine, Faculty of Medicine, Chulalongkorn University

kmusikatavorn@yahoo.com

+6626494000

Study Officials

• Khrongwong Musikatavorn, MD

  Emergency Unit, Faculty of Medicine, Chulalongkorn Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2017
• First Posted: January 13, 2017
• Study Start: January 18, 2017
• Primary Completion: June 30, 2020
• Study Completion: July 31, 2020
• Last Updated: September 22, 2021
• Results First Posted: August 30, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)