N/A N=211 Randomized Single-blind Treatment

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

Septic Shock

Bottom Line

View on ClinicalTrials.gov: NCT03020407 ↗

Enrolled (actual)

211

Serious AEs

32.7%

Results posted

Aug 2021

Primary outcome: Primary: 30-day Mortality — 20; 19 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: IVC Ultrasound-guided (Procedure); Antibiotics (Drug); Vasopressor (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Chulalongkorn University
Primary completion: Jun 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY 30-day Mortality	20; 19	—
SECONDARY Percentage Change of 6-hour Lactate	39.2; 35.9	—
SECONDARY 6-hour Cumulative Amount of Intravenous Fluid (mL)	1900; 2600	—
SECONDARY 72-hour Cumulative Amount of Intravenous Fluid (mL) After Treatment	7,300; 7,702	—
SECONDARY Change in Sequential Organ Failure Assessment (SOFA) Score in 72 Hours After Treatment	1; 1	—

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.

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.

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Data sourced from ClinicalTrials.gov (NCT03020407). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.