UMIN-CTR Clinical Trial

Public title

cardiac variation of internal jugular vein sonography for fluid responsiveness evaluation

Acronym

cardiac variation of internal jugular vein sonography for fluid responsiveness evaluation

Scientific Title

cardiac variation of internal jugular vein sonography for fluid responsiveness evaluation

Scientific Title:Acronym

cardiac variation of internal jugular vein sonography for fluid responsiveness evaluation

Region

Japan

Condition

dehydration

Classification by specialty

Medicine in general

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

We will examine whether the cardiac variation of internal jugular vein of patients in emergency department can be used as an predictor of intravascular volume status, fluid responsiveness, and analyze its physiological significance.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II,III

Primary outcomes

correlation between cardiac variation of internal jugular vein and fluid responsiveness. Fluid responsiveness is evaluated by whether the stroke volume increases by 15% or more after administration of 500-1000 mL of extracellular fluid.

Key secondary outcomes

comparison of accuracy between cardiac variation of internal jugular vein and respiratory variation of inferior vena cava and stroke volume variation.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Patients entered a specific emergency room who are judged by the emergency physician as needing hydration.

Key exclusion criteria

Severe patients who should give priority to medical treatment

Patients who cannot be supine position

Patients who cannot undergo ultrasonography due to neck injury etc.

Patients with organic abnormalities in superior vena cava to right internal jugular vein due to cervical mass, a
pical mass, etc.

Patients whose rapid administration of 500mL of extracellular fluid is medically harmful

Other patients who are determined to be inappropriate as subjects by the principal investigator

Target sample size

200

Name of lead principal investigator

1st name	Hidehiko
Middle name
Last name	Nakano

Organization

Hitachi General Hospital

Division name

Department of Emergency and Critical Care Medicine

Zip code

317-0077

Address

2-1-1, Jonantyo, Hitachi, Ibaraki, 317-0077, Japan.

TEL

0294-23-1111

Email

be.rann1988jp@gmail.com

Name of contact person

1st name	Hidehiko
Middle name
Last name	Nakano

Organization

Hitachi General Hospital

Division name

Department of Emergency and Critical Care Medicine

Zip code

317-0077

Address

2-1-1, Jonantyo, Hitachi, Ibaraki, 317-0077, Japan.

TEL

0294-23-1111

Homepage URL

Email

be.rann1988jp@gmail.com

Institute

Hitachi General Hospital

Institute

Department

Personal name

Organization

Japan Society for the Promotion of Science

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Hitachi General Hospital

Address

2-1-1, Jonantyo, Hitachi, Ibaraki, 317-0077, Japan.

Tel

0294-23-1111

Email

be.rann1988jp@gmail.com

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2019

Year

08

Month

15

Day

URL releasing protocol

https://www.sciencedirect.com/science/article/pii/S0301562922000722?via%3Dihub

Publication of results

Published

URL related to results and publications

https://www.sciencedirect.com/science/article/pii/S0301562922000722?via%3Dihub

Number of participants that the trial has enrolled

148

Results

Among the 148 patients enrolled, 105 were included in the final analysis. Fluid responsiveness did not correlate with the cardiac collapse index (13.6% vs. 16.8%, p = 0.24), but correlated with stroke volume variations (12.5% vs. 15.6%, p = 0.026). Although it is a simple correction, the cardiac collapse index correlated with stroke volume corrected by age (r = 0.25, p = 0.01), body surface area (r = 0.33, p = 0.002) and both (r = 0.35, p = 0.001).

Results date posted

2022

Year

08

Month

18

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Mean age was 74.3 y, 57 patients (54.3%) were male, mean height was 158.3 cm and mean weight was 54.8 kg. Diagnoses included dehydration in 46 patients (43.8%), sepsis in 44 (41.9%), syncope in 8 (7.6%) and anaphylaxis in 2 (1.9%). No significant differences were observed between the non-responder and responder groups.

Participant flow

Among 5625 patients who visited and were initially treated by the emergency department during the study period, 148 were enrolled. Of these, 105 patients were included in the final analysis after exclusion of 13 patients without stored ultrasound imaging data and 30 patients for whom measurements with the ClearSight System were not possible.

Adverse events

No adverse events occured.

Outcome measures

No significant differences were observed in systolic blood pressure (133.0 mm Hg vs. 135.2 mm Hg, p = 0.747) or heart rate (94.7 bpm vs. 95.3 bpm, p = 0.891) before the infusion or in systolic blood pressure (135.2 mm Hg vs. 136.9 mm Hg, p = 0.760) or heart rate (85.0 bpm vs. 85.6 bpm, p = 0.877) after the infusion. Similarly, diastolic blood pressure, mean arterial pressure, pulse pressure, shock index and modified shock index did not significantly differ before or after infusion therapy. SV was smaller (85.7 mL vs. 106.4 mL, p = 0.002) and SVV was larger (15.6 vs. 12.5%, p = 0.026) in the responder group. No significant differences were noted in the IJV cardiac collapse index (13.6% vs. 16.8%, p = 0.24) or IVC respiratory collapse index (45.6% vs. 41.8%, p = 0.535).

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2019

Year

05

Month

07

Day

Date of IRB

2019

Year

05

Month

07

Day

Anticipated trial start date

2019

Year

08

Month

15

Day

Last follow-up date

2020

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Measurement items are
Cardiac variation of internal jugular vein cross-sectional area , Blood pressure, Heart rate and cardiac output , stroke volume and stroke volume variation using clear sight before infusion.

Blood pressure, Heart rate and Cardiac output, Stroke volume and Stroke volume variation using clear site after infusion.

Registered date

2019

Year

08

Month

15

Day

Last modified on

2022

Year

08

Month

18

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042987