NCT03204292

Brief Summary

ratio of the diameter of inferior vena cava to the diameter of the thoracic aorta (IVC / Ao) depends on the daily balance of fluids.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 24, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 2, 2017

Completed
Last Updated

July 2, 2017

Status Verified

June 1, 2017

Enrollment Period

1.5 years

First QC Date

June 24, 2017

Last Update Submit

June 28, 2017

Conditions

Keywords

Inferior vena cavaFluid responsivenessCentral venous pressure

Outcome Measures

Primary Outcomes (1)

  • fluid balance

    the width of the vena cava and abdominal aorta was measured every day morning. The difference in in taken and excreted fluids

    1 day

Study Arms (1)

IVC/Ao

ultrasound, the inferior vena cava and abdominal aorta were measured. Inferior vena cava width was assessed at an interval of approximately 1 cm distal from connection of the hepatic vein to the inferior vena cava. No significant changes were observed in the width of the inferior vena cava during various respiratory phases, because of the positive pressure ventilation. The widest value was always chosen for the data. The assessment of the width of the abdominal aorta was performed above arise of the celiac trunk, at the height of the vein of the lower vena cava.

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

There were 57 mechanically ventilated patients examined. 8 patients were excluded from the study because of spontaneous ventilation within 5 days of data collection. Two patients died during the study. Five patients failed to obtain satisfactory results of imaging of vascular structures during subsequent examination. Data from 42 patients were analyzed.

You may qualify if:

  • patients who were hospitalized in the Intensive Care Unit
  • severe respiratory failure requiring mechanical ventilation

You may not qualify if:

  • spontaneous breathing,
  • severe vascular disease,
  • increased intra-abdominal pressure,
  • cardiac pacemaker
  • cardioverter defibrillator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Krakow, Lesser Poland Voivodeship, 31-501, Poland

Location

MeSH Terms

Conditions

Edema

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Tomasz Skladzien, Ph.D.

    Jagiellonian University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
senior assistant

Study Record Dates

First Submitted

June 24, 2017

First Posted

July 2, 2017

Study Start

July 1, 2015

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

July 2, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

The assessment of the width of the abdominal aorta was performed above arise of the celiac trunk, at the height of the vein of the lower vena cava. The width of the inferior vena cava and the abdominal aorta was assessed using transthoracic ultrasound for the following five days. Daily differences in the amount of fluid intake and lost was recorded. CVP measurement was performed.

Locations