Fluid OverloadNCT03204292
Evaluating the Fluid Balance of Mechanically Ventilated Patients by Ultrasonography
An observational study of Fluid Overload and Fluid Loss, run by Jagiellonian University at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Fluid Overload, Fluid Loss
- How many people
- 57 participants
- Where
- 1 sitePoland
- Study dates
- Jul 2015to Jan 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- patients who were hospitalized in the Intensive Care Unit
- severe respiratory failure requiring mechanical ventilation
Who cannot join
- spontaneous breathing,
- severe vascular disease,
- increased intra-abdominal pressure,
- cardiac pacemaker
- cardioverter defibrillator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Measurement of the Inferior Vena Cava as a Method of Evaluating the Fluid Balance of Mechanically Ventilated Patients
ratio of the diameter of inferior vena cava to the diameter of the thoracic aorta (IVC / Ao) depends on the daily balance of fluids.
Read the detailed description
During the routine abdominal ultrasound, the basilar and abdominal aorta were measured using a Sparq Philips ultrasonograph with a convex probe set in abdominal mode. All measurements were performed in one patient by the same operator who were experienced and performed the appropriate course of ultrasonography. The IVC and abdominal aorta were visualized using a paramedian long-axis view via a subcostal approach according to the methodology described by the American Society of Echocardiography. 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. 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.
- Conditions
- Fluid Overload, Fluid Loss
- Keywords
- Inferior vena cava, Fluid responsiveness, Central venous pressure
- Medical subject headings
- Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
fluid balance
the width of the vena cava and abdominal aorta was measured every day morning. The difference in in taken and excreted fluids
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study startJul 2015
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fluid OverloadStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jagiellonian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tomasz Skladzien, Jagiellonian University
- Investigators
- Tomasz Skladzien, Ph.D., Principal investigator, Jagiellonian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03204292
- Sponsor's protocol ID
- 122.6120.85.2015
- Status last verified
- Jun 2017
- First submitted
- 24 Jun 2017
- Last updated
- 2 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of the Inferior Vena Cava as a Method of Evaluating the Fluid Balance of Mechanically Ventilated Patients
- ClinicalTrials.gov ID
- NCT03204292
- Acronym / sponsor ID
- 122.6120.85.2015
- Conditions
- Fluid Overload, Fluid Loss
- Keywords
- Inferior vena cava, Fluid responsiveness, Central venous pressure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Jagiellonian UniversityUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 2 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
ratio of the diameter of inferior vena cava to the diameter of the thoracic aorta (IVC / Ao) depends on the daily balance of fluids.
Detailed description
During the routine abdominal ultrasound, the basilar and abdominal aorta were measured using a Sparq Philips ultrasonograph with a convex probe set in abdominal mode. All measurements were performed in one patient by the same operator who were experienced and performed the appropriate course of ultrasonography. The IVC and abdominal aorta were visualized using a paramedian long-axis view via a subcostal approach according to the methodology described by the American Society of Echocardiography. 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. 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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- patients who were hospitalized in the Intensive Care Unit
- severe respiratory failure requiring mechanical ventilation
Key exclusion criteria (5 listed)
- spontaneous breathing,
- severe vascular disease,
- increased intra-abdominal pressure,
- cardiac pacemaker
- cardioverter defibrillator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
fluid balance
Time frame: 1 day
the width of the vena cava and abdominal aorta was measured every day morning. The difference in in taken and excreted fluids
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Individual participant dataSharing planned: No. 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.
Related trials for Fluid Overload
Recruiting
Early Deresuscitation Strategy Driven by Tissue Perfusion in Renal Replacement Therapy in Patients With Acute Renal Failure
Acute Kidney Injury, Fluid Overload
Recruiting
Reducing Fluid Overload in Heart Failure Patients Using a Non-invasive, Renal Independent System
Chronic Heart Failure, CKD Stage 3
Not yet recruitingPhase 4
Capital Offload-Shock
Hypervolemia, Cardiogenic Shock
Recruiting
Dry Weight Reduction Intervention Via Extra Ultrafiltration
Fluid Accumulation, Blood Pressure Management
Not yet recruiting
Bioimpedance and Multiparametric Ultrasound-Guided Fluid Management After Kidney Transplantation
Kidney Transplantation, Delayed Graft Function
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tomasz Skladzien, Ph.D. principal investigator
Jagiellonian University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fluid Overload and Fluid Loss, run by Jagiellonian University at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fluid balance (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.