Cardiac SurgeryNCT03397784
IVC Variation After VT Challenge to Predict Fluid Responsiveness
An observational study of Cardiac Surgery and Fluid Challenge, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
The purpose of the study was to evaluate the efficacy of using the respiratory variation in inferior vena cava diameters as an index of fluid responsiveness after tidal volume challenge in mechanically ventilated patients after cardiac surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgery, Fluid Challenge, Fluid Responsiveness
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 3 Feb 2018to 31 Dec 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients after cardiac surgery
Who may be able to join
- acute circulatory failure (low blood pressure or urine output, tachycardia, or mottling)
- clinical signs of organ hypoperfusion (renal dysfunction or hyperlactatemia)
Who cannot join
- a contraindication to elevation of tidal volume
- evidence of cardiac arrhythmia
- left ventricular ejection fraction less than 50%
- echocardiographic examination that showed the existence of severe tricuspid or mitral regurgitation or right heart dysfunction
- intracardiac shunt
- pulmonary hypertension
Show all 13Show fewer
- severe chronic obstructive pulmonary disease
- a contraindication to the passive leg raising (PLR) test
- air leakage through chest drains
- abdominal compartment syndrome
- portal hypertension
- pregnancy
- inability to perform ultrasonography
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital, Fudan University
Shanghai, 200032
Luo Zhe, PhD, +86-21-64041990 ext. 3659
About this study
Official title: Can Respiratory Variation in Inferior Vena Cava Diameter After Tidal Volume Challenge Predict Fluid Responsiveness in Cardiac Surgical Patients With Mechanical Ventilation
The purpose of the study was to evaluate the efficacy of using the respiratory variation in inferior vena cava diameters as an index of fluid responsiveness after tidal volume challenge in mechanically ventilated patients after cardiac surgery.
Read the detailed description
The "tidal volume challenge" is a novel test to predict fluid responsiveness in patents in shock, ventilated using low tidal volume without spontaneous breathing activity. The test involves transiently increasing tidal volume from 8 ml/kg PBW to 12 ml/kg PBW for one minute and observing the change in PPV or SVV. The aim of this study was to evaluate whether the respiratory variation in inferior vena cava diameter after tidal volume challenge can predict fluid responsiveness in cardiac surgical patients with mechanical ventilation
- Keywords
- Tidal volume challenge, Fluid responsiveness, Preload responsiveness, Functional hemodynamic monitoring, Cardiac surgery, inferior vena cava variation
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 |
|---|---|---|
| fluid responders | Patients whose stroke volume index increase by ≥15% in response to a 500-ml fluid bolus was defined as fluid responders. | |
| fluid non-responders | Patients whose stroke volume index increase by <15% in response to a 500-ml fluid bolus was defined as fluid non-responders. |
What is being measured
The primary outcome is the main question the study is designed to answer.
fluid responsiveness
Patients will be classified as "fluid responders" if there is an increase in SV ≥15% after the fluid challenge, and the remaining patients are classified as "fluid non-responders"
Measured: after fluid challenge (30min)
Secondary outcomes (1)
inferior vena cava variation
Ultrasound equipment with convex probe will be used to measure IVC diameters of the patients in supine position.The IVC sagittal section is described with the probe in the area of subxiphoid. IVC diameters at the junction point of the IVC and right atrium (2cm caudal) are standardized measurement. The maximum anterior-posterior dimension came out from end-inspiration (IVCi, mm), whereas the minimum IVC diameter was shown in end-expiration (IVCe, mm). The IVC variation (IVCV) is calculated using the formula: IVCV (%) = (IVCi - IVCe) / [(IVCi+ IVCe) / 2] ×100%.
Measured: After tidal volume challenge (1 minute) and fluid challenge (30 minute)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2018
- Study start3 Feb 2018 (estimated)
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac SurgeryStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tu Guo-wei, PhD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03397784
- Sponsor's protocol ID
- VIVC-TVC
- Status last verified
- Jan 2018
- First submitted
- 1 Jan 2018
- Last updated
- 5 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Respiratory Variation in Inferior Vena Cava Diameter After Tidal Volume Challenge Predict Fluid Responsiveness in Cardiac Surgical Patients With Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT03397784
- Acronym / sponsor ID
- VIVC-TVC
- Keywords
- Tidal volume challenge, Fluid responsiveness, Preload responsiveness, Functional hemodynamic monitoring, Cardiac surgery, inferior vena cava variation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 3 Feb 2018 (estimated)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 12 Jan 2018 (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.
The purpose of the study was to evaluate the efficacy of using the respiratory variation in inferior vena cava diameters as an index of fluid responsiveness after tidal volume challenge in mechanically ventilated patients after cardiac surgery.
Detailed description
The "tidal volume challenge" is a novel test to predict fluid responsiveness in patents in shock, ventilated using low tidal volume without spontaneous breathing activity. The test involves transiently increasing tidal volume from 8 ml/kg PBW to 12 ml/kg PBW for one minute and observing the change in PPV or SVV. The aim of this study was to evaluate whether the respiratory variation in inferior vena cava diameter after tidal volume challenge can predict fluid responsiveness in cardiac surgical patients with mechanical ventilation
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fluid responders | – | –Patients whose stroke volume index increase by ≥15% in response to a 500-ml fluid bolus was defined as fluid responders. |
| fluid non-responders | – | –Patients whose stroke volume index increase by <15% in response to a 500-ml fluid bolus was defined as fluid non-responders. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients after cardiac surgery
Key inclusion criteria (2 listed)
- acute circulatory failure (low blood pressure or urine output, tachycardia, or mottling)
- clinical signs of organ hypoperfusion (renal dysfunction or hyperlactatemia)
Key exclusion criteria (13 listed)
- a contraindication to elevation of tidal volume
- evidence of cardiac arrhythmia
- left ventricular ejection fraction less than 50%
- echocardiographic examination that showed the existence of severe tricuspid or mitral regurgitation or right heart dysfunction
- intracardiac shunt
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 responsiveness
Time frame: after fluid challenge (30min)
Patients will be classified as "fluid responders" if there is an increase in SV ≥15% after the fluid challenge, and the remaining patients are classified as "fluid non-responders"
1 secondary outcome
inferior vena cava variation
Time frame: After tidal volume challenge (1 minute) and fluid challenge (30 minute)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2018.
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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.
Tu Guo-wei, PhD principal investigator
Fudan 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 Cardiac Surgery and Fluid Challenge, run by Shanghai Zhongshan Hospital at 1 site in China.
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 13 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: status not confirmed, as of the sponsor's last update on 5 Feb 2018. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luo Zhe, PhD (021-64041990 ext. 3659, luo.zhe@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fluid responsiveness (time frame: after fluid challenge (30min)). 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 5 Feb 2018.