HypovolemiaNCT04298931
Prediction of the Effect of Fluid Administration Using Arterial Pressure and Ventilator Data During Abdominal Surgery
An observational study of Hypovolemia and Fluid Overload, run by University of Aarhus at 1 site in Denmark.
Trial summary
It is well known, that patients with circulatory impairment sometimes, but not always, benefit from intravenous fluids. Predicting if a fluid administration will improve circulation is therefore of substantial clinical interest. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypovolemia, Fluid Overload
- What is being tested?
- Series of ventilator settings
- How many people
- 52 participants
- Where
- 1 siteDenmark
- Study dates
- 15 May 2020to 29 Jun 2021
- 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 at department of abdominal surgery, Aarhus University Hospital, scheduled for open abdominal surgery with planned use of Aarhus University Hospital's goal-directed therapy protocol (hemodynamic monitoring).
Who may be able to join
- Scheduled open abdominal surgery.
- Scheduled treatment with Aarhus University Hospital's goal-directed therapy protocol (hemodynamic monitoring).
Who cannot join
- Left ventricular ejection fraction ≤ 40 %
- Irregular heart rhythm (e.g. atrial fibrillation or frequent ectopic beats)
- Known right ventricular dysfunction (if reported qualitatively in pre-operative assessment or objectively via Tricuspid Annular Plane Systolic Excursion (TAPSE) < 17 mm)
- Pregnancy
- Prior participation in this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fluid Responsiveness Prediction Using Pulse Pressure Variation - Integrating Ventilator Settings
It is well known, that patients with circulatory impairment sometimes, but not always, benefit from intravenous fluids. Predicting if a fluid administration will improve circulation is therefore of substantial clinical interest.
Ventilator treatment induces cyclic variation in blood pressure due to interaction between the lungs and the heart. This variation is minor, but its amplitude may be used for guiding fluid administration.
Read more
However, this method of using ventilator-induced variation in blood pressure to predict the effect of fluid administration was developed when different settings for ventilator treatment was recommended, compared with today. With today's recommend ventilator treatment, the method is, unfortunately, less reliable.
The investigators will investigate how different ventilator settings influence variation in blood pressure, and the investigators will test if this knowledge allows us to better predict the effect of a fluid administration, by taking the ventilator settings into account.
- Conditions
- Hypovolemia, Fluid Overload
- Being tested
- Series of ventilator settings
- Medical subject headings
- Hypovolemia, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Series of ventilator settingsOther
Before a planned fluid administration, the investigators will apply a series of 10 ventilator settings for 30 seconds each.
The settings are the following combinations of respiratory rate (RR) and tidal volume (TV):
RR (min^-1), TV (ml/kg predicted body weight)
31, 6
31, 8
24, 6
24, 8
17, 6
17, 8
10, 4
10, 6
10, 8
10, 10
(the order of the respiratory rates: 17 to 31, will be randomized. 10/min will always be last. Tidal volume is always applied from lowest to highest for each respiratory rate).
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing open abdominal surgery | Not described Receives: Other: Series of ventilator settings |
What is being measured
The primary outcome is the main question the study is designed to answer.
>10% Increase in stroke volume from before to after a fluid bolus. (Fluid responsiveness)
A patient is considered a fluid responder if they have a >10% increase in stroke volume (pulse contour analysis by the Edwards EV1000 with a FloTrac sensor).
Pre-fluid stroke volume is calculated as the median stroke volume estimate in the two minutes immediately preceding the fluid bolus.
Post-fluid stroke volume is calculated as the median stroke volume estimate in the two minutes immediately following the fluid bolus.
Change in stroke volume is calculated as: 100% * (Post-fluid stroke volume - Pre-fluid stroke volume) / Pre-fluid stroke volume
Measured: From two minutes before to two minutes after a fluid administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2020
- Study start15 May 2020
- Primary completion29 Jun 2021
- Study completion29 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypovolemiaStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04298931
- Sponsor's protocol ID
- 1-10-72-245-19
- Status last verified
- Apr 2021
- First submitted
- 2 Mar 2020
- Last updated
- 16 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Enevoldsen J, Brandsborg B, Juhl-Olsen P, Rees SE, Thaysen HV, Scheeren TWL, Vistisen ST. The effects of respiratory rate and tidal volume on pulse pressure variation in healthy lungs-a generalized additive model approach may help overcome limitations. J Clin Monit Comput. 2024 Feb;38(1):57-67. doi: 10.1007/s10877-023-01090-6. Epub 2023 Nov 16.
PubMed 37968547
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluid Responsiveness Prediction Using Pulse Pressure Variation - Integrating Ventilator Settings
- ClinicalTrials.gov ID
- NCT04298931
- Acronym / sponsor ID
- 1-10-72-245-19
- Conditions
- Hypovolemia, Fluid Overload
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- 15 May 2020 (actual)
- Primary completion
- 29 Jun 2021 (actual)
- Study completion
- 29 Jun 2021 (actual)
- First posted
- 6 Mar 2020 (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.
It is well known, that patients with circulatory impairment sometimes, but not always, benefit from intravenous fluids. Predicting if a fluid administration will improve circulation is therefore of substantial clinical interest.
Ventilator treatment induces cyclic variation in blood pressure due to interaction between the lungs and the heart. This variation is minor, but its amplitude may be used for guiding fluid administration.
However, this method of using ventilator-induced variation in blood pressure to predict the effect of fluid administration was developed when different settings for ventilator treatment was recommended, compared with today. With today's recommend ventilator treatment, the method is, unfortunately, less reliable.
The investigators will investigate how different ventilator settings influence variation in blood pressure, and the investigators will test if this knowledge allows us to better predict the effect of a fluid administration, by taking the ventilator settings into account.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing open abdominal surgery | – | Other: Series of ventilator settings |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients at department of abdominal surgery, Aarhus University Hospital, scheduled for open abdominal surgery with planned use of Aarhus University Hospital's goal-directed therapy protocol (hemodynamic monitoring).
Key inclusion criteria (2 listed)
- Scheduled open abdominal surgery.
- Scheduled treatment with Aarhus University Hospital's goal-directed therapy protocol (hemodynamic monitoring).
Key exclusion criteria (5 listed)
- Left ventricular ejection fraction ≤ 40 %
- Irregular heart rhythm (e.g. atrial fibrillation or frequent ectopic beats)
- Known right ventricular dysfunction (if reported qualitatively in pre-operative assessment or objectively via Tricuspid Annular Plane Systolic Excursion (TAPSE) < 17 mm)
- Pregnancy
- Prior participation in this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Series of ventilator settingsBefore a planned fluid administration, the investigators will apply a series of 10 ventilator settings for 30 seconds each. The settings are the following combinations of respiratory rate (RR) and tidal volume (TV): RR (min^-1), TV (ml/kg predicted body weight) 31, 6 31, 8 24, 6 24, 8 17, 6 17, 8 10, 4 10, 6 10, 8 10, 10 (the order of the respiratory rates: 17 to 31, will be randomized. 10/min will always be last. Tidal volume is always applied from lowest to highest for each respiratory rate). | Other | Patients undergoing open abdominal surgery |
Primary outcome
>10% Increase in stroke volume from before to after a fluid bolus. (Fluid responsiveness)
Time frame: From two minutes before to two minutes after a fluid administration.
A patient is considered a fluid responder if they have a >10% increase in stroke volume (pulse contour analysis by the Edwards EV1000 with a FloTrac sensor). Pre-fluid stroke volume is calculated as the median stroke volume estimate in the two minutes immediately preceding the fluid bolus. Post-fluid stroke volume is calculated as the median stroke volume estimate in the two minutes immediately following the fluid bolus. Change in stroke volume is calculated as: 100% * (Post-fluid stroke volume - Pre-fluid stroke volume) / Pre-fluid stroke volume
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 16 Jul 2021.
- Derived from this study: PubMed 37968547Enevoldsen J, Brandsborg B, Juhl-Olsen P, Rees SE, Thaysen HV, Scheeren TWL, Vistisen ST. The effects of respiratory rate and tidal volume on pulse pressure variation in healthy lungs-a generalized additive model approach may help overcome limitations. J Clin Monit Comput. 2024 Feb;38(1):57-67. doi: 10.1007/s10877-023-01090-6. Epub 2023 Nov 16.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Hypovolemia and Fluid Overload, run by University of Aarhus at 1 site in Denmark.
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 16 Jul 2021. 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 Denmark. 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?
>10% Increase in stroke volume from before to after a fluid bolus. (Fluid responsiveness) (time frame: From two minutes before to two minutes after a fluid administration.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04298931, which also lists 1 linked publication.
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 16 Jul 2021.