HypovolemiaNCT02903316
Predicting Fluid Responsiveness in on Pump Coronary Artery Bypass Graft Using Extra Systoles
An observational study of Hypovolemia and Coronary Artery Disease, run by University of Aarhus at 1 site in Denmark.
Trial summary
The purpose of this study is to determine if extra systoles can be used to predict fluid responsiveness perioperatively in patients undergoing on pump coronary artery bypass graft (CABG) surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypovolemia, Coronary Artery Disease, Fluid Overload
- What is being tested?
- Fluids
- Type of treatment
- Surgery or procedure
- How many people
- 95 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2016to Oct 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients scheduled for elective on pump CABG surgery at Aarhus University Hospital, SKS.
Who may be able to join
- Predominant sinus rhythm (No atrial fibrillation, trigemini, 2nd and 3rd degree atrioventricular block also if pacing is present etc.)
Who cannot join
- Ejection fraction < 35% (Safety limit minimising risk of fluid overload)
- Haemodialysis (safety precaution for patients with end-stage kidney failure)
- Pregnancy
- Mentally retarded (due to lack of capability to sign an informed consent)
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Anesthesia and Intensive Care Medicine, Cardiothoracic Anesthesia, Head & Heart Centre, Aarhus University Hospital
Aarhus N, 8200
About this study
Official title: Predicting Fluid Responsiveness in on Pump Coronary Artery Bypass Graft Using Extra Systoles and Investigation of a Novel Mini Fluid Challenge Ability to Predict Fluid Responsiveness
The purpose of this study is to determine if extra systoles can be used to predict fluid responsiveness perioperatively in patients undergoing on pump coronary artery bypass graft (CABG) surgery. As an additional study we will investigate the ability of a mini fluid challenge to predict response of a larger volume of fluid.
Read the detailed description
From induction of anaesthesia to cardioplegia we will serve two fluid challenges. Before and after each challenge we will collect hemodynamic data and use this to asses our two hypotheses.
Fluid responsiveness (the outcome to predict) will be defined as a 15% increase in stroke volume(SV) from immediately before fluid infusion is initiated (baseline) to after the full fluid infusion. Stroke volume is derived from the gold-standard pulmonary artery catheter measurement of cardiac output(CO), which is standard monitoring for these patients (SV = CO/heart rate). From subsequent offline analysis of the extracted curve data we will investigate if post-ectopic characteristics from identified extra systoles during the baseline period can predict fluid responsiveness (i.e. the SV change). This analysis addresses the primary hypothesis. Also, we will analyse the arterial waveform related to the mini fluid challenge for morphologic changes (comparing heart beats before the infusion with heart beats during the infusion) and see if such transient changes, e.g. in systolic blood pressure, are able to predict fluid responsiveness. This analysis addresses the secondary hypothesis.
- Conditions
- Hypovolemia, Coronary Artery Disease, Fluid Overload
- Being tested
- Fluids
- Keywords
- Fluid responsiveness, Perioperative, Extra systoles, Coronary artery bypass, Systolic arterial pressure
- Medical subject headings
- Hypovolemia, Coronary Artery Disease, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluidsProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Fluid Therapy | Systematisation of fluids during CABG surgery Receives: Procedure: Fluids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac output changes
From initiation of fluid infusion
Measured: At 5 minutes
Systolic arterial pressure changes
In relation to extra systoles
Measured: 10 minutes prior to fluid infusion
Secondary outcomes (1)
Arterial waveform changes
From initiation of the mini fluid challenge (part of the compiled fluid challenge)
Measured: 10 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2016 (estimated)
- Study startOct 2016
- Primary completionAug 2017
- Study completionOct 2017
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
- Case only
- Time perspective
- Prospective
- Enrolment
- 95 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
- NCT02903316
- Sponsor's protocol ID
- 53665
- Status last verified
- Sep 2016
- First submitted
- 5 Sep 2016
- Last updated
- 27 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: No consent for sharing personal data.
Publications
Berg JM, Nielsen DV, Abromaitiene V, Hjornet NE, Vistisen ST. Changes in arterial blood pressure characteristics following an extrasystolic beat or a fast 50 ml fluid challenge do not predict fluid responsiveness during cardiac surgery. J Clin Monit Comput. 2022 Jun;36(3):889-900. doi: 10.1007/s10877-021-00722-z. Epub 2021 May 26.
PubMed 34041648
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Fluid Responsiveness in on Pump Coronary Artery Bypass Graft Using Extra Systoles and Investigation of a Novel Mini Fluid Challenge Ability to Predict Fluid Responsiveness
- ClinicalTrials.gov ID
- NCT02903316
- Acronym / sponsor ID
- 53665
- Conditions
- Hypovolemia, Coronary Artery Disease, Fluid Overload
- Keywords
- Fluid responsiveness, Perioperative, Extra systoles, Coronary artery bypass, Systolic arterial pressure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- Oct 2016 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 16 Sep 2016 (estimated)
- 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 this study is to determine if extra systoles can be used to predict fluid responsiveness perioperatively in patients undergoing on pump coronary artery bypass graft (CABG) surgery. As an additional study we will investigate the ability of a mini fluid challenge to predict response of a larger volume of fluid.
Detailed description
From induction of anaesthesia to cardioplegia we will serve two fluid challenges. Before and after each challenge we will collect hemodynamic data and use this to asses our two hypotheses.
Fluid responsiveness (the outcome to predict) will be defined as a 15% increase in stroke volume(SV) from immediately before fluid infusion is initiated (baseline) to after the full fluid infusion. Stroke volume is derived from the gold-standard pulmonary artery catheter measurement of cardiac output(CO), which is standard monitoring for these patients (SV = CO/heart rate). From subsequent offline analysis of the extracted curve data we will investigate if post-ectopic characteristics from identified extra systoles during the baseline period can predict fluid responsiveness (i.e. the SV change). This analysis addresses the primary hypothesis. Also, we will analyse the arterial waveform related to the mini fluid challenge for morphologic changes (comparing heart beats before the infusion with heart beats during the infusion) and see if such transient changes, e.g. in systolic blood pressure, are able to predict fluid responsiveness. This analysis addresses the secondary hypothesis.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fluid Therapy | – | Procedure: FluidsSystematisation of fluids during CABG surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients scheduled for elective on pump CABG surgery at Aarhus University Hospital, SKS.
Key inclusion criteria (1 listed)
- Predominant sinus rhythm (No atrial fibrillation, trigemini, 2nd and 3rd degree atrioventricular block also if pacing is present etc.)
Key exclusion criteria (4 listed)
- Ejection fraction < 35% (Safety limit minimising risk of fluid overload)
- Haemodialysis (safety precaution for patients with end-stage kidney failure)
- Pregnancy
- Mentally retarded (due to lack of capability to sign an informed consent)
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 |
|---|---|---|
| Fluids | Procedure or surgery | Fluid Therapy |
Primary outcome
Cardiac output changes
Time frame: At 5 minutes
From initiation of fluid infusion
Systolic arterial pressure changes
Time frame: 10 minutes prior to fluid infusion
In relation to extra systoles
1 secondary outcome
Arterial waveform changes
Time frame: 10 seconds
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 27 Oct 2017.
- Derived from this study: PubMed 34041648Berg JM, Nielsen DV, Abromaitiene V, Hjornet NE, Vistisen ST. Changes in arterial blood pressure characteristics following an extrasystolic beat or a fast 50 ml fluid challenge do not predict fluid responsiveness during cardiac surgery. J Clin Monit Comput. 2022 Jun;36(3):889-900. doi: 10.1007/s10877-021-00722-z. Epub 2021 May 26.
- Individual participant dataSharing planned: No. No consent for sharing personal data.
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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 Coronary Artery Disease, 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 1 inclusion and 4 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 27 Oct 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 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?
Cardiac output changes (time frame: At 5 minutes). The study lists 2 primary outcomes in all. 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 NCT02903316, 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 27 Oct 2017.