HypovolemiaNCT03349593
Prevalence of Hypovolemia and Heart Failure in Non-cardiac Surgery
An observational study of Hypovolemia and Heart Failure, run by Umeå University at 1 site in Sweden.
Trial summary
Prevalence of biventricular function of the heart and preoperative level of venous return is not known in non-cardiac non-morbid obese population. The aim of the study is to assess the preoperative function of the heart and status of hypovolemia on the day of surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypovolemia, Heart Failure, Diastolic Dysfunction
- What is being tested?
- Echocardiography
- How many people
- 100 participants
- Where
- 1 siteSweden
- Study dates
- 1 Dec 2017to 30 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: Electively scheduled individuals for breast cancer surgery, endocrinologic surgery (thyroid, parathyroid) and general abdominal surgery.
Who may be able to join
- body mass index ≤ 35 kg/m2, electively scheduled for breast cancer surgery, endocrinologic surgery (thyroid, parathyroid) and general abdominal surgery.
Who cannot join
- Not signed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Prevalence of biventricular function of the heart and preoperative level of venous return is not known in non-cardiac non-morbid obese population.
The aim of the study is to assess the preoperative function of the heart and status of hypovolemia on the day of surgery.
Read the detailed description
Preoperative transthoracic echocardiography (TTE) is conducted in 100 individuals. Biventricular function (i.e. systolic and diastolic properties), left ventricular filling pressures and level of venous return are assessed by TTE.
Moreover high-sensitive troponine I and Nt-proBNP, ECG are collected. Multiple echocardiographic parameters will be studied for feasibility in terms of preoperative assessment of the heart.
- Conditions
- Hypovolemia, Heart Failure, Diastolic Dysfunction, Systolic Dysfunction, Venous; Return (Anomaly)
- Being tested
- Echocardiography
- Keywords
- Heart failure, diastolic dysfunction, venous return, Left ventricular filling pressures
- Medical subject headings
- Hypovolemia, Heart Failure, Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchocardiographyDiagnostic test
Preoperative transthoracic echocardiography
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypovolemia
Screening of preoperative level of venous return
Measured: One hour before surgery
Heart failure
Screening of incidence of preoperative systolic and diastolic function
Measured: One hour before surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2017
- Study start1 Dec 2017
- Primary completion30 Nov 2018
- Study completion30 Dec 2019
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 Umeå UniversityThe 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tomi Myrberg, Umeå University
- Investigators
- Tomi P Myrberg, MD PhD, Principal investigator, Umeå University, Norrbotten county concil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03349593
- Sponsor's protocol ID
- 2016/361-31 II
- Status last verified
- Dec 2021
- First submitted
- 17 Nov 2017
- Last updated
- 5 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Stenberg Y, Rhodin Y, Lindberg A, Aroch R, Hultin M, Wallden J, Myrberg T. Pre-operative point-of-care assessment of left ventricular diastolic dysfunction, an observational study. BMC Anesthesiol. 2022 Apr 5;22(1):96. doi: 10.1186/s12871-022-01642-4.
PubMed 35382761
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Hypovolemia and Heart Failure in Non-cardiac Surgery
- ClinicalTrials.gov ID
- NCT03349593
- Acronym / sponsor ID
- 2016/361-31 II
- Conditions
- Hypovolemia, Heart Failure, Diastolic Dysfunction, Systolic Dysfunction, Venous; Return (Anomaly)
- Keywords
- Heart failure, diastolic dysfunction, venous return, Left ventricular filling pressures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 21 Nov 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.
Prevalence of biventricular function of the heart and preoperative level of venous return is not known in non-cardiac non-morbid obese population.
The aim of the study is to assess the preoperative function of the heart and status of hypovolemia on the day of surgery.
Detailed description
Preoperative transthoracic echocardiography (TTE) is conducted in 100 individuals. Biventricular function (i.e. systolic and diastolic properties), left ventricular filling pressures and level of venous return are assessed by TTE.
Moreover high-sensitive troponine I and Nt-proBNP, ECG are collected. Multiple echocardiographic parameters will be studied for feasibility in terms of preoperative assessment of the heart.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Electively scheduled individuals for breast cancer surgery, endocrinologic surgery (thyroid, parathyroid) and general abdominal surgery.
Key inclusion criteria (1 listed)
- body mass index ≤ 35 kg/m2, electively scheduled for breast cancer surgery, endocrinologic surgery (thyroid, parathyroid) and general abdominal surgery.
Key exclusion criteria (1 listed)
- Not signed 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 |
|---|---|---|
| EchocardiographyPreoperative transthoracic echocardiography | Diagnostic test | – |
Primary outcome
Hypovolemia
Time frame: One hour before surgery
Screening of preoperative level of venous return
Heart failure
Time frame: One hour before surgery
Screening of incidence of preoperative systolic and diastolic function
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 5 Jan 2022.
- Derived from this study: PubMed 35382761Stenberg Y, Rhodin Y, Lindberg A, Aroch R, Hultin M, Wallden J, Myrberg T. Pre-operative point-of-care assessment of left ventricular diastolic dysfunction, an observational study. BMC Anesthesiol. 2022 Apr 5;22(1):96. doi: 10.1186/s12871-022-01642-4.
- 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.
Tomi P Myrberg, MD PhD principal investigator
Umeå University, Norrbotten county concil
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 Heart Failure, run by Umeå University at 1 site in Sweden.
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 1 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 5 Jan 2022. 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 Sweden. 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?
Hypovolemia (time frame: One hour before surgery). 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 NCT03349593, 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 5 Jan 2022.