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CompletedNCT03349593Updated Jan 5, 2022

Prevalence of Hypovolemia and Heart Failure in Non-cardiac Surgery

An observational study in Hypovolemia, Heart Failure and Diastolic Dysfunction, sponsored by Umeå University. Completed at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-01-05.

Sponsored by Umeå University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Hypovolemia
  • Heart Failure
  • Diastolic Dysfunction
  • Systolic Dysfunction
  • Venous; Return (Anomaly)

Keywords

  • Heart failure, diastolic dysfunction, venous return
  • Left ventricular filling pressures
03

In context

Hypovolemia

122 studies on the registry are indexed under Hypovolemia; 14 are open to participants now.

This study's enrollment of 100 is above the median of 51 across 58 observational studies indexed under Hypovolemia.

Browse Hypovolemia studies →

Lead sponsor

Umeå University is the lead sponsor of 272 studies on the registry; 60 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Electively scheduled individuals for breast cancer surgery, endocrinologic surgery (thyroid, parathyroid) and general abdominal surgery.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • ≤ 35 kg/m2, electively scheduled for breast cancer surgery, endocrinologic surgery (thyroid, parathyroid) and general abdominal surgery.

Exclusion criteria

Exclusion Criteria:

  • Not signed consent.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (actual)
Patient registry
No

Interventions

  • Diagnostic testEchocardiography

    Preoperative transthoracic echocardiography

06

What researchers measure

Primary outcomes

  1. Hypovolemia

    Screening of preoperative level of venous return

    Time frame: One hour before surgery

  2. Heart failure

    Screening of incidence of preoperative systolic and diastolic function

    Time frame: One hour before surgery

07

Study locations

1 site
  • Sunderby hospital
    Luleå, 97180, Sweden
08

References and documents

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 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Dec 2017 to primary completion in Nov 2018, 11 months.

Of 25 observational studies under Hypovolemia, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 30. This study's 11 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 17, 2017
First posted
Nov 21, 2017
StartActual
Dec 1, 2017
Primary completionActual
Nov 30, 2018
CompletionActual
Dec 30, 2019
Last update
Jan 5, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 5, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03349593
Lead sponsor
Umeå University
Responsible party
Tomi Myrberg (Principal investigator, Umeå University) — Principal investigator
First posted
Nov 21, 2017
Start date
Dec 1, 2017
Primary completion
Nov 30, 2018
Completion
Dec 30, 2019
Last update
Jan 5, 2022

Study contacts

Tomi P Myrberg, MD PhD
principal investigator · Umeå University, Norrbotten county concil

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

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Discussion

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