ClinicalTrials.gg
Status unknownNCT04288466GEMAUpdated Feb 28, 2020

Gastric Emptying of Maltodextrin Solution in Elderly and in Adults

An interventional study of maltodextrin in Aspiration; Liquids, Fasting and Perioperative Pulmonary Aspiration, sponsored by Brasilia University Hospital. Status unknown at 1 site in Brazil. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-28.

Sponsored by Brasilia University Hospital · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Feb 2020), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

Gastric volume will be measured before, 5, 30, 60, 90 and 120 min after drinking 450ml of maltodextrin in young adults and elderly.

Read the detailed description

Gastric volume will be estimated before, 5, 30, 60, 90 and 120 min after drinking 450ml of maltodextrin in young adults and elderly using antral ultrasound.

02

Conditions studied

  • Aspiration; Liquids
  • Fasting
  • Perioperative Pulmonary Aspiration

Browse trials for

03

In context

Fasting

392 studies on the registry are indexed under Fasting; 63 are open to participants now.

This study's planned enrollment of 60 is above the median of 45 across 311 interventional studies indexed under Fasting.

Browse Fasting studies →

Lead sponsor

Brasilia University Hospital is the lead sponsor of 20 studies on the registry; none 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
Yes

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

  • I or II;
  • No known risk factor for slow or fast gastric emptying.

Exclusion criteria

Exclusion Criteria:

  • Vomiting the study solution before completion.
  • Wrong timing of assessment.
  • Protocol violation.
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.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    Adults

    Adults \< 60 years-old maltodextrin solution 450ml

    Dietary Supplement: maltodextrin

  • Active comparator
    Elders

    Elders 65 or more years-old maltodextrin solution 450ml

    Dietary Supplement: maltodextrin

Interventions

06

What researchers measure

Primary outcomes

  1. Antral Volume change

    Antral volume in cm² assessed by ultrasound in semirecumbent position.

    Time frame: Just before and 5, 30, 60, 90 and 120 minutes after drinking the study solution (repeated measures)

07

Study locations

1 site
  • Hospital das Forças armadas
    Brasilia, Distrito Federal 700000000, Brazil
08

References and documents

Individual participant data

Plan to share: Yes — Plan to Share in Online Data Sharing Platform.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Analytic code

Time frame: We will put SAP and Analytic code in RPubs for as long as RPubs exists. Study protocol and ICF will be published in ClinicalTrials

Access criteria: Open

No publications or documents are linked to this record.

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

Started Jan 2020 (actual). Primary completion is estimated for Apr 2020, 3 months after the start.

Of 144 non-industry interventional studies with no phase under Fasting, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 40. This study's planned 3 months is below that.

Counting every sponsor, half of 149 studies reached it within 18 months; a quarter within 6 and three quarters within 40.

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

Registered
Feb 26, 2020
First posted
Feb 28, 2020
StartActual
Jan 1, 2020
Primary completionEst.
Apr 1, 2020
CompletionEst.
Jul 1, 2020
Last update
Feb 28, 2020
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 Feb 28, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04288466
Lead sponsor
Brasilia University Hospital
Responsible party
Gabriel Magalhaes Nunes Guimaraes (Clinical Professor, Brasilia University Hospital) — Principal investigator
First posted
Feb 28, 2020
Start date
Jan 1, 2020
Primary completion
Apr 1, 2020 (estimated)
Completion
Jul 1, 2020 (estimated)
Last update
Feb 28, 2020

Study contacts

Gabriel MN Guimaraes, MSc
principal investigator · Professor

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 status unknown, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Maltodextrin

Start the discussion