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CompletedNCT05238051Updated Feb 14, 2022

Gastric Residual Volume Measurement in the Intensive Care Unit

An interventional study of Gastric residual volume measurement stopped. in Preventing Malnutrition, sponsored by Erzincan Binali Yildirim Universitesi. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-02-14.

Sponsored by Erzincan Binali Yildirim Universitesi · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Mar 2021, registered Jan 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
74
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Nutritional support is considered a key component of the treatment strategy for intensive care patients. Malnutrition, energy protein, and inadequate or excessive intake of other nutrients have measurable effects on tissues, body structure, body function, and clinical outcomes of patients receiving treatment. It increases hospital-acquired infections, hospitalizations, and intensive care prolongs and leads to complications. This study aimed to observe the time to reach target calories, nutritional failures, and complications during feeding in measured and unmeasured gastric residual volume patients receiving enteral nutrition under ventilation in the intensive care unite.

02

Conditions studied

  • Preventing Malnutrition

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Keywords

  • gastric residual volume
  • malnutrition
  • target calorie
  • intensive care unit
  • enteral nutrition
03

In context

Malnutrition

1,619 studies on the registry are indexed under Malnutrition; 241 are open to participants now.

This study's enrollment of 74 is below the median of 90 across 1,152 interventional studies indexed under Malnutrition.

Browse Malnutrition studies →

Lead sponsor

Erzincan Binali Yildirim Universitesi is the lead sponsor of 23 studies on the registry; 10 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

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

  • Mechanical ventilatory support
  • open enteral route (nasogastric/PEG)

Exclusion criteria

Exclusion Criteria:

  • History of gastrointestinal bleeding,
  • parenteral nutrition support,
  • hospital stay of fewer than two days,
  • under 18 years of age
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
74 participants (actual)

Study arms

  • No intervention
    Gastric residual volume group

    Patients undergoing enteral nutrition with continuous infusion and intermittent gastric residual volume measurement in the intensive care unit

  • Experimental
    Non- Gastric residual volume group

    Patients undergoing enteral nutrition with continuous infusion and intermittent gastric residual volume measurement was not measured in the intensive care unit

    Other: Gastric residual volume measurement stopped.

Interventions

  • OtherGastric residual volume measurement stopped.

    GRV is checked during routine enteral nutrition, but we think that GRV prolongs the time to reach target calories and does not reduce complications.

06

What researchers measure

Primary outcomes

  1. The difference in the time to reach target calories in patients with gastric residual volume measurement compared to those without gastric residual volume measurement.

    The difference in the time to reach target calories in patients with gastric residual volume measurement compared to those without gastric residual volume measurement.

    Time frame: 10 days

07

Study locations

1 site
  • Erzincan Binali Yildirim university
    Erzincan, 24100, Turkey (Türkiye)
08

References and documents

Publications

  • Marik PE. Enteral nutrition in the critically ill: myths and misconceptions. Crit Care Med. 2014 Apr;42(4):962-9. doi: 10.1097/CCM.0000000000000051. PubMed 24296860 ↗
  • Elke G, Felbinger TW, Heyland DK. Gastric residual volume in critically ill patients: a dead marker or still alive? Nutr Clin Pract. 2015 Feb;30(1):59-71. doi: 10.1177/0884533614562841. Epub 2014 Dec 18. PubMed 25524884 ↗

Individual participant data

Plan to share: No

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 Mar 2021 to primary completion in Jan 2022, 10 months.

Of 438 non-industry interventional studies with no phase under Malnutrition, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 34. This study's 10 months is below that.

Counting every sponsor, half of 469 studies reached it within 20 months; a quarter within 10 and three quarters within 34.

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

Registered
Jan 21, 2022
First posted
Feb 14, 2022
StartActual
Mar 1, 2021
Primary completionActual
Jan 1, 2022
CompletionActual
Jan 20, 2022
Last update
Feb 14, 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 Feb 14, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05238051
Lead sponsor
Erzincan Binali Yildirim Universitesi
Responsible party
Alparslan Koc (Principal Investigator, Erzincan University) — Principal investigator
First posted
Feb 14, 2022
Start date
Mar 1, 2021
Primary completion
Jan 1, 2022
Completion
Jan 20, 2022
Last update
Feb 14, 2022

Oversight

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

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This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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