- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05238051
Gastric Residual Volume Measurement in the Intensive Care Unit
February 11, 2022 updated by: Alparslan Koc, Erzi̇ncan Binali Yildırim Uni̇versi̇tesi̇
The Role of Gastric Residual Volume Measurement in Achieving Target Calories in the Intensive Care Unit: A Randomized Controlled Study
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
74
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Erzincan, Turkey, 24100
- Erzincan Binali Yildirim university
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Mechanical ventilatory support
- open enteral route (nasogastric/PEG)
Exclusion Criteria:
- History of gastrointestinal bleeding,
- parenteral nutrition support,
- hospital stay of fewer than two days,
- under 18 years of age
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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
|
GRV is checked during routine enteral nutrition, but we think that GRV prolongs the time to reach target calories and does not reduce complications.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
The difference in the time to reach target calories in patients with gastric residual volume measurement compared to those without gastric residual volume measurement.
|
10 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2021
Primary Completion (Actual)
January 1, 2022
Study Completion (Actual)
January 20, 2022
Study Registration Dates
First Submitted
January 21, 2022
First Submitted That Met QC Criteria
February 11, 2022
First Posted (Actual)
February 14, 2022
Study Record Updates
Last Update Posted (Actual)
February 14, 2022
Last Update Submitted That Met QC Criteria
February 11, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GRVROLE
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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