Preventing MalnutritionNCT05238051
Gastric Residual Volume Measurement in the Intensive Care Unit
A study testing Gastric residual volume measurement stopped. in people with Preventing Malnutrition, run by Erzincan Binali Yildirim Universitesi at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Preventing Malnutrition
- What is being tested?
- Gastric residual volume measurement stopped.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2021to 20 Jan 2022
- Phase
- Interventional
- 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
Who may be able to join
- Mechanical ventilatory support
- open enteral route (nasogastric/PEG)
Who cannot join
- History of gastrointestinal bleeding,
- parenteral nutrition support,
- hospital stay of fewer than two days,
- under 18 years of age
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Erzincan Binali Yildirim university
Erzincan, 24100
About this study
Official title: 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.
- Conditions
- Preventing Malnutrition
- Being tested
- Gastric residual volume measurement stopped.
- Keywords
- gastric residual volume, malnutrition, target calorie, intensive care unit, enteral nutrition
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastric residual volume measurement stopped.Other
GRV is checked during routine enteral nutrition, but we think that GRV prolongs the time to reach target calories and does not reduce complications.
| Study group | Role | What they receive |
|---|---|---|
| Gastric residual volume group | No intervention | Patients undergoing enteral nutrition with continuous infusion and intermittent gastric residual volume measurement in the intensive care unit |
| Non- Gastric residual volume group | Experimental | Patients undergoing enteral nutrition with continuous infusion and intermittent gastric residual volume measurement was not measured in the intensive care unit Receives: Other: Gastric residual volume measurement stopped. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2022
- Study start1 Mar 2021
- Primary completion1 Jan 2022
- Study completion20 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Preventing MalnutritionStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Gastric residual volume (GRV) was measured in one group and not in the other. Nutrition was started at an infusion rate of 20 ml/hour in the GRV group. The GRV was measured every four hours. When it was less than 200 ml, the infusion rate was increased by 20 ml/hour. The infusion rate, which was increased every four hours according to the GRV, was continued constantly when the target calorie was reached. It was kept constant when the GRV was above 200 ml, and then the feeding rate was reduced to half when the GRV volume was above 400 ml. In four patients, enteral nutrition was discontinued due to melena and excluded from the study. In six patients with persistently high GRV values, enteral nutrition was discontinued and parenteral nutrition initiated. The study was completed with 62 patients. GRV (n=31) and Non-GRV (n=31).
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erzincan Binali Yildirim Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alparslan Koc, Erzincan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05238051
- Sponsor's protocol ID
- GRVROLE
- Status last verified
- Feb 2022
- First submitted
- 21 Jan 2022
- Last updated
- 14 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 24296860Elke 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
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Gastric Residual Volume Measurement in Achieving Target Calories in the Intensive Care Unit: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05238051
- Acronym / sponsor ID
- GRVROLE
- Conditions
- Preventing Malnutrition
- Keywords
- gastric residual volume, malnutrition, target calorie, intensive care unit, enteral nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Erzincan Binali Yildirim UniversitesiUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 20 Jan 2022 (actual)
- First posted
- 14 Feb 2022 (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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Gastric residual volume (GRV) was measured in one group and not in the other. Nutrition was started at an infusion rate of 20 ml/hour in the GRV group. The GRV was measured every four hours. When it was less than 200 ml, the infusion rate was increased by 20 ml/hour. The infusion rate, which was increased every four hours according to the GRV, was continued constantly when the target calorie was reached. It was kept constant when the GRV was above 200 ml, and then the feeding rate was reduced to half when the GRV volume was above 400 ml. In four patients, enteral nutrition was discontinued due to melena and excluded from the study. In six patients with persistently high GRV values, enteral nutrition was discontinued and parenteral nutrition initiated. The study was completed with 62 patients. GRV (n=31) and Non-GRV (n=31).
| Arm | Type | Receives |
|---|---|---|
| Gastric residual volume group | No intervention | –Patients undergoing enteral nutrition with continuous infusion and intermittent gastric residual volume measurement in the intensive care unit |
| Non- Gastric residual volume group | Experimental | Other: Gastric residual volume measurement stopped.Patients undergoing enteral nutrition with continuous infusion and intermittent gastric residual volume measurement was not measured in the intensive care unit |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Mechanical ventilatory support
- open enteral route (nasogastric/PEG)
Key exclusion criteria (4 listed)
- History of gastrointestinal bleeding,
- parenteral nutrition support,
- hospital stay of fewer than two days,
- under 18 years of age
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 |
|---|---|---|
| Gastric 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. | Other | Non- Gastric residual volume group |
Primary outcome
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.
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 14 Feb 2022.
- Background: PubMed 24296860Marik PE. Enteral nutrition in the critically ill: myths and misconceptions. Crit Care Med. 2014 Apr;42(4):962-9. doi: 10.1097/CCM.0000000000000051.
- Background: PubMed 25524884Elke 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.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gastric residual volume measurement stopped. in people with Preventing Malnutrition, run by Erzincan Binali Yildirim Universitesi at 1 site in Turkey (Türkiye).
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 2 inclusion and 4 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 14 Feb 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 Turkey (Türkiye). 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?
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). 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 NCT05238051, which also lists 2 linked publications.
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 14 Feb 2022.