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Gastric Residual Volume Measurement in the Intensive Care Unit

Primary Purpose

Preventing Malnutrition

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Gastric residual volume measurement stopped.
Sponsored by
Erzi̇ncan Binali Yildirim Uni̇versi̇tesi̇
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Preventing Malnutrition focused on measuring gastric residual volume, malnutrition, target calorie, intensive care unit, enteral nutrition

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Erzincan Binali Yildirim university

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Gastric residual volume group

Non- Gastric residual volume group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
January 21, 2022
Last Updated
February 11, 2022
Sponsor
Erzi̇ncan Binali Yildirim Uni̇versi̇tesi̇
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1. Study Identification

Unique Protocol Identification Number
NCT05238051
Brief Title
Gastric Residual Volume Measurement in the Intensive Care Unit
Official Title
The Role of Gastric Residual Volume Measurement in Achieving Target Calories in the Intensive Care Unit: A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
January 1, 2022 (Actual)
Study Completion Date
January 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Erzi̇ncan Binali Yildirim Uni̇versi̇tesi̇

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preventing Malnutrition
Keywords
gastric residual volume, malnutrition, target calorie, intensive care unit, enteral nutrition

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gastric residual volume group
Arm Type
No Intervention
Arm Description
Patients undergoing enteral nutrition with continuous infusion and intermittent gastric residual volume measurement in the intensive care unit
Arm Title
Non- Gastric residual volume group
Arm Type
Experimental
Arm Description
Patients undergoing enteral nutrition with continuous infusion and intermittent gastric residual volume measurement was not measured in the intensive care unit
Intervention Type
Other
Intervention Name(s)
Gastric residual volume measurement stopped.
Intervention Description
GRV is checked during routine enteral nutrition, but we think that GRV prolongs the time to reach target calories and does not reduce complications.
Primary Outcome Measure Information:
Title
The difference in the time to reach target calories in patients with gastric residual volume measurement compared to those without gastric residual volume measurement.
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Erzincan Binali Yildirim university
City
Erzincan
ZIP/Postal Code
24100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24296860
Citation
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.
Results Reference
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PubMed Identifier
25524884
Citation
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.
Results Reference
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Gastric Residual Volume Measurement in the Intensive Care Unit

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