NCT05238051

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2022

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

January 21, 2022

Completed
24 days until next milestone

First Posted

Study publicly available on registry

February 14, 2022

Completed
Last Updated

February 14, 2022

Status Verified

February 1, 2022

Enrollment Period

10 months

First QC Date

January 21, 2022

Last Update Submit

February 11, 2022

Conditions

Keywords

gastric residual volumemalnutritiontarget calorieintensive care unitenteral nutrition

Outcome Measures

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.

    10 days

Study Arms (2)

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

Other: Gastric residual volume measurement stopped.

Interventions

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

Non- Gastric residual volume group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erzincan Binali Yildirim university

Erzincan, 24100, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

    PMID: 24296860BACKGROUND
  • 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.

    PMID: 25524884BACKGROUND

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 21, 2022

First Posted

February 14, 2022

Study Start

March 1, 2021

Primary Completion

January 1, 2022

Study Completion

January 20, 2022

Last Updated

February 14, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations