NCT06113393

Brief Summary

This is a randomized control trial with a parallel design. Eligible patients will be randomly assigned into two groups: a control group which will be holding tube feeding when the GRV reaches 200 mL, and an experimental group will hold tube feeding when the GRV reaches 300 mL. Enteral feeding will be administered according to the study flow chart.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
230

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 22, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 2, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

November 2, 2023

Status Verified

October 1, 2023

Enrollment Period

11 months

First QC Date

October 22, 2023

Last Update Submit

October 31, 2023

Conditions

Critical Illness

Keywords

Enteral nutritionGastric residual volume

Outcome Measures

Primary Outcomes (2)

  • Frequency of diet volume ratio

    1 day (Transfer from the Intensive Care Unit)

  • Incidence of gastrointestinal complications

    Abdominal distension, nausea, vomiting, diarrhea, constipation

    1 day (Transfer from the Intensive Care Unit)

Secondary Outcomes (9)

  • Days of ventilator use

    A week(Transfer from the Intensive Care Unit)

  • Ventilator-associated pneumonia

    1 day (Transfer from the Intensive Care Unit)

  • Length of stay in the intensive care unit

    A week(Transfer from the Intensive Care Unit)

  • Days of parenteral nutrition use

    A week(Transfer from the Intensive Care Unit)

  • Acute Physiology and Chronic Health Evaluation score

    1 day (Transfer from the Intensive Care Unit)

  • +4 more secondary outcomes

Study Arms (2)

control group

NO INTERVENTION

Hold enteral feeding when GRV reaches 200 mL(current standard)

study group

EXPERIMENTAL

Hold enteral feeding when GRV reaches 300 mL(current standard)

Procedure: GRV thresholds

Interventions

GRV thresholdsPROCEDURE

Hold enteral feeding when GRV reaches 200 mL(current standard)

study group

Eligibility Criteria

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

You may qualify if:

  • Adult patients admitted to the internal medicine intensive care unit.
  • Patients receive enteral nutrition through a nasogastric tube.
  • Patients receiving continuous enteral feeding.

You may not qualify if:

  • Patients post-abdominal surgery.
  • Patients admitted to the intensive care unit due to gastrointestinal disorders (e.g., gastrointestinal bleeding, bowel obstruction).
  • Patients receiving palliative care with reduced enteral nutrition.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2023

First Posted

November 2, 2023

Study Start

January 1, 2024

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

November 2, 2023

Record last verified: 2023-10

Locations

TW(1)