NCT06511284

Brief Summary

The aim of this study is to evaluate the impact of the prescription of two doses of protein on the amount in kilograms of muscle mass and on the clinical evolution (time until safe swallowing, time until removal of the feeding stoma, number of hospital readmissions, feeding stoma infections, incidence of pneumonia, functionality, number of falls, fractures and mortality) at 6 months after hospital discharge in patients with enteral nutrition due to post-extubation dysphagia.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
19mo left

Started Jul 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress54%
Jul 2024Dec 2027

Study Start

First participant enrolled

July 1, 2024

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

July 10, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 19, 2024

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2026

Expected
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

July 19, 2024

Status Verified

July 1, 2024

Enrollment Period

2.5 years

First QC Date

July 10, 2024

Last Update Submit

July 15, 2024

Conditions

Dysphagia

Keywords

enteral nutritionnutritional assessmentnutritional therapyDeglutition Disordersrehabilitation

Outcome Measures

Primary Outcomes (1)

  • Muscle mass changes

    Changes of muscle mass in kilograms measured by impedance bioelectric

    From randomization to 6 months

Secondary Outcomes (9)

  • Swallow recovery

    From randomization to 6 months

  • Duration of enteral nutrition indication

    From randomization to 6 months

  • Feeding tube complications

    From randomization to 6 months

  • Muscle functionality changes

    From randomization to 6 months

  • Handgrip strenght changes

    From randomization to 6 months

  • +4 more secondary outcomes

Study Arms (2)

High protein group

EXPERIMENTAL

100% of the energy requirements measured by indirect calorimetry (IC) or estimated, and a protein intake of 2.0 g/kg, will be prescribed

Other: High protein dose

Usual protein group

OTHER

100% of the energy requirements measured by IC or estimated, and a protein intake of 1.5 g/kg, will be prescribed.

Other: Usual protein dose

Interventions

High protein doseOTHER

High dose of protein (2.0 g/kg) will prescribed for home enteral nutrition

High protein group
Usual protein doseOTHER

Usual dose of protein (1.5 g/kg) will prescribed for home enteral nutrition

Usual protein group

Eligibility Criteria

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

You may qualify if:

  • Patients who required invasive mechanical ventilation during their hospital stay with a diagnosis of post-extubation dysphagia diagnosed by fibroendoscopy evaluation of swallowing (FEES).
  • Patients who discharged with a feeding tube.
  • Patients with signed informed consent.

You may not qualify if:

  • Patients with pre-existing dysphagia, or with neurological conditions that can cause dysphagia (e.g. multiple sclerosis, Parkinson's disease, Alzheimer's, myasthenia gravis).
  • Patients with chronic kidney disease, defined as a glomerular filtration rate \<60 ml/min.
  • Patients discharged with a terminal condition and/or life expectancy of less than 3 months.
  • Diagnosis of HIV, upon receiving clinical follow-up by the team of specialists.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Respiratory Diseases

Mexico City, 14080, Mexico

RECRUITING

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Ivan A Osuna-Padilla, PhD

    Instituto Nacional de Enfermedades Respiratorias

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ivan A Osuna-Padilla, PhD

CONTACT

+5216671035806ivan.osuna@iner.gob.mx

Alan Garcia-Grimaldo, MSc

CONTACT

agarciag1716@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Amounts of protein was not revealed for participants
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized Clinical Trial
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Nutrition Manager

Study Record Dates

First Submitted

July 10, 2024

First Posted

July 19, 2024

Study Start

July 1, 2024

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

December 1, 2027

Last Updated

July 19, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

ME(1)