Evaluation of Diaphragmatic Function and Quadriceps Muscle Thickness in Patients Receiving High Protein Nutrition

NCT06025760 | Unknown

• 1 other identifier: IRB#9659
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

Brief Summary

Different Protein Doses' Effect on Diaphragmatic Function and Quadriceps Thickness

Conditions

ICU Acquired Weakness

Outcome Measures

Primary Outcomes (1)

• To assess the effect of different protein doses (1.2 gm/kg per day versus 2 gm/kg per day ) on diaphragmatic muscle function in mechanically ventilated patients in ICU for 4 weeks.

  assessment of the effect of different protein doses per day on diaphragmatic muscle function in mechanically ventilated patients using ultrasound, the following data will be assessed: 1. Diaphragm thickness (mm) on days (0, 3, 5, and 7 from ICU admission then weekly till the fourth week ). 2. Diaphragm thickening fraction on the day (0, 3, 5, 7 then weekly till the fourth week ) 3. Diaphragm excursion during the weaning trial during spontaneous breathing trial (SBT).

  from time of ICU admission on day 0,then on days 3, 5, 7, then weekly till the fourth week.

Secondary Outcomes (1)

• To assess the effect of different protein doses (1.2 gm/kg per day versus 2 gm/kg per day ) on Quadriceps muscle thickness(mm) in mechanically ventilated patients in ICU for 4 weeks.

  from time of ICU admission on day 0, then on days 3, 5, 7, then weekly till the fourth week

Study Arms (2)

Interventional group

ACTIVE COMPARATOR

Mechanically ventilated patients will receive a nutritional caloric intake of 25-30 kcal/kg/day with a high protein dose of 2 gm protein /kg/day within 24 hours of ICU admission.

Other: patients who will receive 2 gm protein/kg/day will be evaluated by ultrasound for diaphragmatic function and quadriceps muscle thickness

Control group

PLACEBO COMPARATOR

patients will receive a nutritional caloric intake of 25-30 kcal/kg/day with a standard protein dose of 1.2 gm protein /kg/day within 24 hours of ICU admission.

Other: patients who will receive 2 gm protein/kg/day will be evaluated by ultrasound for diaphragmatic function and quadriceps muscle thickness

Interventions

patients who will receive 2 gm protein/kg/day will be evaluated by ultrasound for diaphragmatic function and quadriceps muscle thickness OTHER

All patients after ICU admission will be started enteral nutrition through a nasogastric tube within 24-48 hours. The target caloric intake is 25-30 kcal/kg/day. patients in the interventional group will receive 2 gm protein/kg/day, while patients in the control group will receive 1.2 gm protein/kg/day. Quadriceps thickness and Diaphragm thickening fraction will be assessed by ultrasound from the time of admission on days 0, 3, 5, and 7 then weekly till the fourth week.

Also known as: patients who will receive 1.2 gm protein/kg/day will be evaluated by ultrasound for diaphragmatic function and quadriceps muscle thickness in

Control group; Interventional group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Acceptance of the first-degree relatives.
• Critically ill patients: patients with a life-threatening condition that requires pharmacological and/or mechanical support of vital organ functions without which death would be imminent.
• Patients anticipated to be mechanically ventilated for ≥ 48 hours
• Patients who expected ICU stay ≥ 4 weeks
• Patients aged between 18 - 60 years of both sexes.
• Patient nutrition risk screening (NRS 2002) score ≥ 3
• Patient BMI less than 35
• No contraindication to early enteral nutrition.

You may not qualify if:

• Patient with Trauma to both lower extremities, diaphragm disease (trauma, immobilization….), myopathy, and moderate to severe hepatic insufficiency.
• Patient receiving steroids.
• Patient on renal replacement therapy.
• Prior MV before admission.
• Pregnant.
• Patient with neuromuscular disease, spinal cord injury, thoracic deformity, and respiratory restriction.
• Patients require muscle paralysis on MV.
• Patients require high dose inotrope or vasopressor.

Sponsors & Collaborators

• Zagazig University: lead

Study Officials

• Ghada Abdelrazik, professor

  Professor of anesthesia, intensive care and pain managment

  STUDY CHAIR

• Neven Gamil, professor

  Professor of anesthesia, intensive care and pain managment

  STUDY CHAIR

• Naglaa Abdelhaleem, Lecturer

  lecturer of anesthesia, intensive care and pain managment

  STUDY CHAIR

• Ayman Amer, professor

  Professor of diagnostic radiology

  STUDY CHAIR

Central Study Contacts

Mahmoud Aboulaban, A. Lecturer

CONTACT

01013015577; mahmoudaboulaban@gmail.com

Naglaa Abdelhaleem, MD

CONTACT

01003103036; nogaahmedkareem.fa@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of anesthesia and ICU

Model Details: Critically ill mechanically ventilated patients will receive protein of 2 gm/kg/day in the interventional group. Critically ill mechanically ventilated patients will receive protein of 1.2 gm/kg/day in the control group.

Study Record Dates

• First Submitted: December 6, 2022
• First Posted: September 6, 2023
• Study Start: October 1, 2023
• Primary Completion: October 1, 2024
• Study Completion: November 1, 2024
• Last Updated: September 14, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share