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

NCT ID: NCT06025760

Last Updated: 2023-09-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-01
• Study Completion Date: 2024-11-01

Brief Summary

Different Protein Doses' Effect on Diaphragmatic Function and Quadriceps Thickness

Detailed Description

Nutrition therapy is no longer a support method for critically ill patients but is considered an important treatment measure. Increasing the protein and energy available to patients in the intensive care unit (ICU) reduces infection and complications, increases ventilator-free days, increases long-term physical recovery, and lowers patient mortality Among critically ill patients, protein is the most important macronutrient because it promotes healing, improves immune function, and helps patients maintain their lean body mass. Growing evidence has shown that adequate protein intake may be more important than caloric intake in the body. In addition, reaching at least 80% of the prescribed protein intake rather than energy intake is related to improved survival rates in ICU patients.

Muscular atrophy is a common feature in patients with intensive care unit-acquired weakness (ICU-AW), and it can start in the early stages of critical illness (within hours of onset of the disease). Its development has been related to the acute inflammatory process and immobilization. Factors such as age, medications, comorbidities, nutrition, and nervous, and muscular damage before critical illness can contribute to the extent of atrophy and the muscular and functional recovery capacity.

It was believed that perhaps the respiratory muscles in humans were spared any loss of muscle protein during starvation because of their constant activity. In a necropsy study designed to assess the diaphragm in health and disease, it was found that alterations in body weight and muscularity profoundly affect the diaphragm muscle mass.

Mechanical ventilation (MV) is the most important life-sustaining measure for critically ill patients, Even if the MV is maintained for a short time, diaphragm fatigue may also occur owing to atrophy or decreased contractile function, which is known as ventilator-induced diaphragm dysfunction (VIDD). Pathophysiological changes of VIDD include muscle atrophy, structural damage, and fiber-type transformation and remodeling.VIDD is the main factor contributing to difficult weaning from long-term MV in critically ill patients. Prolonging the time of MV is associated with an increased risk of complications, long-term dysfunction, and death.

Muscles of the lower limb are more prone to early atrophy as they are weight-bearing compared to the muscles of the upper limb as shown in previous studies. The authors showed that the size of the flexor compartment of the elbow did not show any change in the first 10 days of admission, whereas the size of the anterior compartment muscles of the lower limb showed a greater decrease in thickness within the first 5 days. Thus, these muscles make a good choice for muscle mass assessment.

Point-of-care ultrasound (POCUS) is rapid, accurate, repeatable, nonexpensive, noninvasive, and without the risk of radiation. It can visualize a large muscle area and deeper-located muscles. It can be used in both stable and unstable patients. Performing repeated ultrasound examinations in critical patients is essential and improves the overall sensitivity of the examination, which has become a standard of care in critical care.

One of the unsolved problems for a reliable definition of protein goals is the optimal intake timing to reach predefined therapeutic goals. European Society for Clinical Nutrition and Metabolism (ESPEN) 2009 recommended protein dose to be 1.2 - 1.5 gm /kg/day, while recent ESPEN 2019 guidelines recommend a dose of 1.3 gm/kg/day. On the other hand, the American Society for Parenteral and Enteral Nutrition (ASPEN) 2016 and ASPEN 2022 recommend a dose of 1.2- 2 gm/kg/day.

Generally, it is well known that patients in the acute phase (ebb phase) of the stress response are less capable of utilizing nutrients, thereby implying that early high-dose protein administration might not be beneficial. In the later phase (flow phase) of metabolic stress, insulin sensitivity gradually improves, and the human body's capability to metabolize exogenous substrates increases accordingly.

Conditions

ICU Acquired Weakness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Interventional group

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.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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.

Control group

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.

Group Type: PLACEBO_COMPARATOR

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

Intervention Type: 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.

Interventions

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

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.

Intervention Type: OTHER

Other Intervention Names

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

Eligibility Criteria

Inclusion Criteria

• • 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.

Exclusion Criteria

• • 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zagazig University

OTHER_GOV

Sponsor Role: lead

Responsible Party

Naglaa Fathy Abdelhaleem Abdelhaleem

Lecturer of anesthesia and ICU

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ghada Abdelrazik, professor

Role: STUDY_CHAIR

Professor of anesthesia, intensive care and pain managment

Neven Gamil, professor

Role: STUDY_CHAIR

Professor of anesthesia, intensive care and pain managment

Naglaa Abdelhaleem, Lecturer

Role: STUDY_CHAIR

lecturer of anesthesia, intensive care and pain managment

Ayman Amer, professor

Role: STUDY_CHAIR

Professor of diagnostic radiology

Central Contacts

Mahmoud Aboulaban, A. Lecturer

Role: CONTACT

mahmoudaboulaban@gmail.com

01013015577

Naglaa Abdelhaleem, MD

Role: CONTACT

nogaahmedkareem.fa@gmail.com

01003103036

Other Identifiers

IRB#9659

Identifier Type: -

Identifier Source: org_study_id