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Search / Trial NCT06025760

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

Launched by ZAGAZIG UNIVERSITY · Sep 2, 2023

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This clinical trial is looking at how different amounts of protein in nutrition can affect the strength of the diaphragm (the muscle that helps you breathe) and the thickness of the quadriceps (the muscle at the front of your thigh) in patients who are critically ill and may develop weakness while in the ICU. The goal is to see if providing more protein helps these patients recover better.

To participate, patients must be between 18 and 60 years old, expect to be on a ventilator for at least 48 hours, and likely stay in the ICU for four weeks or longer. They should also have a certain level of nutrition risk. However, there are some criteria that would exclude certain patients, such as those with severe liver disease or who are pregnant. This trial is not recruiting participants yet, but it aims to understand how nutrition can support recovery in critically ill patients.

Gender

ALL

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.

About Zagazig University

Zagazig University, a prominent educational and research institution located in Egypt, plays a pivotal role in advancing medical knowledge and promoting health innovations through its clinical trials. With a commitment to excellence in research, the university leverages its diverse expertise and state-of-the-art facilities to conduct rigorous clinical studies that aim to improve patient care and outcomes. By fostering collaboration among multidisciplinary teams, Zagazig University contributes significantly to the global medical community, ensuring that its clinical trials adhere to the highest ethical standards and regulatory requirements.

Locations

Patients applied

0 patients applied

Trial Officials

Ghada Abdelrazik, professor

Study Chair

Professor of anesthesia, intensive care and pain managment

Neven Gamil, professor

Study Chair

Professor of anesthesia, intensive care and pain managment

Naglaa Abdelhaleem, Lecturer

Study Chair

lecturer of anesthesia, intensive care and pain managment

Ayman Amer, professor

Study Chair

Professor of diagnostic radiology

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported