Mechanically Ventilated PatientsNCT07634328
Impact of a High-Protein Diet on Clinical Outcomes in Mechanically Ventilated Patients With Severe Pneumonia
An observational study of Mechanically Ventilated Patients and Severe Pneumonia, run by Fayoum University at 1 site in Egypt.
Trial summary
prospective, comparative, observational study will be conducted at the Critical Care Department, Fayoum University Hospital, to evaluate the impact of a high-protein diet versus a standard-protein diet in mechanically ventilated patients with severe pneumonia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanically Ventilated Patients, Severe Pneumonia
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 9 Oct 2025to 1 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: mechanically ventilated patients with severe pneumonia
Who may be able to join
- Age ≥ 18 years.
- Mechanically ventilated patients with severe pneumonia.
- Expected ICU stay ≥ 72 hours.
Who cannot join
- Patients who died before 72 hours of ICU admission.
- Chronic liver failure or decompensated cirrhosis.
- End-stage renal disease (CKD stage 5 or dialysis dependent).
- Neuromuscular diseases or pre-existing severe muscle wasting.
- Pregnancy.
- Patients with pre-existing malnutrition (e.g., BMI <18.5 kg/m² ).
Show all 11Show fewer
- Contraindications to enteral feeding, such as:
- Mechanical bowel obstruction.
- Severe gastrointestinal bleeding.
- High-output fistulas involving the gastrointestinal tract.
- Recent gastrointestinal surgery preventing enteral access.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of medicine Fayoum university
Al Fayyum, Faiyum Governorate, 63514
About this study
prospective, comparative, observational study will be conducted at the Critical Care Department, Fayoum University Hospital, to evaluate the impact of a high-protein diet versus a standard-protein diet in mechanically ventilated patients with severe pneumonia.
Read the detailed description
prospective, comparative, observational study will be conducted at the Critical Care Department, Fayoum University Hospital, aims to evaluate the effect of a high-protein diet on clinical outcomes in mechanically ventilated patients with severe pneumonia, focusing on muscle preservation and weaning ability. The specific objectives are:
- To assess the impact of high-protein intake on skeletal muscle mass using quadriceps ultrasound.
- To evaluate diaphragmatic function and thickness in relation to protein intake using ultrasound.
- To determine the effect of high-protein nutrition on weaning success, duration of mechanical ventilation, length of hospital stay and mortality.
- Conditions
- Mechanically Ventilated Patients, Severe Pneumonia
- Keywords
- high-protein diet, quadriceps ultrasound, severe pneumonia
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| High-protein group | Group of mechanically ventilated patients with severe pneumonia that will receive Protein intake 2.0 g/kg/day. | |
| Standard-protein group | Group of mechanically ventilated patients with severe pneumonia that will receive Protein intake 1.2 g/kg/day. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of mechanical ventilation
The total time in days during which the patient receives invasive mechanical ventilatory support through an endotracheal tube or tracheostomy, calculated from the initiation of mechanical ventilation until successful liberation from the ventilator or death.
Measured: From enrollment to the end of treatment at 1 to 2 weeks
Weaning Success
Successful discontinuation of mechanical ventilatory support with maintenance of spontaneous breathing after extubation, without the need for re-intubation, reinstitution of invasive mechanical ventilation, or death within 48 hours.
Measured: 1 to 2 weeks
Secondary outcomes (5)
Preservation of Quadriceps Muscle Mass Assessed by Ultrasound
Preservation of quadriceps muscle mass was assessed using bedside ultrasonography by measuring the quadriceps muscle thickness at predefined anatomical landmarks. Muscle preservation was defined as the percentage change in muscle thickness from baseline to the follow-up assessment, with a smaller reduction indicating better preservation of muscle mass.
Measured: 2 weeks
Diaphragm Muscle Thickness Assessed by Ultrasound
Diaphragm muscle thickness was assessed using bedside ultrasonography in the zone of apposition of the diaphragm. The thickness of the diaphragm measured by ultrasound at the zone of apposition, expressed in millimeters (mm). Measurements were obtained at end-expiration, and the percentage change from baseline was used to assess diaphragm muscle preservation or atrophy.
Diaphragm Thickening Fraction (DTF) (%)=(DT at end-inspiration - DT at end-expiration) ÷ DT at end-expiration × 100.
TF ≥ 20% is considered normal; < 20% suggests diaphragmatic dysfunction.
Measured: 2 weeks
Incidence of ICU-Acquired Weakness
The percentage of patients who develop ICU-acquired weakness during ICU admission. ICU-AW was diagnosed when the MRC sum score was <48/60 during ICU admission.
Measured: 1 to 4 weeks
ICU Length of Stay
The number of days spent in the ICU, calculated from ICU admission to ICU discharge, transfer to another ward, or death during ICU stay.
Measured: 2 to 4 weeks
Mortality
The proportion of patients who die during their ICU stay, calculated from ICU admission until ICU discharge.
Measured: 2 to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study start9 Oct 2025
- Primary completion9 Sep 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanically Ventilated PatientsStudies of the same condition, open and under way.
- More trials run by Fayoum UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fayoum University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Abdelnabi Abdelhalim Ahmed, Fayoum University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07634328
- Sponsor's protocol ID
- M846
- Status last verified
- Oct 2025
- First submitted
- 3 Jun 2026
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a High-Protein Diet on Clinical Outcomes in Mechanically Ventilated Patients With Severe Pneumonia
- ClinicalTrials.gov ID
- NCT07634328
- Acronym / sponsor ID
- M846
- Conditions
- Mechanically Ventilated Patients, Severe Pneumonia
- Keywords
- high-protein diet, quadriceps ultrasound, severe pneumonia
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fayoum UniversityUniversity, hospital or other
- Study start
- 9 Oct 2025 (actual)
- Primary completion
- 9 Sep 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 8 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
prospective, comparative, observational study will be conducted at the Critical Care Department, Fayoum University Hospital, to evaluate the impact of a high-protein diet versus a standard-protein diet in mechanically ventilated patients with severe pneumonia.
Detailed description
prospective, comparative, observational study will be conducted at the Critical Care Department, Fayoum University Hospital, aims to evaluate the effect of a high-protein diet on clinical outcomes in mechanically ventilated patients with severe pneumonia, focusing on muscle preservation and weaning ability. The specific objectives are:
- To assess the impact of high-protein intake on skeletal muscle mass using quadriceps ultrasound.
- To evaluate diaphragmatic function and thickness in relation to protein intake using ultrasound.
- To determine the effect of high-protein nutrition on weaning success, duration of mechanical ventilation, length of hospital stay and mortality.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-protein group | – | –Group of mechanically ventilated patients with severe pneumonia that will receive Protein intake 2.0 g/kg/day. |
| Standard-protein group | – | –Group of mechanically ventilated patients with severe pneumonia that will receive Protein intake 1.2 g/kg/day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- mechanically ventilated patients with severe pneumonia
Key inclusion criteria (3 listed)
- Age ≥ 18 years.
- Mechanically ventilated patients with severe pneumonia.
- Expected ICU stay ≥ 72 hours.
Key exclusion criteria (11 listed)
- Patients who died before 72 hours of ICU admission.
- Chronic liver failure or decompensated cirrhosis.
- End-stage renal disease (CKD stage 5 or dialysis dependent).
- Neuromuscular diseases or pre-existing severe muscle wasting.
- Pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Duration of mechanical ventilation
Time frame: From enrollment to the end of treatment at 1 to 2 weeks
The total time in days during which the patient receives invasive mechanical ventilatory support through an endotracheal tube or tracheostomy, calculated from the initiation of mechanical ventilation until successful liberation from the ventilator or death.
Weaning Success
Time frame: 1 to 2 weeks
Successful discontinuation of mechanical ventilatory support with maintenance of spontaneous breathing after extubation, without the need for re-intubation, reinstitution of invasive mechanical ventilation, or death within 48 hours.
5 secondary outcomes
Preservation of Quadriceps Muscle Mass Assessed by Ultrasound
Time frame: 2 weeks
Diaphragm Muscle Thickness Assessed by Ultrasound
Time frame: 2 weeks
Incidence of ICU-Acquired Weakness
Time frame: 1 to 4 weeks
ICU Length of Stay
Time frame: 2 to 4 weeks
Mortality
Time frame: 2 to 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mechanically Ventilated Patients and Severe Pneumonia, run by Fayoum University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of mechanical ventilation (time frame: From enrollment to the end of treatment at 1 to 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.