Intensive Care Unit SyndromeNCT04977440
High Protein Intake in Critically Ill Ventilated Patients
An observational study of Intensive Care Unit Syndrome, run by Cairo University at 1 site in Egypt.
Trial summary
This prospective interventional randomized control study was conducted on forty patients with respiratory failure; all patients were intubated and mechanically ventilated for at least three days. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intensive Care Unit Syndrome
- What is being tested?
- Whey protein
- Type of treatment
- Injection or infusion
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2020to 1 Feb 2021
- How long will I take part?
- 7 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adult mechanically ventilated patients
Who may be able to join
- Age >18 years
- Mechanically ventilated patients (for three days or more )
Who cannot join
- Age < 18 years old
- Contraindication for enteral nutrition (gut ischemia, obstruction, or perforation)
- Expected intolerance for enteral nutrition (paralytic ileus)
- Inability to start enteral nutrition within 24-hours(i.e. surgery or other interventions)
- Short bowel syndrome
- Hemodynamic instability ( i.e shock state, need for vasopressors )
- Child C liver cirrhosis or acute liver failure
- Dialysis dependency
Trial locations and contacts
1 site in 1 country.
About this study
Official title: High Protein Intake During the Early Phase of Critical Illness Compared With Normal Protein Intake
This prospective interventional randomized control study was conducted on forty patients with respiratory failure; all patients were intubated and mechanically ventilated for at least three days. Twenty patients received high protein intake using whey protein, with daily follow-up of the blood sugar level, serum electrolytes, and chemistry. ICU outcome regarding food intolerance, 30-day mortality, length of MV and ICU-stay was recorded
- Conditions
- Intensive Care Unit Syndrome
- Being tested
- Whey protein
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whey proteinDietary supplement
Patients were randomly divided into two groups: Group (A): Enteral feeding with normal protein intake ( 1.0 gm pin /kg/day ) Group (B): Enteral feeding with high protein intake ( 1.5- gm open /kg/day ) -Patient's- nonprotein- caloric intake was calculated according to REE :(25xactual body weight in kg ) and received it as follow : 1/2 the calculated amount of caloric intake in DAY 1 3/4 of the calculated amount of caloric intake in DAY 2
-Full calculated caloric amount in DAY 3
This regimen was followed long as the patient was tolerating the amount of feeding, and in case of intolerance:
The volume of feeding boluses was decreased or Increase the time interval between boluses or IV metoclopramide or erythromycin was given
| Study group | Role | What they receive |
|---|---|---|
| standard protein | Not described | |
| high protein | Not described Receives: Dietary Supplement: Whey protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of high protein intake on glycemic control
measurements of blood glucose levels regularly after high protein intake
Measured: up to 7 days
Effect of high protein intake on serum electrolytes
measurements of Na, K, Mg, phosphorous and calcium levels regularly after high protein intake
Measured: up to 7 days
Secondary outcomes (1)
Effect of high protein intake on ICU outcome
ICU outcome includes ICU survival , mechanical ventilation , food intolerance
Measured: up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2021
- Study start1 Jan 2020
- Primary completion31 Dec 2020
- Study completion1 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive Care Unit SyndromeStudies of the same condition, open and under way.
- More trials run by Cairo 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
- 40 participants (actual)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Farouk, Cairo University
- Investigators
- farouk faris, MD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04977440
- Sponsor's protocol ID
- MS 29-2020
- Status last verified
- Jul 2021
- First submitted
- 13 Jul 2021
- Last updated
- 27 Jul 2021
- Results posted
- No
- 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 27 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Protein Intake During the Early Phase of Critical Illness Compared With Normal Protein Intake
- ClinicalTrials.gov ID
- NCT04977440
- Acronym / sponsor ID
- MS 29-2020
- Conditions
- Intensive Care Unit Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 27 Jul 2021 (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.
This prospective interventional randomized control study was conducted on forty patients with respiratory failure; all patients were intubated and mechanically ventilated for at least three days. Twenty patients received high protein intake using whey protein, with daily follow-up of the blood sugar level, serum electrolytes, and chemistry. ICU outcome regarding food intolerance, 30-day mortality, length of MV and ICU-stay was recorded
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard protein | – | – |
| high protein | – | Dietary Supplement: Whey protein |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult mechanically ventilated patients
Key inclusion criteria (2 listed)
- Age >18 years
- Mechanically ventilated patients (for three days or more )
Key exclusion criteria (8 listed)
- Age < 18 years old
- Contraindication for enteral nutrition (gut ischemia, obstruction, or perforation)
- Expected intolerance for enteral nutrition (paralytic ileus)
- Inability to start enteral nutrition within 24-hours(i.e. surgery or other interventions)
- Short bowel syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whey proteinPatients were randomly divided into two groups: Group (A): Enteral feeding with normal protein intake ( 1.0 gm pin /kg/day ) Group (B): Enteral feeding with high protein intake ( 1.5- gm open /kg/day ) -Patient's- nonprotein- caloric intake was calculated according to REE :(25xactual body weight in kg ) and received it as follow : 1/2 the calculated amount of caloric intake in DAY 1 3/4 of the calculated amount of caloric intake in DAY 2 -Full calculated caloric amount in DAY 3 This regimen was followed long as the patient was tolerating the amount of feeding, and in case of intolerance: The volume of feeding boluses was decreased or Increase the time interval between boluses or IV metoclopramide or erythromycin was given | Dietary supplement | high protein |
Primary outcome
Effect of high protein intake on glycemic control
Time frame: up to 7 days
measurements of blood glucose levels regularly after high protein intake
Effect of high protein intake on serum electrolytes
Time frame: up to 7 days
measurements of Na, K, Mg, phosphorous and calcium levels regularly after high protein intake
1 secondary outcome
Effect of high protein intake on ICU outcome
Time frame: up to 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2021.
- 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.
farouk faris, MD principal investigator
Cairo University
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 Intensive Care Unit Syndrome, run by Cairo 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 2 inclusion and 8 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: finished, as of the sponsor's last update on 27 Jul 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Effect of high protein intake on glycemic control (time frame: up to 7 days). 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 27 Jul 2021.