Hand Muscle StrainNCT04961866
Effects of Parenteral Protein Concentrations in Critically Ill Patients
A study testing parenteral protein 1 g/kg and Parenteral nutrition 2 g/kg in people with Hand Muscle Strain, run by Minia University at 1 site in Egypt.
Trial summary
Sixty patients who need Parenteral nutrition for more than 48h will be assigned into two groups .Group A (n=30) patient will receive 1g/kg/day protein and group B n=30) patient will receive 2g /kg/day. In both groups caloric requirement will be fixed at 25- 30 kcal /kg/d. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hand Muscle Strain
- What is being tested?
- parenteral protein 1 g/kg and Parenteral nutrition 2 g/kg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2020to 1 Mar 2021
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: from 18 to 70 years Sex : male or female Predicted to be in icu ≥ 48 hs Predicted to have PN for> 48 hs.
Who cannot join
- Hepatic patients Renal patients Age <18 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Parenteral Protein Concentrations in Critically Ill Patients in Icu (Comparative Study)
Sixty patients who need Parenteral nutrition for more than 48h will be assigned into two groups .Group A (n=30) patient will receive 1g/kg/day protein and group B n=30) patient will receive 2g /kg/day. In both groups caloric requirement will be fixed at 25- 30 kcal /kg/d.
Read the detailed description
In this study after obtaining approval from our hospital ethics committee, a written informed consent will be obtained from patient's next of kin.
Sixty patients who need PN for more than 48h will be assigned into two groups .Group A (n=30) patient will receive 1g/kg/day protein and group B n=30) patient will receive 2g /kg/day. In both groups caloric requirement will be fixed at 25- 30 kcal /kg/d.
Inclusion criteria:
Age: from 18 to 60 years Sex : male or female Predicted to be in icu ≥ 48 hs Predicted to have PN for> 48 hs.
Exclusion criteria:
Pregnant female Hepatic patients Renal patients Age <18 years
Technique of the study :
60 abdominal surgery/trauma ICU patients who have a contraindication or intolerance to enteral nutrition(EN),will be fed parenterally within 24-48 h from admission and divided according to the protein delivery into two groups.
Group A , those patients will receive parenteral proteins in a dose of 1 g/kg/day.
Group B, those patients will receive parenteral proteins in a dose of 2g/kg /day The nutrition will be delivered through a central line and using separate bottles technique ,because of the lack of a compounding unit and commercial bags in our hospital, After exclusion of the protein calories (will be given as 10%aa )the rest of energy requirement will be divided between carbohydrates (glucose25%)and lipids(SMOF20%) in a ratio of 60:40 Serum electrolytes, blood glucose, lipid profile and serum creatinine will be monitored and corrected regularly in every patient
The two groups will be compared as regarding the following :
hand grip strength Time of staying on Icu Time of staying in hospital Ultrasound biceps muscle thickness Nitrogen balances
- Conditions
- Hand Muscle Strain
- Being tested
- parenteral protein 1 g/kg, Parenteral nutrition 2 g/kg
- Keywords
- protein, parenteral, critical ill patient, ICU
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
parenteral protein 1 g/kgDietary supplement
patients received 1 g/ kg of protein
Parenteral nutrition 2 g/kgDietary supplement
Patients received 2 g/ kg of protein
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | patients received 1 g/ kg of protein Receives: Dietary Supplement: parenteral protein 1 g/kg |
| Group B | Active comparator | patients received 2 g/ kg of protein Receives: Dietary Supplement: Parenteral nutrition 2 g/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
hand grip strength
hand grip strength using dynamometer
Measured: 10 days
Secondary outcomes (2)
ultrasound guided muscle thickness
us guided biceps and forearm muscle thickness
Measured: 10 days
nitrogen balances
Measurements
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2021
- Study start1 Jan 2020
- Primary completion1 Mar 2021
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand Muscle StrainStudies of the same condition, open and under way.
- More trials run by Minia 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karim Naser Hasan, Minia University
- Investigators
- Ibrahim A. Youssif, MD, Study chair, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04961866
- Sponsor's protocol ID
- 308:10/2019
- Status last verified
- Aug 2021
- First submitted
- 28 Jun 2021
- Last updated
- 10 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Parenteral Protein Concentrations in Critically Ill Patients in Icu (Comparative Study)
- ClinicalTrials.gov ID
- NCT04961866
- Acronym / sponsor ID
- 308:10/2019
- Conditions
- Hand Muscle Strain
- Keywords
- protein, parenteral, critical ill patient, ICU
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 14 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.
Sixty patients who need Parenteral nutrition for more than 48h will be assigned into two groups .Group A (n=30) patient will receive 1g/kg/day protein and group B n=30) patient will receive 2g /kg/day. In both groups caloric requirement will be fixed at 25- 30 kcal /kg/d.
Detailed description
In this study after obtaining approval from our hospital ethics committee, a written informed consent will be obtained from patient's next of kin.
Sixty patients who need PN for more than 48h will be assigned into two groups .Group A (n=30) patient will receive 1g/kg/day protein and group B n=30) patient will receive 2g /kg/day. In both groups caloric requirement will be fixed at 25- 30 kcal /kg/d.
Inclusion criteria:
Age: from 18 to 60 years Sex : male or female Predicted to be in icu ≥ 48 hs Predicted to have PN for> 48 hs.
Exclusion criteria:
Pregnant female Hepatic patients Renal patients Age <18 years
Technique of the study :
60 abdominal surgery/trauma ICU patients who have a contraindication or intolerance to enteral nutrition(EN),will be fed parenterally within 24-48 h from admission and divided according to the protein delivery into two groups.
Group A , those patients will receive parenteral proteins in a dose of 1 g/kg/day.
Group B, those patients will receive parenteral proteins in a dose of 2g/kg /day The nutrition will be delivered through a central line and using separate bottles technique ,because of the lack of a compounding unit and commercial bags in our hospital, After exclusion of the protein calories (will be given as 10%aa )the rest of energy requirement will be divided between carbohydrates (glucose25%)and lipids(SMOF20%) in a ratio of 60:40 Serum electrolytes, blood glucose, lipid profile and serum creatinine will be monitored and corrected regularly in every patient
The two groups will be compared as regarding the following :
hand grip strength Time of staying on Icu Time of staying in hospital Ultrasound biceps muscle thickness Nitrogen balances
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Dietary Supplement: parenteral protein 1 g/kgpatients received 1 g/ kg of protein |
| Group B | Active comparator | Dietary Supplement: Parenteral nutrition 2 g/kgpatients received 2 g/ kg of protein |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age: from 18 to 70 years Sex : male or female Predicted to be in icu ≥ 48 hs Predicted to have PN for> 48 hs.
Key exclusion criteria (1 listed)
- Hepatic patients Renal patients Age <18 years
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 |
|---|---|---|
| parenteral protein 1 g/kgpatients received 1 g/ kg of protein | Dietary supplement | Group A |
| Parenteral nutrition 2 g/kgPatients received 2 g/ kg of protein | Dietary supplement | Group B |
Primary outcome
hand grip strength
Time frame: 10 days
hand grip strength using dynamometer
2 secondary outcomes
ultrasound guided muscle thickness
Time frame: 10 days
nitrogen balances
Time frame: 10 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 10 Aug 2021.
- Individual participant dataSharing planned: No
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.
Ibrahim A. Youssif, MD study chair
Minia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing parenteral protein 1 g/kg and Parenteral nutrition 2 g/kg in people with Hand Muscle Strain, run by Minia 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 1 inclusion and 1 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 10 Aug 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?
hand grip strength (time frame: 10 days). 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 10 Aug 2021.