Critical IllnessNCT04468503
Comparative Effect of Protein Prescription Strategies on Nitrogen Balance and Upshots in Critically Ill Patients
A study testing Two differnt protien prescription (ig per kg per day and 2g per kg /day )will be assigned to each group interventional in people with Critical Illness and Malnutrition, run by Allama Iqbal Open University Islamabad at 1 site in Pakistan.
Trial summary
This is Interventional clinical trail will be conducted in Internationale hospital ICU s patients with higher nutrition risk. two doses of protein 1 g/kg/day Vs 2 g/ kg day will be given and its outcome will be checked on nitrogen balance , clinical outcome length of hospital stay, mortality ratio and re admission… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Malnutrition, Protein
- What is being tested?
- Two differnt protien prescription (ig per kg per day and 2g per kg /day )will be assigned to each group interventional
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Sep 2020to 30 Sep 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Critically ill patient with nutritional risk Age >18 years Pt. ICU stay> 48hours
Who cannot join
- Patients on ventilator > 72 hours < 48 hours.' stay in ICU Withdrawal of life support within 7 days of randomization
Trial locations and contacts
1 site in 1 country.
About this study
This is Interventional clinical trail will be conducted in Internationale hospital ICU s patients with higher nutrition risk. two doses of protein 1 g/kg/day Vs 2 g/ kg day will be given and its outcome will be checked on nitrogen balance , clinical outcome length of hospital stay, mortality ratio and re admission within 30 days.
Read the detailed description
STUDY DESIGN This is the prospective interventional randomized controlled trial in which effect of protein prescription on UUN and clinical outcome of critically ill patients enroll in the study will compare The NUTRIC scores will be calculated manually, based on data from the medical records of critically ill patients.This trail will be conducted in three stages.
In Phase I all admitted patients in critical care unit will be screen by. APACHE II NUTRIC Score Phase II: Patients with nutrition risk will randomly divided into two group (1:1) Interventional Group None Interventional Group Phase III: Follow the patient for 28 days after discharge from Hospital. Study Locale The study will be conducted in the ICUs (SICUs, MICUs, HDU) of Hospital in Islamabad, for this study organizational approval from formal ethical committee will be taken during the time period of six months.
STATISTICAL METHODS:
Descriptive statistics will be use for demographic data and over all outcomes, further more analytical stat will be used to the type of variables and objective of the study. Z test will be use for the comparison of quantitative variables and Chi square test will be use for categorical data. A NOVA will be use where applicable
.
- Conditions
- Critical Illness, Malnutrition, Protein
- Being tested
- Two differnt protien prescription (ig per kg per day and 2g per kg /day )will be assigned to each group interventional
- Keywords
- critical illness, protein, malnutrition
- Medical subject headings
- Critical Illness, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Two differnt protien prescription (ig per kg per day and 2g per kg /day )will be assigned to each group interventionalOther
In this study intervention will be the dose of protein, one group will be prescribed with the protein dose (1 g/kg/day) and other group will be on prescribed higher dose (2gm/kg/day) of protein according to the ASPEN guideline for critically ill and the energy requirements (other than proteins) will be 25 kcal/kg of adjusted body weight (Picolo et al.,). Each subject in the trail will provide remaining medical nutrition therapy according to the therapeutic guidelines in the field. The medical nutrition management other than protein will be adjust according to need of each patient.
| Study group | Role | What they receive |
|---|---|---|
| 1 g per kg body weight per day | Active comparator | Protein will be receive by patients that is 1g per kg per day, Patients will be assess and according to patient actual dry weight 1 g per kg of that weight protein will provided, energy will be provided according to ASPEN guideline 2016.
Base line characters(BMI, nitrogen Balance, Protein biomarker, LFTs, RFTs, GCS) Receives: Other: Two differnt protien prescription (ig per kg per day and 2g per kg /day )will be assigned to each group interventional |
| 2 g per kg body weight per day | Active comparator | Protein will be receive by patients that is 2g per kg per day, Patients will be assess and according to patient actual dry weight 1 g per kg of that weight protein will provided, energy will be provided according to ASPEN guideline 2016.
Base line characters(BMI, nitrogen Balance, Protein bio marker, LFTs. , RFTs, GCS) Receives: Other: Two differnt protien prescription (ig per kg per day and 2g per kg /day )will be assigned to each group interventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urine Urea Nitrogen (UUN) for Nitrogen Balanace (NB)
change in nitrogen balance from baseline.
Measured: for base line is within 24hours of randomization,for nitrogen balence reassessment every 72 hourly
Readmission in hospital within 30 days of discharge.
Patient will be followed for 30 days after discharge from hospital for monitoring, e.g. readmission in hospital Mortality ratio
Measured: 30 days after discharge
Secondary outcomes (2)
Sequential Organ Failure Assessment (SOFA Score)
this tool will be use to track a person's status during the stay in an critical care unit (ICU) to determine the extent of a person's organ function or rate of failure, with a minimum SOFA score of 0 (most survival) and a maximum SOFA score of 24(risk of survival).
Measured: up to 72 hours in ICU stay
protein bio markers
Blood Urea Nitrogen, Albumin, C- reactive protien
Measured: up to 72 hours in ICU stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2020
- Study start1 Sep 2020
- Primary completion30 Jun 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allama Iqbal Open University Islamabad
- Sponsor type
- University, hospital or other
- Collaborators
- Shifa International Hospital
- Responsible party
- Principal investigator, Zainab Bibi, Allama Iqbal Open University Islamabad
- Investigators
- Dr. Mahpara Safdar, phd, Study chair, Allama Iqbal Open University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04468503
- Sponsor's protocol ID
- HEC acadmic research
- Status last verified
- Jun 2024
- First submitted
- 3 Jul 2020
- Last updated
- 11 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: basic detail
Publications
Bibi Z, Safdar M, Hadayat A. Comparative effect of protein dosage on nitrogen balance and health outcomes in critically ill patients. J Pak Med Assoc. 2025 May;75(5):699-703. doi: 10.47391/JPMA.20753.
PubMed 40500809
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effect of Protein Prescription Strategies on Nitrogen Balance and Upshots in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT04468503
- Acronym / sponsor ID
- HEC acadmic research
- Conditions
- Critical Illness, Malnutrition, Protein
- Keywords
- critical illness, protein, malnutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Allama Iqbal Open University IslamabadUniversity, hospital or other
- Collaborators
- Shifa International Hospital
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 13 Jul 2020 (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 is Interventional clinical trail will be conducted in Internationale hospital ICU s patients with higher nutrition risk. two doses of protein 1 g/kg/day Vs 2 g/ kg day will be given and its outcome will be checked on nitrogen balance , clinical outcome length of hospital stay, mortality ratio and re admission within 30 days.
Detailed description
STUDY DESIGN This is the prospective interventional randomized controlled trial in which effect of protein prescription on UUN and clinical outcome of critically ill patients enroll in the study will compare The NUTRIC scores will be calculated manually, based on data from the medical records of critically ill patients.This trail will be conducted in three stages.
In Phase I all admitted patients in critical care unit will be screen by. APACHE II NUTRIC Score Phase II: Patients with nutrition risk will randomly divided into two group (1:1) Interventional Group None Interventional Group Phase III: Follow the patient for 28 days after discharge from Hospital. Study Locale The study will be conducted in the ICUs (SICUs, MICUs, HDU) of Hospital in Islamabad, for this study organizational approval from formal ethical committee will be taken during the time period of six months.
STATISTICAL METHODS:
Descriptive statistics will be use for demographic data and over all outcomes, further more analytical stat will be used to the type of variables and objective of the study. Z test will be use for the comparison of quantitative variables and Chi square test will be use for categorical data. A NOVA will be use where applicable
.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 g per kg body weight per day | Active comparator | Other: Two differnt protien prescription (ig per kg per day and 2g per kg /day )will be assigned to each group interventionalProtein will be receive by patients that is 1g per kg per day, Patients will be assess and according to patient actual dry weight 1 g per kg of that weight protein will provided, energy will be provided according to ASPEN guideline 2016. Base line characters(BMI, nitrogen Balance, Protein biomarker, LFTs, RFTs, GCS) |
| 2 g per kg body weight per day | Active comparator | Other: Two differnt protien prescription (ig per kg per day and 2g per kg /day )will be assigned to each group interventionalProtein will be receive by patients that is 2g per kg per day, Patients will be assess and according to patient actual dry weight 1 g per kg of that weight protein will provided, energy will be provided according to ASPEN guideline 2016. Base line characters(BMI, nitrogen Balance, Protein bio marker, LFTs. , RFTs, GCS) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Critically ill patient with nutritional risk Age >18 years Pt. ICU stay> 48hours
Key exclusion criteria (1 listed)
- Patients on ventilator > 72 hours < 48 hours.' stay in ICU Withdrawal of life support within 7 days of randomization
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 |
|---|---|---|
| Two differnt protien prescription (ig per kg per day and 2g per kg /day )will be assigned to each group interventionalIn this study intervention will be the dose of protein, one group will be prescribed with the protein dose (1 g/kg/day) and other group will be on prescribed higher dose (2gm/kg/day) of protein according to the ASPEN guideline for critically ill and the energy requirements (other than proteins) will be 25 kcal/kg of adjusted body weight (Picolo et al.,). Each subject in the trail will provide remaining medical nutrition therapy according to the therapeutic guidelines in the field. The medical nutrition management other than protein will be adjust according to need of each patient. | Other | 1 g per kg body weight per day, 2 g per kg body weight per day |
Primary outcome
Urine Urea Nitrogen (UUN) for Nitrogen Balanace (NB)
Time frame: for base line is within 24hours of randomization,for nitrogen balence reassessment every 72 hourly
change in nitrogen balance from baseline.
Readmission in hospital within 30 days of discharge.
Time frame: 30 days after discharge
Patient will be followed for 30 days after discharge from hospital for monitoring, e.g. readmission in hospital Mortality ratio
2 secondary outcomes
Sequential Organ Failure Assessment (SOFA Score)
Time frame: up to 72 hours in ICU stay
protein bio markers
Time frame: up to 72 hours in ICU stay
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 11 Jun 2024.
- Derived from this study: PubMed 40500809Bibi Z, Safdar M, Hadayat A. Comparative effect of protein dosage on nitrogen balance and health outcomes in critically ill patients. J Pak Med Assoc. 2025 May;75(5):699-703. doi: 10.47391/JPMA.20753.
- Individual participant dataSharing planned: No. basic detail
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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.
Dr. Mahpara Safdar, phd study chair
Allama Iqbal Open 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 Two differnt protien prescription (ig per kg per day and 2g per kg /day )will be assigned to each group interventional in people with Critical Illness and Malnutrition, run by Allama Iqbal Open University Islamabad at 1 site in Pakistan.
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 11 Jun 2024. 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 Pakistan. 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?
Urine Urea Nitrogen (UUN) for Nitrogen Balanace (NB) (time frame: for base line is within 24hours of randomization,for nitrogen balence reassessment every 72 hourly). 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?
On the ClinicalTrials.gov record for NCT04468503, which also lists 1 linked publication.
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 11 Jun 2024.