Clinical trial NCT04468503: Comparative Effect of Protein Prescription Strategies on Nitrogen Balance and Upshots in Critically Ill Patients
Official title: Comparative Effect of Protein Prescription Strategies on Nitrogen Balance and Upshots in Critically Ill Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Illness
Malnutrition
Protein
Keywords: critical illness
protein
malnutrition
Lead sponsor: Allama Iqbal Open University Islamabad
Sponsor class: OTHER
Collaborators: name: Shifa International Hospital
First posted: 2020-07-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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 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

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Eligibility criteria: Inclusion Criteria:

Critically ill patient with nutritional risk Age \>18 years Pt. ICU stay\> 48hours

Exclusion Criteria:

Patients on ventilator \> 72 hours \< 48 hours.' stay in ICU Withdrawal of life support within 7 days of randomization

Primary outcomes:
measure: Urine Urea Nitrogen (UUN) for Nitrogen Balanace (NB)
timeFrame: for base line is within 24hours of randomization,for nitrogen balence reassessment every 72 hourly
measure: Readmission in hospital within 30 days of discharge.
timeFrame: 30 days after discharge
Secondary outcomes:
measure: Sequential Organ Failure Assessment (SOFA Score)
timeFrame: up to 72 hours in ICU stay
measure: protein bio markers
timeFrame: up to 72 hours in ICU stay
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Allama Iqbal Open University
state: Federal
Study officials:
affiliation: Allama Iqbal Open University
name: Dr. Mahpara Safdar, phd
role: STUDY_CHAIR
References: