Critical Illness, Malnutrition, Protein
Conditions
Keywords
critical illness, protein, malnutrition
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 .
Interventions
OTHERTwo differnt protien prescription (ig per kg per day and 2g per kg /day )will be assigned to each group interventional
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.
Sponsors
Shifa International Hospital
Allama Iqbal Open University Islamabad
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Urine Urea Nitrogen (UUN) for Nitrogen Balanace (NB) | 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. | 30 days after discharge | Patient will be followed for 30 days after discharge from hospital for monitoring, e.g. readmission in hospital Mortality ratio |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sequential Organ Failure Assessment (SOFA Score) | up to 72 hours in ICU stay | 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). |
| protein bio markers | up to 72 hours in ICU stay | Blood Urea Nitrogen, Albumin, C- reactive protien |
Countries
Pakistan
Outcome results
None listed