Comparative Effect of Protein Prescription Strategies on Nitrogen Balance and Upshots in Critically Ill Patients

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.

Study Overview

• Status: Unknown
• Conditions: Critical Illness; Malnutrition; Protein
• Intervention / Treatment: Other: Two differnt protien prescription (ig per kg per day and 2g per kg /day )will be assigned to each group interventional

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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• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zainab Bibi, M.phill; Phone Number: 03349103415; Email: bibi_zainab@yahoo.com
• Study Contact Backup: Name: Dr.Rezzan Khan, phd; Phone Number: 03455267371; Email: rezzankhan@hotmail.com

Study Locations

• Pakistan
  • Federal
    • Islamabad, Federal, Pakistan, 46000
      • Allama Iqbal Open University
      • Contact: Zainab Bibi, M.phill; Phone Number: 03349103415; Email: bibi_zainab@yahoo.com
      • Contact: Mahparah Safdar, Phd; Phone Number: 03005610162; Email: mahpara.jadoon@aiou.edu.pk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1 g per kg body weight per day; 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)	Other: Two 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.
Active Comparator: 2 g per kg body weight per day; 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)	Other: Two 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in nitrogen balance	change in nitrogen balance from baseline.	for base line is within 24hours og 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	30 days after discharg

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	72hrly till ICU saty
protein bio markers	Blood Urea Nitrogen, Albumin, C- reactive protien	72hrly till ICU saty

Collaborators and Investigators

• Sponsor: Allama Iqbal Open University Islamabad
• Collaborators: Shifa International Hospital
• Investigators: Study Chair: Dr. Mahpara Safdar, phd, Allama Iqbal Open University

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2020
• Primary Completion (Anticipated): June 30, 2021
• Study Completion (Anticipated): September 30, 2021

Study Registration Dates

• First Submitted: July 3, 2020
• First Submitted That Met QC Criteria: July 8, 2020
• First Posted (Actual): July 13, 2020

Study Record Updates

• Last Update Posted (Actual): July 13, 2020
• Last Update Submitted That Met QC Criteria: July 8, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: critical illness, protien, malnutrition
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Nutrition Disorders; Severe Acute Malnutrition; Critical Illness; Malnutrition; Kwashiorkor
• Other Study ID Numbers: HEC acadmic research

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: basic detail

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No