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

Critical Illness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04468503
• Other study ID #: HEC acadmic research
• Status: Completed
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: September 30, 2022

Study information

• Verified date: June 2024
• Source: Allama Iqbal Open University Islamabad
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 within 30 days.

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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Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Malnutrition
• Protein

Intervention

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.

Locations

Country	Name	City	State
Pakistan	Allama Iqbal Open University	Islamabad	Federal

Sponsors (2)

Lead Sponsor	Collaborator
Allama Iqbal Open University Islamabad	Shifa International Hospital

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urine Urea Nitrogen (UUN) for Nitrogen Balanace (NB)	change in nitrogen balance from baseline.	for base line is within 24hours of randomization,for nitrogen balence reassessment every 72 hourly
Primary	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 discharge
Secondary	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).	up to 72 hours in ICU stay
Secondary	protein bio markers	Blood Urea Nitrogen, Albumin, C- reactive protien	up to 72 hours in ICU stay