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NCT Number: NCT04468503

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.

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Key information

Conditions

Critical Illness Disease Attributes Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Protein

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Allama Iqbal Open University

Islamabad, Federal, 46000, Pakistan

About this study

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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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Two differnt protien prescription (ig per kg per day and 2g per kg /day )will be assigned to each group interventional

Other

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.

Primary outcomes

  1. 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.

  2. 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

Secondary outcomes

  1. Sequential Organ Failure Assessment (SOFA Score)

    Time frame: 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).

  2. protein bio markers

    Time frame: up to 72 hours in ICU stay

    Blood Urea Nitrogen, Albumin, C- reactive protien

Sponsors and collaborators

Lead sponsor

Allama Iqbal Open University Islamabad

Other

Collaborators

  • Shifa International Hospital

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jul 13, 2020
Registry last updated
Jun 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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