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

NCT ID: NCT04468503

Last Updated: 2024-06-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2022-09-30

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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Conditions

Critical Illness; Malnutrition; Protein

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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)

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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.

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)

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shifa International Hospital

OTHER

Sponsor Role: collaborator

Allama Iqbal Open University Islamabad

OTHER

Sponsor Role: lead

Responsible Party

Zainab Bibi

Prinicipal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dr. Mahpara Safdar, phd

Role: STUDY_CHAIR

Allama Iqbal Open University

Locations

Allama Iqbal Open University

Islamabad, Federal, Pakistan

Countries

Pakistan

References

Bibi Z, Safdar M, Hadayat A. Comparative effect of protein dosage on nitrogen balance and health outcomes in critically ill patients. J Pak Med Assoc. 2025 May;75(5):699-703. doi: 10.47391/JPMA.20753.

Reference Type: DERIVED

PMID: 40500809 (View on PubMed)

Other Identifiers

HEC acadmic research

Identifier Type: -

Identifier Source: org_study_id