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

NCT04468503 | Completed

• 1 other identifier: HEC acadmic research
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Illness; Malnutrition; Protein

Keywords

critical illness; protein; malnutrition

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Sequential Organ Failure Assessment (SOFA Score)

  up to 72 hours in ICU stay

• protein bio markers

  up to 72 hours in ICU stay

Study Arms (2)

1 g per kg body weight per day

ACTIVE COMPARATOR

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

2 g per kg body weight per day

ACTIVE COMPARATOR

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

Interventions

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.

1 g per kg body weight per day; 2 g per kg body weight per day

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Critically ill patient with nutritional risk Age \>18 years Pt. ICU stay\> 48hours

You may not qualify if:

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

Sponsors & Collaborators

• Allama Iqbal Open University Islamabad: lead
• Shifa International Hospital: collaborator

Study Sites (1)

Allama Iqbal Open University

Islamabad, Federal, 46000, Pakistan

Location

Related Publications (1)

• 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.

  PMID: 40500809 DERIVED

MeSH Terms

Conditions

Critical Illness; Malnutrition

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Dr. Mahpara Safdar, phd

  Allama Iqbal Open University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicipal Investigator

Study Record Dates

• First Submitted: July 3, 2020
• First Posted: July 13, 2020
• Study Start: September 1, 2020
• Primary Completion: June 30, 2022
• Study Completion: September 30, 2022
• Last Updated: June 11, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)