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

Primary Purpose

Critical Illness, Malnutrition; Protein

Status
Unknown status
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Two differnt protien prescription (ig per kg per day and 2g per kg /day )will be assigned to each group interventional
Sponsored by
Allama Iqbal Open University Islamabad
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Critical Illness focused on measuring critical illness, protien, malnutrition

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Allama Iqbal Open University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1 g per kg body weight per day

2 g per kg body weight per day

Arm Description

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)

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)

Outcomes

Primary Outcome Measures

Change in nitrogen balance
change in nitrogen balance from baseline.
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

Secondary Outcome Measures

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.
protein bio markers
Blood Urea Nitrogen, Albumin, C- reactive protien

Full Information

First Posted
July 3, 2020
Last Updated
July 8, 2020
Sponsor
Allama Iqbal Open University Islamabad
Collaborators
Shifa International Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04468503
Brief Title
Comparative Effect of Protein Prescription Strategies on Nitrogen Balance and Upshots in Critically Ill Patients
Official Title
Comparative Effect of Protein Prescription Strategies on Nitrogen Balance and Upshots in Critically Ill Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2020 (Anticipated)
Primary Completion Date
June 30, 2021 (Anticipated)
Study Completion Date
September 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Allama Iqbal Open University Islamabad
Collaborators
Shifa International Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness, Malnutrition; Protein
Keywords
critical illness, protien, malnutrition

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1 g per kg body weight per day
Arm Type
Active Comparator
Arm Description
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)
Arm Title
2 g per kg body weight per day
Arm Type
Active Comparator
Arm Description
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)
Intervention Type
Other
Intervention Name(s)
Two differnt protien prescription (ig per kg per day and 2g per kg /day )will be assigned to each group interventional
Intervention Description
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 Outcome Measure Information:
Title
Change in nitrogen balance
Description
change in nitrogen balance from baseline.
Time Frame
for base line is within 24hours og randomization,for nitrogen balence reassessment every 72 hourly
Title
Readmission in hospital within 30 days of discharge.
Description
Patient will be followed for 30 days after discharge from hospital for monitoring, e.g. readmission in hospital Mortality ratio
Time Frame
30 days after discharg
Secondary Outcome Measure Information:
Title
SOFA Score,
Description
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.
Time Frame
72hrly till ICU saty
Title
protein bio markers
Description
Blood Urea Nitrogen, Albumin, C- reactive protien
Time Frame
72hrly till ICU saty

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
zainab bibi, M.phill
Phone
03349103415
Email
bibi_zainab@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Dr.Rezzan Khan, phd
Phone
03455267371
Email
rezzankhan@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Mahpara Safdar, phd
Organizational Affiliation
Allama Iqbal Open University
Official's Role
Study Chair
Facility Information:
Facility Name
Allama Iqbal Open University
City
Islamabad
State/Province
Federal
ZIP/Postal Code
46000
Country
Pakistan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zainab Bibi, M.phill
Phone
03349103415
Email
bibi_zainab@yahoo.com
First Name & Middle Initial & Last Name & Degree
Mahparah Safdar, Phd
Phone
03005610162
Email
mahpara.jadoon@aiou.edu.pk

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
basic detail

Learn more about this trial

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

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