<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04468503</url>
  </required_header>
  <id_info>
    <org_study_id>HEC acadmic research</org_study_id>
    <nct_id>NCT04468503</nct_id>
  </id_info>
  <brief_title>Comparative Effect of Protein Prescription Strategies on Nitrogen Balance and Upshots in Critically Ill Patients</brief_title>
  <official_title>Comparative Effect of Protein Prescription Strategies on Nitrogen Balance and Upshots in Critically Ill Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Allama Iqbal Open University Islamabad</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Shifa International Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Allama Iqbal Open University Islamabad</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is Interventional clinical trail will be conducted in Internationale hospital ICU s&#xD;
      patients with higher nutrition risk. two doses of protein 1 g/kg/day Vs 2 g/ kg day will be&#xD;
      given and its outcome will be checked on nitrogen balance , clinical outcome length of&#xD;
      hospital stay, mortality ratio and re admission within 30 days.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      STUDY DESIGN This is the prospective interventional randomized controlled trial in which&#xD;
      effect of protein prescription on UUN and clinical outcome of critically ill patients enroll&#xD;
      in the study will compare The NUTRIC scores will be calculated manually, based on data from&#xD;
      the medical records of critically ill patients.This trail will be conducted in three stages.&#xD;
&#xD;
      In Phase I all admitted patients in critical care unit will be screen by. APACHE II NUTRIC&#xD;
      Score Phase II: Patients with nutrition risk will randomly divided into two group (1:1)&#xD;
      Interventional Group None Interventional Group Phase III: Follow the patient for 28 days&#xD;
      after discharge from Hospital. Study Locale The study will be conducted in the ICUs (SICUs,&#xD;
      MICUs, HDU) of Hospital in Islamabad, for this study organizational approval from formal&#xD;
      ethical committee will be taken during the time period of six months.&#xD;
&#xD;
      STATISTICAL METHODS:&#xD;
&#xD;
      Descriptive statistics will be use for demographic data and over all outcomes, further more&#xD;
      analytical stat will be used to the type of variables and objective of the study. Z test will&#xD;
      be use for the comparison of quantitative variables and Chi square test will be use for&#xD;
      categorical data. A NOVA will be use where applicable&#xD;
&#xD;
      .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 1, 2020</start_date>
  <completion_date type="Anticipated">September 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in nitrogen balance</measure>
    <time_frame>for base line is within 24hours og randomization,for nitrogen balence reassessment every 72 hourly</time_frame>
    <description>change in nitrogen balance from baseline.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Readmission in hospital within 30 days of discharge.</measure>
    <time_frame>30 days after discharg</time_frame>
    <description>Patient will be followed for 30 days after discharge from hospital for monitoring, e.g. readmission in hospital Mortality ratio</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>SOFA Score,</measure>
    <time_frame>72hrly till ICU saty</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>protein bio markers</measure>
    <time_frame>72hrly till ICU saty</time_frame>
    <description>Blood Urea Nitrogen, Albumin, C- reactive protien</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Critical Illness</condition>
  <condition>Malnutrition; Protein</condition>
  <arm_group>
    <arm_group_label>1 g per kg body weight per day</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <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.&#xD;
Base line characters(BMI, nitrogen Balance, Protein biomarker, LFTs, RFTs, GCS)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2 g per kg body weight per day</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <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.&#xD;
Base line characters(BMI, nitrogen Balance, Protein bio marker, LFTs. , RFTs, GCS)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Two differnt protien prescription (ig per kg per day and 2g per kg /day )will be assigned to each group interventional</intervention_name>
    <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.</description>
    <arm_group_label>1 g per kg body weight per day</arm_group_label>
    <arm_group_label>2 g per kg body weight per day</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Critically ill patient with nutritional risk Age &gt;18 years Pt. ICU stay&gt; 48hrs&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients on ventilator &gt; 72 h &lt; 48 hrs.' stay in ICU Withdrawal of life support within 7&#xD;
        days of randomization&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dr. Mahpara Safdar, phd</last_name>
    <role>Study Chair</role>
    <affiliation>Allama Iqbal Open University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>zainab bibi, M.phill</last_name>
    <phone>03349103415</phone>
    <email>bibi_zainab@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Dr.Rezzan Khan, phd</last_name>
    <phone>03455267371</phone>
    <email>rezzankhan@hotmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Allama Iqbal Open University</name>
      <address>
        <city>Islamabad</city>
        <state>Federal</state>
        <zip>46000</zip>
        <country>Pakistan</country>
      </address>
    </facility>
    <contact>
      <last_name>Zainab Bibi, M.phill</last_name>
      <phone>03349103415</phone>
      <email>bibi_zainab@yahoo.com</email>
    </contact>
    <contact_backup>
      <last_name>Mahparah Safdar, Phd</last_name>
      <phone>03005610162</phone>
      <email>mahpara.jadoon@aiou.edu.pk</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Pakistan</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 3, 2020</study_first_submitted>
  <study_first_submitted_qc>July 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 13, 2020</study_first_posted>
  <last_update_submitted>July 8, 2020</last_update_submitted>
  <last_update_submitted_qc>July 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Allama Iqbal Open University Islamabad</investigator_affiliation>
    <investigator_full_name>Zainab Bibi</investigator_full_name>
    <investigator_title>Zainab Bibi. Phd Scholar</investigator_title>
  </responsible_party>
  <keyword>critical illness, protien, malnutrition</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Malnutrition</mesh_term>
    <mesh_term>Kwashiorkor</mesh_term>
    <mesh_term>Critical Illness</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>basic detail</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04468503
org study id: HEC acadmic research
nct id: NCT04468503
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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

      .
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Change in nitrogen balance
time frame: for base line is within 24hours og randomization,for nitrogen balence reassessment every 72 hourly
description: change in nitrogen balance from baseline.
measure: Readmission in hospital within 30 days of discharge.
time frame: 30 days after discharg
description: Patient will be followed for 30 days after discharge from hospital for monitoring, e.g. readmission in hospital Mortality ratio
measure: SOFA Score,
time frame: 72hrly till ICU saty
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.
measure: protein bio markers
time frame: 72hrly till ICU saty
description: Blood Urea Nitrogen, Albumin, C- reactive protien
arm group label: 1 g per kg body weight per day
arm group type: Active Comparator
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 group label: 2 g per kg body weight per day
arm group type: Active Comparator
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: Two differnt protien prescription (ig per kg per day and 2g per kg /day )will be assigned to each group interventional
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.
arm group label: 1 g per kg body weight per day
arm group label: 2 g per kg body weight per day
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Dr. Mahpara Safdar, phd
role: Study Chair
affiliation: Allama Iqbal Open University
last name: zainab bibi, M.phill
phone: 03349103415
email: bibi_zainab@yahoo.com
last name: Dr.Rezzan Khan, phd
phone: 03455267371
email: rezzankhan@hotmail.com
facility: 
contact: 
contact backup: 
country: Pakistan
responsible party type: Principal Investigator
investigator affiliation: Allama Iqbal Open University Islamabad
investigator full name: Zainab Bibi
investigator title: Zainab Bibi. Phd Scholar
mesh term: Malnutrition
mesh term: Kwashiorkor
mesh term: Critical Illness
sharing ipd: No
ipd description: basic detail