Replacing Protein Via Enteral Nutrition in a Stepwise Approach in Critically Ill Patients (Replenish)

December 30, 2020 updated by: King Abdullah International Medical Research Center

Replacing Protein Via Enteral Nutrition in a Stepwise Approach in Critically Ill Patients: Feasibility Randomized Controlled Trial

In this study, we will explore the feasibility of a randomized controlled trial that will compare high protein dose from ICU day 6 to 14 with moderate protein intake.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients will be recruited on day 1-2 of ICU admission. On day 5, patients will be randomized into one of the two intervention arms;

Replenish Protein group:

Patients randomized to this group will receive 2 g of protein/kg/day (acceptable range 1.8 - 2.2 g of protein/kg/day) for day 6-14.

Standard Protein group:

Patients randomized to this group will receive protein at 0.8 - 1.0 g of protein/kg/day for day 6-14

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Saudi Arabia
      • Jeddah, Saudi Arabia, 21423
        • King Abdulaziz Medical City
      • Riyadh, Saudi Arabia, 11426
        • King Abdulaziz Medical City

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria

  1. Age ≥ 18 years
  2. Mechanically ventilated
  3. Receiving enteral feeding via nasogastric/orogastric or duodenal or PEG or jejunostomy tubes and
  4. Expected to stay ≥ 1 week in the ICU

Exclusion criteria

  1. Lack of commitment to ongoing life support, which includes;

    • Terminal Illness (Malignancy or irreversible condition with 6 month mortality > 50%)
    • DNR order in the first 48 hours and brain death within 48 hours of admission) (Don't include the presence of a "Do Not Resuscitate" order alone, if there is a commitment to ongoing life support).
  2. Patients not fed within 48 hours of admission
  3. Patients on total parenteral nutrition (TPN)
  4. Patients being fed orally
  5. Chronic renal failure
  6. Chronic liver disease
  7. Renal replacement therapy
  8. Pregnancy.
  9. Kidney transplant
  10. Post-liver transplant.
  11. Post cardiac arrest.
  12. Burn patients.
  13. Prisoners

Screened patients will be screened again for eligibility at day 5, should be mechanically ventilated and expected to stay ≥ 3 days in the ICU. At this point, patients will be excluded if they meet the following;

  1. New onset renal replacement therapy.
  2. Acute Kidney Injury (serum creatinine > 3 times the preacute level or serum creatinine >350mmol/L with a recent increase of >44 mmols/L)
  3. Significant liver impairment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Replenish Protein group
Subjects randomized to this group will receive 2 g of protein/kg/day (acceptable range as 1.8 - 2.2 g of protein/kg/day) for day 6-14.
Dietary supplement: Replenish Protein
Subjects randomized to this group will receive 2 g of protein/kg/day (acceptable range as 1.8 - 2.2 g of protein/kg/day) for day 6-14.
Other Names:
  • Intervention group
OTHER: Standard Protein group
Subjects randomized to this group will receive 0.8 - 1 g of protein/kg/day for day 6-14
Dietary supplement: Standard protein
Subjects randomized to this group will receive 0.8 - 1 g of protein/kg/day for day 6-14
Other Names:
  • Control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recruitment
Time Frame: 6 months
Recruitment log
6 months
Retention rate
Time Frame: 14 days
withdrawals
14 days
Achieved protein intake
Time Frame: 14 days
Feeding data
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King Abdullah International Medical Research Center

Investigators

  • Principal Investigator: Yaseen M Arabi, MD, King Abdulaziz Medical City-Ministry of national guard

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 16, 2018

Primary Completion (ACTUAL)

May 10, 2019

Study Completion (ACTUAL)

September 10, 2019

Study Registration Dates

First Submitted

February 22, 2018

First Submitted That Met QC Criteria

March 21, 2018

First Posted (ACTUAL)

March 29, 2018

Study Record Updates

Last Update Posted (ACTUAL)

January 5, 2021

Last Update Submitted That Met QC Criteria

December 30, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC17/252/R

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data will be shared with the other participating sites after the completion of the main study and upon the descretion of the study Principle investigator only

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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