Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Replacing Protein Via Enteral Nutrition in Critically Ill Patients (REPLENISH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04475666
Recruitment Status : Not yet recruiting
First Posted : July 17, 2020
Last Update Posted : September 2, 2020
Sponsor:
Information provided by (Responsible Party):
King Abdullah International Medical Research Center

Brief Summary:
The investigator will investigate the effect of supplemental enteral protein (1.2 g/kg/day) added to standard formula to achieve high amount of enteral protein (range 2-2.4 g/kg/day) given from ICU day 5 until ICU discharge up to ICU day 90 as compared to no supplemental enteral protein to achieve moderate amount enteral protein (0.8-1.2 g/kg/day), given in conjunction with similar amounts of stepwise caloric administration in the two groups on all-cause 90-day mortality.

Condition or disease Intervention/treatment Phase
Critical Illness Nutrition Disorders Other: Replenish protein group Other: Standard protein group Not Applicable

Detailed Description:

The REPLENISH is a multicentric, international, open label, randomized controlled trial which will enroll subjects in intensive care unit. Patients will be randomized on day 4 of ICU admission. Until ICU day 4, protein requirement will be provided according to the local practice as long as no intravenous amino acids are given and the average protein intake in the first 4 days does not exceed 0.8 g/kg/day. On ICU day 4, patients will be randomized to one of the two treatment groups: one with standard prescription without supplemental proteins (maximum1.2 g/kg/day) from the primary polymeric formula and another group will receive the standard amount of proteins (maximum 1.2 g/kg/day) from the primary polymeric formula AND supplemental protein at 1.2 g/kg/day.

Randomization will be stratified by suspected COVID-19 and then by site and the use of renal replacement therapy at the time of randomization (intermittent hemodialysis or continuous renal replacement therapy.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2502 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Replacing Protein Via Enteral Nutrition in a Stepwise Approach in Critically Ill Patients: An International, Multicenter Randomized Controlled Trial
Estimated Study Start Date : September 10, 2020
Estimated Primary Completion Date : June 15, 2022
Estimated Study Completion Date : December 15, 2022

Arm Intervention/treatment
Active Comparator: Replenish protein group
The subjects randomized to this group will receive the standard amount of proteins (maximum 1.2 g/kg/day) from the primary polymeric formula AND supplemental protein at 1.2 g/kg/day
Other: Replenish protein group
For patients with Body mass index(BMI) <30, use pre-ICU actual body weight(BW) for the calculation; if unavailable, use weight on ICU admission. For patients with BMI >=30, use adjusted body weight

Active Comparator: Standard protein group
The subjects randomized to this group will receive standard prescription without supplemental proteins (maximum1.2 g/kg/day) from the primary polymeric formula. No supplemental protein will be allowed
Other: Standard protein group
For patients with BMI <30, use pre-ICU actual BW for the calculation; if unavailable, use weight on ICU admission. For patients with BMI >=30, use adjusted body weight




Primary Outcome Measures :
  1. 90 day-all cause mortality [ Time Frame: 90 days ]
    Mortality 90 days post randomization


Secondary Outcome Measures :
  1. Days alive at day 90 without life support [ Time Frame: 90 days ]
    use of vasopressor/inotropic support, invasive mechanical ventilation and/or renal replacement therapy

  2. Days alive and out of hospital at day 90 [ Time Frame: 90 days ]
    90 day survival after randomization

  3. Bacteremia until 2 days of ICU stay [ Time Frame: until 2 days post ICU. ]
    Any symptoms of bacteremia

  4. New or progression of Skin Pressure Ulcers [ Time Frame: ICU stay ]
    anytime during ICU stay

  5. Functional assessment at day 90 [ Time Frame: Day 90 ]
    SARC-F screen for sarcopenia and EuroQoL


Other Outcome Measures:
  1. Safety outcomes during ICU stay [ Time Frame: ICU stay ]
    New episode of stage 2 or higher AKI by KDIGO criteria; 2. Pneumonia defined as episodes of newly confirmed pneumonia according to the modified CDC criteria; 3. Grade IV Acute Gastrointestinal injury (AGI)

  2. Minor safety outcomes during ICU stay [ Time Frame: ICU stay ]
    Feeding tolerance; Diarrhoea; Refeeding syndrome



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria(on ICU calendar day 4 or the morning of day 5)

  1. Age ≥18-years old
  2. Patient started on enteral nutrition (EN) via nasogastric/orogastric or duodenal or percutaneous endoscopic gastrostomy (PEG) or jejunostomy tubes.
  3. The patient is on invasive mechanical ventilation and unlikely to be discharged from ICU next day.

Exclusion Criteria:

  1. Lack of commitment to full life support or brain death. Patients with "Do Not Resuscitate" order but with commitment to ongoing life support can be enrolled.
  2. Patients on any amount of parenteral nutrition (PN) in ICU at the time of screening, whether PN is used alone or in combination with enteral nutrition. Non-nutritional calories (dextrose, propofol, citrate) not considered as PN.
  3. Patients who received an average protein of more than 0.8g/kg/day in the first 4 ICU days.
  4. Patients being fed entirely through oral route - i.e. those who are eating.
  5. Pregnancy.
  6. Burn patients.
  7. Prisoners or those undergoing forced treatment.
  8. Patients with hepatic encephalopathy or Child C liver cirrhosis
  9. Inherited defect of amino acid metabolism.
  10. Allergies to protein supplement

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04475666


Contacts
Layout table for location contacts
Contact: Yaseen M Arabi, MD 0118011111 ext 18855 arabi@ngha.med.sa
Contact: Musharaf Sadat, MBBS 0118011111 ext 10822 sadatmu@ngha.med.sa

Sponsors and Collaborators
King Abdullah International Medical Research Center
Investigators
Layout table for investigator information
Principal Investigator: Yaseen M Arabi, MD King Saud Bin Abdulaziz University for Health Sciences
Publications of Results:
Other Publications:

Layout table for additonal information
Responsible Party: King Abdullah International Medical Research Center
ClinicalTrials.gov Identifier: NCT04475666    
Other Study ID Numbers: RC19/414/R
First Posted: July 17, 2020    Key Record Dates
Last Update Posted: September 2, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Nutrition Disorders
Critical Illness
Disease Attributes
Pathologic Processes