Replacing Protein Via Enteral Nutrition in Critically Ill Patients

NCT ID: NCT04475666

Last Updated: 2025-09-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 2502 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-21
• Study Completion Date: 2026-04-30

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.

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.

Conditions

Critical Illness; Nutrition Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Replenish protein group

Intervention Type: OTHER

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

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

Group Type: ACTIVE_COMPARATOR

Standard protein group

Intervention Type: OTHER

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

Interventions

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

Intervention Type: 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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

King Abdullah International Medical Research Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yaseen M Arabi, MD

Role: PRINCIPAL_INVESTIGATOR

King Saud Bin Abdulaziz University for Health Sciences

Locations

King Abdulaziz Medical city

Jeddah, Jeddah, Saudi Arabia

Site Status: RECRUITING

Intensive Care Unit, King Abdulaziz Medical City

Riyadh, , Saudi Arabia

Site Status: RECRUITING

Countries

Saudi Arabia

Central Contacts

Yaseen M Arabi, MD

Role: CONTACT

arabi@ngha.med.sa

0118011111 ext. 18855

Musharaf Sadat, MBBS

Role: CONTACT

sadatmu@ngha.med.sa

0118011111 ext. 10822

Facility Contacts

Fahad M Al-Hameed, MD

Role: primary

HameedF@ngha.med.sa

00966 12 2266666 ext. 22771

Ohoud Al Orabi, MMedSC

Role: backup

alorabioh@NGHA.MED.SA

0096612 2266666 ext. 28864

References

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Other Identifiers

RC19/414/R

Identifier Type: -

Identifier Source: org_study_id