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Replacing Protein Via Enteral Nutrition in Critically Ill Patients

NCT04475666 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2502

Last updated 2025-09-08

No results posted yet for this study

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.

Conditions

  • Critical Illness
  • Nutrition Disorders

Interventions

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

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

Sponsors & Collaborators

  • King Abdullah International Medical Research Center

    lead OTHER

Principal Investigators

  • Yaseen M Arabi, MD · King Saud Bin Abdulaziz University for Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-09-21
Primary Completion
2025-11-30
Completion
2026-04-30

Countries

  • Saudi Arabia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04475666 on ClinicalTrials.gov