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The Effect of Higher Protein Dosing in Critically Ill Patients: A Multicenter Randomized Trial

NCT04012333 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2022-10-27

No results posted yet for this study

Summary

The primary research question: In critically ill patients with nutrition 'risk factors', what is the effect of providing combined EN/PN to the group prescribed a higher dose (≥2.2 grams/kg/day) of protein/amino acid administration compared to a low group prescribed ≤1.2 gram/kg/day (EN only) on patient's functional recovery as measured by 6-minute walk distance just prior to hospital discharge? The hypothesis: Compared to a control group reflective of usual care prescribing practices and an EN only approach, the administration of a higher dose protein/amino acids using EN and PN to nutritionally high-risk critically ill patients will be associated with improved functional outcome.

Conditions

Interventions

DRUG

OLIMEL 7,6%E / PeriOLIMEL 2,5%E

OLIMEL 7,6%E will be administered via a central access whereas PeriOLIMEL 2,5%E will be administered peripherally.

Sponsors & Collaborators

  • Clinical Evaluation Research Unit at Kingston General Hospital

    collaborator OTHER

  • RWTH Aachen University

    lead OTHER

Principal Investigators

  • Christian Stoppe, MD · University Hospital, Aachen

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-30
Primary Completion
2022-03-31
Completion
2022-03-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

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 NCT04012333 on ClinicalTrials.gov