Optimizing Early Nutrition Support in Severe Stroke-2

NCT05998902 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 546

Last updated 2026-03-19

No results posted yet for this study

Summary

Post stroke pneumonia (PSP) is one of the common early complications of stroke. Post-stroke infections, in general, are associated with less favorable neurologic outcomes. Aspiration is one of the most feared complications of enteral nutrition and can lead to the occurrence of pneumonia. Severe stroke patients are at high risk for aspiration due to some factors such as the reduced level of consciousness, inability to protect the airway and so on. The purpose of this study is to explore the ideal nutrition support strategy for patient with acute severe stroke to help reduce the incidence of PSP and improve the prognosis.

Conditions

Interventions

PROCEDURE

Trophic enteral feeding combined with supplemental parenteral nutrition

The caloric goal of the first day is one-third of caloric requirements, the second day is half of caloric requirements, the third day is 70-100% and sustained for 1 week. Patients will receive the trophic enteral feeding with a caloric target of 500kcal/d (20-35ml/h), and the remaining calories are supplemented by parenteral nutrition. Protein requirements are calculated at 1.2 to 1.5 g per kilogram of body weight per day.

PROCEDURE

Full enteral feeding

The caloric goal of the first day is one-third of caloric requirements, the second day is half of caloric requirements, the third day is 70-100% and sustained for 1 week. Protein requirements are calculated at 1.2 to 1.5 g per kilogram of body weight per day. Enteral nutrition is given through nasogastric tube or nasointestinal tube.

Sponsors & Collaborators

  • Tang-Du Hospital

    collaborator OTHER
  • Xi'an Central Hospital

    collaborator OTHER
  • Xi'an Gaoxin Hospital

    collaborator OTHER
  • First Affiliated Hospital Xi'an Jiaotong University

    collaborator OTHER
  • Xi'an No.3 Hospital

    collaborator OTHER_GOV
  • First People's Hospital of Xianyang

    collaborator OTHER
  • Nanfang Hospital, Southern Medical University

    collaborator OTHER
  • Tongji Hospital

    collaborator OTHER
  • Qilu Hospital of Shandong University

    collaborator OTHER
  • The Second Hospital of Shandong University

    collaborator OTHER
  • PLA 960 Hospital

    collaborator UNKNOWN
  • Daping Hospital, The Third Military Medical University (Army Medical University)

    collaborator UNKNOWN
  • The Second Affiliated Hospital of Guangzhou University of Chinese Medicine

    collaborator UNKNOWN
  • First Hospital Affiliated to Zhengzhou University

    collaborator UNKNOWN
  • Gansu Provincial Central Hospital

    collaborator UNKNOWN
  • The First Hospital of Changsha City

    collaborator UNKNOWN
  • Shaanxi Provincial People's Hospital

    collaborator OTHER
  • Yulin No.2 Hospital

    collaborator OTHER
  • Yulin No.1 Hospital

    collaborator UNKNOWN
  • Xijing Hospital

    collaborator OTHER
  • Wen Jiang-3

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-20
Primary Completion
2026-07-31
Completion
2026-10-31

Countries

  • China

Study Locations

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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 NCT05998902 on ClinicalTrials.gov