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Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT02897713
Other study ID # IEN
Secondary ID
Status Suspended
Phase N/A
First received
Last updated
Start date November 2016
Est. completion date June 2021

Study information

Verified date May 2020
Source Shanghai Zhongshan Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Patients with mechanical ventilation are in risk of malnutrition, which could lead to worse outcome. According to guidelines released from authority organizations, enteral nutrition (EN) should be prior approach for critically ill patients. However, initiation and delivery of EN during the early period of ICU admission are frequently hampered, which results in underfeeding. The investigators speculate whether an intensive enteral nutrition strategy could reinforce the delivery of EN thereby improving outcomes. In this multi-center, prospective, randomized parallel clinical trial, the investigators aim to assess the feasibility, safety and outcomes of intensive enteral nutrition in mechanical-ventilated patients.


Recruitment information / eligibility

Status Suspended
Enrollment 400
Est. completion date June 2021
Est. primary completion date December 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- predicted time of mechanical ventilation more than 48 hours

Exclusion Criteria:

- no enteral nutrition pathway

- refuse to informal consent

- surgeon refuse the protocol

- palliative care

Study Design


Related Conditions & MeSH terms


Intervention

Other:
intensive enteral nutrition
After recruitment, patients should be assessed for EN initiation during first 24 hours after ICU admission. 80% of energy target should be reached within 72 hours.
routine enteral nutrition
Attendings decide when and how EN should be administered according to guidelines from academic organizations, such as ESPEN or ASPEN.

Locations

Country Name City State
China 180 Fenglin Road Shanghai

Sponsors (12)

Lead Sponsor Collaborator
Shanghai Zhongshan Hospital RenJi Hospital, Shanghai 10th People's Hospital, Shanghai 6th People's Hospital, Shanghai East Hospital, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Jinshan Hospital, Shanghai Minhang Central Hospital, Shanghai Tong Ren Hospital, Shanghai Tongji Hospital, Tongji University School of Medicine, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Xuhui Central Hospital, Shanghai

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence rate of hospital-acquired infections Hospital-acquired infections include ventilator-associated pneumonia, bloodstream infection, and urinary catheter-associated infection 28 days after ICU admission
Secondary mortality of 28 days 28 days after ICU admission
Secondary ICU stay from ICU admission to timepoint of patient's discharge or death, up to 12 months
Secondary free days of mechanical ventilation during whole ICU stay, up to 12 months
Secondary rate of reaching 80% of energy target during 72 hours first 72 hours after ICU admission
Secondary EN-associated adverse events during whole ICU stay, up to 12 months
Secondary rate of parenteral nutrition delivery during whole ICU stay, up to 12 months
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