Feasibility, Safety, and Outcomes of Intensive Enteral Nutrition in Patients With Mechanical Ventilation

Critical Illness Clinical Trial

Official title:

Feasibility, Safety and Outcomes of Intensive Enteral Nutrition in Mechanical-ventilated Patients: a Multicenter, Parallel Randomized Trial

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT02897713
• Other study ID #: IEN
• Status: Suspended
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Critical Illness

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