Trial Outcomes & Findings for Impact of Early Enteral vs. Parenteral Nutrition on Mortality in Patients Requiring Mechanical Ventilation and Catecholamines (NCT NCT01802099)

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

2410 participants

Primary outcome timeframe

28 days

Results posted on

2026-04-16

Participant Flow

Participant milestones

Participant milestones
Measure	Parenteral Nutrition Patients will receive parenteral nutrition during the first week of mechanical ventilation. After Day 3, the parenteral route may be switched to the enteral route if shock resolve (vasoactive drug stopped since 24 hours and serum lactate level \< 2 mmol/l). After Day 7, all patients will be fed via the enteral route. Parenteral nutrition	Enteral Nutrition Patients will receive nutrition only via the enteral route during the firs week of invasive mechanical ventilation. Enteral nutrition
Overall Study STARTED	1208	1202
Overall Study COMPLETED	1208	1202
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Parenteral Nutrition n=1208 Participants Patients will receive parenteral nutrition during the first week of mechanical ventilation. After Day 3, the parenteral route may be switched to the enteral route if shock resolve (vasoactive drug stopped since 24 hours and serum lactate level \< 2 mmol/l). After Day 7, all patients will be fed via the enteral route. Parenteral nutrition	Enteral Nutrition n=1202 Participants Patients will receive nutrition only via the enteral route during the firs week of invasive mechanical ventilation. Enteral nutrition	Total n=2410 Participants Total of all reporting groups
Age, Continuous	66 years STANDARD_DEVIATION 14 • n=1208 Participants	66 years STANDARD_DEVIATION 14 • n=1202 Participants	66 years STANDARD_DEVIATION 14 • n=2410 Participants
Sex: Female, Male Female	815 Participants n=1208 Participants	809 Participants n=1202 Participants	1624 Participants n=2410 Participants
Sex: Female, Male Male	393 Participants n=1208 Participants	393 Participants n=1202 Participants	786 Participants n=2410 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment France	1208 participants n=1208 Participants	1202 participants n=1202 Participants	2410 participants n=2410 Participants

PRIMARY outcome

Timeframe: 28 days

Outcome measures

Outcome measures
Measure	Parenteral Nutrition n=1208 Participants Patients will receive parenteral nutrition during the first week of mechanical ventilation. After Day 3, the parenteral route may be switched to the enteral route if shock resolve (vasoactive drug stopped since 24 hours and serum lactate level \< 2 mmol/l). After Day 7, all patients will be fed via the enteral route. Parenteral nutrition	Enteral Nutrition n=1202 Participants Patients will receive nutrition only via the enteral route during the firs week of invasive mechanical ventilation. Enteral nutrition
Mortality	422 Participants	443 Participants

SECONDARY outcome

Timeframe: 90 days

Population: Patient dead at day 28 are not analysed

Outcome measures

Outcome measures
Measure	Parenteral Nutrition n=1192 Participants Patients will receive parenteral nutrition during the first week of mechanical ventilation. After Day 3, the parenteral route may be switched to the enteral route if shock resolve (vasoactive drug stopped since 24 hours and serum lactate level \< 2 mmol/l). After Day 7, all patients will be fed via the enteral route. Parenteral nutrition	Enteral Nutrition n=1185 Participants Patients will receive nutrition only via the enteral route during the firs week of invasive mechanical ventilation. Enteral nutrition
Mortality Rate	507 Participants	530 Participants

SECONDARY outcome

Timeframe: until weaning of mechanical ventilation (average: 7 days)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: until discharge from ICU (average: 10 days)

Bloodstream infection Urinary tract infection Catheter-related infection Other infections

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: until discharge from ICU (average: 10 days)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: until discharge from hospital (average: 17 days)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: first week (7 days) of mechanical ventilation

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: until weaning of mechanical ventilation (average : 7 days)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: until weaning of mechanical ventilation (average: 7 days)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the first week (7 days) of mechanical ventilation

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Until discharge from hospital (average : 17 days)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: until discharge from ICU (average: 10 days)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: until weaning of mechanical ventilation (average: 7 days)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: until weaning of mechanical ventilation (average: 7 days)

Outcome measures

Outcome data not reported

Adverse Events

Parenteral Nutrition

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Enteral Nutrition

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Jean REIGNIER

CHD Vendée

Phone: 0251446572

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place