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Impact of Early Enteral vs. Parenteral Nutrition on Mortality in Patients Requiring Mechanical Ventilation and Catecholamines (NUTRIREA2)

C

Centre Hospitalier Departemental Vendee

Status

Terminated

Conditions

Shock
Acute Respiratory Failure

Treatments

Other: Parenteral nutrition
Other: Enteral nutrition

Study type

Interventional

Funder types

Other

Identifiers

NCT01802099
CHD085-11

Details and patient eligibility

About

The purpose of this study is to assess the hypothesis that, as compared to early intravenous feeding, early nutrition via the enteral route is associated with reduced Day 28-mortality in critically ill patients treated with mechanical ventilation and vasoactive drug.

Enrollment

2,411 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Invasive mechanical ventilation expected to be required more than 48 hours
  • Nutrition started within 24 hours after initiation of endotracheal mechanical ventilation
  • Treatment with vasoactive drug administered via a central venous catheter
  • Age over 18 years
  • Signed information

Exclusion criteria

  • Abdominal surgery within 1 month before inclusion
  • History of esophageal, gastric, duodenal or pancreatic surgery
  • Bleeding from the esophagus, stomach or bowel
  • enteral nutrition via gastrostomy or jejunostomy
  • pregnancy
  • Treatment-limitation decisions
  • Current inclusion in a trial on comparison between enteral and parenteral nutrition

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

2,411 participants in 2 patient groups

Parenteral nutrition
Other group
Description:
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.
Treatment:
Other: Parenteral nutrition
Enteral nutrition
Other group
Description:
Patients will receive nutrition only via the enteral route during the firs week of invasive mechanical ventilation.
Treatment:
Other: Enteral nutrition

Trial contacts and locations

41

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Data sourced from clinicaltrials.gov

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