NCT01464853

Brief Summary

To determine whether specialized enteral nutrition support can improve oxygenation status in critically ill patients with acute lung injury (ALI) or acute respiratory distress syndrome (ARDS) comparing to a standard enteral nutritional formula.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2010

Shorter than P25 for phase_3

Geographic Reach
1 country

9 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 1, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 4, 2011

Completed
Last Updated

November 4, 2011

Status Verified

March 1, 2011

Enrollment Period

1 year

First QC Date

November 1, 2011

Last Update Submit

November 2, 2011

Conditions

Respiratory Distress Syndrome,AdultAcute Lung Injury

Outcome Measures

Primary Outcomes (1)

  • Oxygenation status improvement

    28 days

Secondary Outcomes (8)

  • Length of ventilation

    28 days

  • Length of ICU stay

    28 days

  • Incidence of organ failures

    28 days

  • Incidence of ventilator-associated pneumonia

    28 days

  • Mortality

    28 days

  • +3 more secondary outcomes

Study Arms (2)

Specialized Enteral Nutrition

EXPERIMENTAL

Enteral Feeding to provide 25 kcal/Kg/day

Other: Enteral nutrition with fatty acids

Standard Enteral Nutrition

ACTIVE COMPARATOR

Enteral Feeding to provide 25 kcal/Kg/day

Other: Standard Enteral Nutrition

Interventions

Enteral nutrition with fatty acidsOTHER

Enteral Feeding to provide 25 kcal/Kg/day

Specialized Enteral Nutrition
Standard Enteral NutritionOTHER

Enteral Feeding to provide 25 kcal/Kg/day

Standard Enteral Nutrition

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or non-pregnant female.
  • ALI or ARDS
  • PaO2/FiO2 \> 100 and ≤ 300 torr.
  • Evidence of bilateral pulmonary infiltrates/opacity on chest radiograph.
  • Enteral access
  • Systemic inflammatory response syndrome (SIRS) - two or more of the following must be present:
  • Body temperature less than 36°C or greater than 38°C
  • Heart rate \> 90 beats per minute
  • Tachypnea with \> 20 breaths per minute; or an arterial partial pressure of carbon dioxide \< 4.3 kPa (32 mmHg)
  • White blood cell count \< 4000 cells/mm³ or \> 12,000 cells/mm³; or the presence of \> 10% immature neutrophils.

You may not qualify if:

  • Dialysis for renal failure
  • Anticipated life expectancy less than 24 hours.
  • Patient with severe chronic liver disease
  • Neuromuscular disease that impairs ability to ventilate without assistance
  • Head trauma and/or drowning with a Glasgow coma score of 5
  • Receiving intravenous lipid emulsions from parenteral nutrition within 12 hours of baseline.
  • Receiving propofol
  • Airway reconstructive surgery.
  • Malignancy or irreversible disease for which 6-month mortality is greater than 50%.
  • Burns greater than 25% total body surface area.
  • Unwillingness or inability to utilize the ARDS network ventilation protocol.
  • HIV positive.
  • Chronic mechanical ventilation.
  • Severe, acute pancreatitis.
  • Refractory shock
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

1st City Clinical Emergency Hospital n.a. E.E. Volosevich

Arkhangelsk, 163001, Russia

Location

City Clinical Hospital #2

Krasnodar, 350012, Russia

Location

Krasnoyarsk State Medical University n.a. Prof V.F. Voyno-Yasenetskogo

Krasnoyarsk, 660022, Russia

Location

Central Clinical Hospital #1

Moscow, 125367, Russia

Location

State Novosibirsk Regional Clinical Hospital

Novosibirsk, 630087, Russia

Location

Clinical Medical Unit #1

Perm, 614010, Russia

Location

St. Petersburg Scientific Research Institute of Emergency Care n.a. I.I.Dzhanelidze

Saint Petersburg, 192442, Russia

Location

Republican Clinical Hospital n.a. G.G. Kuvatova

Ufa, 45005, Russia

Location

Central City Hospital #7

Yekaterinburg, 620109, Russia

Location

MeSH Terms

Conditions

Respiratory Distress SyndromeAcute Lung Injury

Interventions

Enteral NutritionFatty Acids

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration DisordersLung Injury

Intervention Hierarchy (Ancestors)

Feeding MethodsTherapeuticsNutritional SupportNutrition TherapyLipids

Study Officials

  • Menghua Luo, MD, PhD

    Abbott Nutrition

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 2011

First Posted

November 4, 2011

Study Start

April 1, 2010

Primary Completion

April 1, 2011

Study Completion

May 1, 2011

Last Updated

November 4, 2011

Record last verified: 2011-03

Locations

RU(9)