Status:
COMPLETED
Safety Study of Feeding With Ginger Extract in Acute Respiratory Distress Syndrome
Lead Sponsor:
Shahid Beheshti University
Conditions:
Acute Respiratory Distress Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
An enteral diet supplemented with ginger extract in acute respiratory distress syndrome (ARDS) patients may be beneficial for gas exchange and could decrease duration of mechanical ventilation and len...
Detailed Description
Rationale: Clinical ARDS occurs primarily as the result of inflammatory injury to the alveoli producing diffuse alveolar damage. Objective: To evaluate the effects of an enteral diet enriched with gi...
Eligibility Criteria
Inclusion
- Required positive pressure ventilation via endotracheal tube or tracheostomy and were on enteral nutrition support.
- Also they had to have an acute onset of significantly impaired oxygenation with a PaO2 to FiO2 ratio equal or less than 200, bilateral pulmonary infiltrates on frontal chest radiograph and no clinical evidence of left atrial hypertension according to the American-European Consensus Conference on ARDS .
- Patients had to be enrolled within 48 hours of developing these criteria.
Exclusion
- Age younger than 18 years
- Participation in other interventional trials in the previous 30 days
- Neurological conditions that could impair weaning from ventilatory support,
- Severe chronic respiratory disease
- Pregnancy
- Lactation
- Active bleeding
- Head trauma
- Intracranial hemorrhage
- Peptic ulcer
- HIV infection
- Food allergy
- Morbid obesity
- Malignancy or other irreversible conditions for which 6 months mortality was estimated to be 50% or more and who were receiving nonsteroidal anti inflammatory drugs or ketoconazole.
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00958685
Start Date
January 1 2007
End Date
January 1 2009
Last Update
August 13 2009
Active Locations (1)
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1
Faculty of Nutrition Sciences and Food Technology
Tehran, Iran