Acute Respiratory Distress Syndrome
Conditions
Keywords
ginger extract, ARDS, enteral feeding, mechanical ventilation, ICU
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 length of stay in intensive care unit (ICU).
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 ginger extract on inflammatory factors, respiratory profile and outcome of patients with ARDS. Methods: In this single center, randomized, controlled double blind study, 32 patients with ARDS were randomized to receive a high protein enteral diet enriched with ginger extract or placebo. Measurements and Main Results: Serum levels of IL-1, IL-6, TNF-α and LTB-4, oxygenation, measured as PaO2/FiO2, static compliance measured on days 0, 5 and 10. Patients fed enteral diet enriched with ginger extract had significantly lower serum levels of IL-1, IL-6, TNF-α and LTB-4 on days 5 and 10 compared to control group (P\<0.05). Significant improvement in oxygenation was observed on day 5 (P=0.02) and 10 (P=0.003) in ginger extract group compared to control group. Static compliance was also increased significantly on day 5 (P=0.01) in ginger extract group compared to control group. A significant difference was found in duration of mechanical ventilation (P0.02) and length of ICU stay (P=0.04) in favor of ginger extract group. We did not find any difference in barotraumas, organ failure and mortality between the study groups. Conclusions: An enteral diet supplemented with ginger extract in ARDS patients may be beneficial for gas exchange and could decrease duration of mechanical ventilation and length of stay in ICU.
Interventions
DIETARY_SUPPLEMENTginger
Study group received 1200 mg of ginger extract and control group 2 gram of coconut oil as placebo
DIETARY_SUPPLEMENTplacebo
Study group received 1200 mg of ginger extract and control group 2 gram of coconut oil as placebo
Sponsors
Shahid Beheshti University
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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 criteria
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| changes in oxygenation, respiratory mechanics and serum inflammatory factors | 21 days |
| oxygenation | 21 days |
Secondary
| Measure | Time frame |
|---|---|
| the number of organ failure free days, the occurrence of barotraumas, the number of ventilator free days, the number of ICU free days and ICU mortality. | after intervention |
Countries
Iran
Outcome results
None listed