Safety Study of Feeding With Ginger Extract in Acute Respiratory Distress Syndrome

Shahid Beheshti University

Status and phase

Completed

Phase 2

Conditions

Acute Respiratory Distress Syndrome

Treatments

Dietary Supplement: placebo

Dietary Supplement: ginger

Study type

Interventional

Funder types

Other

Identifiers

NCT00958685

INFI-112

Details and patient eligibility

About

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).

Full 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.

Enrollment

32 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.