Clinical trial NCT00958685: Safety Study of Feeding With Ginger Extract in Acute Respiratory Distress Syndrome
Official title: Effect of Enteral Feeding With Ginger Extract in Acute Respiratory Distress Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Respiratory Distress Syndrome
Keywords: ginger extract
ARDS
enteral feeding
mechanical ventilation
ICU
Lead sponsor: Shahid Beheshti University
Sponsor class: OTHER
First posted: 2009-08-13
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: changes in oxygenation, respiratory mechanics and serum inflammatory factors
timeFrame: 21 days
measure: oxygenation
timeFrame: 21 days
Secondary outcomes:
measure: 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.
timeFrame: after intervention
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Faculty of Nutrition Sciences and Food Technology
Study officials:
affiliation: Faculty of Nutrition Sciences and Food Technology
name: zahra vahdat shariatpanahi, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: