Effect of an enteral diet enriched with gamma linolenic acid, eicosapentaenoic acid and antioxidants upon the course of critically ill patients with sepsis
- Conditions
- Systemic inflammatory response syndrome (SIRS)Infections and InfestationsOther septicaemia
- Registration Number
- ISRCTN67182335
- Lead Sponsor
- Spanish Society of Intensive Care (Sociedad Española de Medicina Intensiva) (Spain)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 272
Eligible patients are defined as those subjects who satisfy ALL of the following:
1. Aged 18 years or older, either sex
2. A diagnosis of sepsis during admission to the ICU, without the provision of artificial nutrition in the minimum required amount
3. An indication for enteral nutrition
4. Patient registration in the Secretariat before the start of treatment
5. Informed consent for participation in the study
Patients who present any of the following will NOT be eligible for inclusion in the study:
1. Established pregnancy
2. The reception of artificial nutrition in the 15 days prior to inclusion in the study
3. Known food allergy to any of the study diet components
4. Severe hyperlipidemia and hypertriglyceridemia
5. Gastrointestinal diseases precluding enteral nutrition (surgical resections, malabsorption, exacerbated inflammatory disease, persistent ileus, active upper digestive bleeding, etc.)
6. The impossibility of positioning the enteral nutrition tube
7. Immune depression, defined as:
7.1. Neutropenia (less than 1 x 10^9 neutrophils/l), or a prior diagnosis of myelodysplastic syndrome
7.2. Congenital immune deficiencies or acquired immune deficiency syndrome (AIDS) (Center for Disease Control and Prevention [CDC] criteria)
7.3. Systemic immunosuppressor therapy (including corticosteroids at prednisone equivalent doses of 1 mg/day or more) in the last 3 months
7.4. Systemic chemotherapy in the last 3 months
7.5. Autologous haematopoietic precursor cell transplantation in the previous year
7.6. Allogenic haematopoietic precursor cell transplantation in the last 2 years, or the existence of chronic graft versus host disease
8. Advanced chronic diseases:
8.1. Stage C chronic liver disease (Child Pugh)
8.2. Grade IV heart failure (New York Heart Association [NYHA])
8.3. Functional grade IV chronic respiratory failure
8.4. End stage degenerative neurological processes
8.5. End stage kidney failure
8.6. Neoplasms, either relapsing or in progression under treatment
9. Short life-expectancy processes:
9.1. Shock of any aetiology with multi-organ failure refractory to therapy in the first 48 hours
9.2. Fulminant acute hepatitis
9.3. Ischaemic haemorrhagic cerebrovascular accidents or head injuries with endocranial hypertension not controlled within 72 hours
9.4. Cardiogenic shock not overcome after 72 hours of specific treatment
9.5. Incoercible or recurrent serious acute haemorrhage for greater than 72 hours
9.6. Haemostatic disorders not controlled after 72 hours of specific treatment
9.7. Post-cardiopulmonary resuscitation with serious neurological damage 72 hours after arrest
10. Severe acute pancreatitis (except if infection is confirmed)
11. Administration of some experimental treatment in the past month, or present inclusion in another clinical study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method umber of new organ failures during admission to the ICU measured by changes in delta-Sequential Organ Failure Assessment (SOFA) score, measured at days 1, 3, 7, 14 and 21.
- Secondary Outcome Measures
Name Time Method 1. Number of stays in the ICU<br>2. Number of days of mechanical ventilation<br>3. Incidence of nosocomial infection (incidence density) throughout the stay in the ICU<br>4. Overall all-cause mortality (cumulative incidence on day +28)<br>5. Overall mortality during admission to the ICU<br>6. Overall mortality on day +180 from admission to the IC