Duodenal Fistula Clinical Trial
Official title:
Effects of Delayed Enteral Nutrition on Inflammatory Responses and Immune Function Competence in Critically Ill Patients With Prolonged Fasting
| NCT number | NCT01834430 |
| Other study ID # | 2009NLY059 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 3 |
| First received | April 7, 2013 |
| Last updated | April 15, 2013 |
| Start date | February 2010 |
| Verified date | April 2013 |
| Source | Nanjing PLA General Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | China: National Natural Science Foundation |
| Study type | Interventional |
Different studies suggest that early enteral nutrition (EEN) has benefits in reducing infectious complications, there is no data that addresses whether delayed enteral nutrition (EN) is detrimental and if it may have effects on inflammatory responses and immune function.
| Status | Completed |
| Enrollment | 45 |
| Est. completion date | |
| Est. primary completion date | February 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 60 Years |
| Eligibility |
Inclusion Criteria: - having a fasting time of more than 14 days - American Society of Anesthesiologists (ASA) physical status ranging between 1 and 3, and their condition allows enteral nutrition therapy. Exclusion Criteria: - chronic renal failure (peritoneal or hemodialysis or creatinine > 2.5 mg/dl) - history of chronic obstructive pulmonary disease - hepatic dysfunction or cirrhosis or a bilirubin value > 3 mg/dl - metabolic diseases,severe anemia - blood coagulation dysfunction - pregnancy lactation - history of psychiatric illness - patients underwent immunosuppressive therapy |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Nanjing PLA General Hospital |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | inflammatory markers | white blood cell count, C reactive protein(CRP), pro-inflammatory cytokines (TNF-a,IL-1,IL-6), and anti-inflammatory cytokines (IL-4, IL-10) | 7 days | No |
| Primary | all cause mortality | 28 days | No | |
| Secondary | organ failure | 7 days | No |