Effects of Delayed Enteral Nutrition on Inflammatory Responses and Immune Function Competence in Critically Ill Patients With Prolonged Fasting

NCT ID: NCT01834430

Last Updated: 2013-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28

Brief Summary

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.

Conditions

Severe Acute Pancreatitis Patients; Duodenal Fistula; Inflammatory Intestinal Obstruction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

EN group

The EN group gradually restored enteral nutrition, while the PN group continued to receive parenteral nutrition treatment. Both groups received between 20 to 25 kcal/kg/day and 1.5 g/kg/day of protein. Because of the low volume, concentration, and calorie amount, on the first day, tube feeding utilized 500 ml with the speed of 30 \~ 50 ml/h. On the second day, tube feeding utilized 1000 ml with the speed of 60 \~ 80 ml/h. On the third day, tube feeding utilized 1500 \~ 2000 ml with the speed of 100 \~ 120 ml/h. If enteral nutrition could not meet a patient's caloric requirements, PN supplement was started on the fourth day. The required calories and protein for each individual in the two groups was assumed to be achieved after three days of therapy. The PN group continued to receive parenteral nutrition.

Group Type: EXPERIMENTAL

enteral nutrition

Intervention Type: DIETARY_SUPPLEMENT

parenteral nutrient group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

enteral nutrition

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanjing PLA General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Gao Tao

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

2009NLY059

Identifier Type: -

Identifier Source: org_study_id