Gradual Versus Immediate Goal-dose Enteral Nutrition in Abdominal Surgery Patients

Study Overview
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Brief Summary
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Patients will be randomized to Gradual or immediate Goal-dose EN group at day 3 after abdominal surgery. Patients will receive Goal-dose EN gradually or immediately after abdominal surgery. Both groups will receive EN for 5 days except 80% of target energy delivered by oral feeding or patients are discharged from hospital. The primary and secondary outcomes will be collected.

Detailed Description
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Patients after abdominal surgery will receive enteral nutrition for 2 days, if she/he can tolerate 30% of goal-dose EN, then she/he will be randomized to Gradual or immediate Goal-dose EN group at day 3. Patients in Gradual Goal-dose EN group will receive increased calories gradually by EN and will reach the 80% of target energy by EN at day 8 while patients in immediate Goal-dose EN group will receive 100% of target energy by EN at day 3 after abdominal surgery. Both groups will receive EN for 5 days except 80% of target energy delivered by oral feeding or patients are discharged from hospital, whichever arrives first. The primary and secondary outcomes will be collected.

Official Title
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Gradual Versus Immediate Goal-dose Enteral Nutrition in Abdominal Surgery Patients: A Clinical Randomized Controlled Trial

Conditions
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Enteral Nutrition, Postoperative Period, Digestive System Neoplasms

Intervention / Treatment
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* Other: Enteral nutrition


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed consent of patients or their legal representatives to participate in this study. patients undergoing selective operation without trauma patients following medium or major abdominal surgery NRS 2002≥ 3 Exclusion Criteria: Psychiatric disorders Pregnancy or breast-feeding women Malnutrition Weight loss >10%-15% in 6 months BMI<18.5 SGA score with stage C Albumin < 30g/L Unstable vital signs or unstable hemodynamics (such as systolic blood pressure < 90 mmHg or mean arterial pressure < 70 mmHg after rapid 500 ml crystal or 200 ml gel infusion, or the 50% increase of vascular active drug infusion rate in an hour, etc) Refuse to participate in the study Mortality rates expected to more than 50% in 6 months with malignant or irreversibility diseases Cancer in terminal stage or HIV positive at end-stage or CD4 < 50/mm3 Cardiopulmonary resuscitation (CPR) before cardiac arrest and nervous system function not fully recovery Four levels of physical activity of the patients defined by New York heart association Rely on breathing machine because of chronic diseases Life expectancy less than 24 hours of dying patients Refractory shock to meet any of the following article The infusion rate of dopamine > 15 ug/kg/min The infusion rate of dobutamine > 15 ug/kg/min The infusion rate of epinephrine and norepinephrine > 30 ug/min The infusion rate of phenylephrine > 50 ug/min The infusion rate of milrinone > 0.5 ug/kg/min The infusion rate of vasopressin > 0.04 U/min Inter aortic ballon pump (IABP) Hepatic insufficiency (alanine/aspartate transaminase/bilirubin 200% above normal range) Renal insufficiency(creatinine 200% above normal range) Metabolic diseases（hyperthyroidism/ hypothyroidism, adrenal cortex disorders) EN can not reach 30% of target energy in 48 hours after surgery Burn area exceeding 20% of the patient's body surface Autoimmune diseases or immune dysfunction or history of organ transplantation International standardization ratio (INR) more than 3.0 or platelet count < 30000 cells/mm3 or other hemorrhagic diathesis Intracranial hemorrhage one month before enrolment General contraindications to infusion therapy or history of severe allergy against ingredients of enteral and parenteral nutrition Has already participated in another clinical trial Has started to nutritional support therapy before enrolment Diabetes mellitus (anamnestic and/or under medical treatment)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gradual goal-dose EN<br>Patients in Gradual Goal-dose EN group will receive increased calories gradually by enteral nutrition and will reach the 80% of target energy by enteral nutrition at day 8. | Other: Enteral nutrition<br>* Patients in Gradual Goal-dose EN group will receive increased calories gradually by EN and will reach the 80% of target energy by EN at day 8 while patients in immediate Goal-dose EN group will receive 100% of target energy by EN at day 3 after abdominal surgery. Both of the two group will receive EN for 5 days except 80% of target energy delivered by oral feeding or patients are discharged from hospital, whichever arrives first.<br>|
| Experimental: Immediate goal-dose EN<br>Patients in immediate Goal-dose EN group will reach the 100% of target energy by enteral nutrition at day 3 after abdominal surgery. | Other: Enteral nutrition<br>* Patients in Gradual Goal-dose EN group will receive increased calories gradually by EN and will reach the 80% of target energy by EN at day 8 while patients in immediate Goal-dose EN group will receive 100% of target energy by EN at day 3 after abdominal surgery. Both of the two group will receive EN for 5 days except 80% of target energy delivered by oral feeding or patients are discharged from hospital, whichever arrives first.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morbidity of infection | Invasion of the host organism by microorganisms that can cause pathological conditions or diseases. | From date of randomization until the date of infection from any cause, assessed up to 2 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Actual calories intake | The total energy patients received during the intervention. | During the intervention, assessed up to 2 months. | 
| Scale the frequency of gastrointestinal intolerance | Diarrhea, vomiting, abdominal distention or cramping and abdominal pain. | During the intervention, assessed up to 2 months. | 
| Laboratory examination | Albumin, pre-albumin, transferrin and retinol conjugated protein | At the date of patients enrollment and after intervention, assessed up to 2 months. | 
| Length of stay in hospital | The length of patients stay in hospital | From date of operation until the date of patients discharged from hospital, assessed up to 12 months. | 
| Mortality | All deaths reported in all enrolled patients. | From date of randomization until the date of death, assessed up to 2 months after patients discharged from hospital. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Enteral Nutrition, Digestive System Neoplasms, Randomized Controlled Trial, Clinical Outcomes