Clinical trial NCT03117348: Gradual Versus Immediate Goal-dose Enteral Nutrition in Abdominal Surgery Patients
Official title: Gradual Versus Immediate Goal-dose Enteral Nutrition in Abdominal Surgery Patients: A Clinical Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Enteral Nutrition
Postoperative Period
Digestive System Neoplasms
Keywords: Enteral Nutrition
Digestive System Neoplasms
Randomized Controlled Trial
Clinical Outcomes
Lead sponsor: Jinling Hospital, China
Sponsor class: OTHER
Collaborators: name: Peking Union Medical College Hospital
name: Chinese PLA General Hospital
name: First Affiliated Hospital, Sun Yat-Sen University
name: Xijing Hospital
name: West China Hospital
name: Xinqiao Hospital of Chongqing
name: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Changhai Hospital
name: Shanghai 10th People's Hospital
name: The Second Affiliated Hospital of Harbin Medical University
name: The Affiliated Hospital of Qingdao University
name: First Affiliated Hospital of Kunming Medical University
First posted: 2017-04-17
Enrollment: 411
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

1. Informed consent of patients or their legal representatives to participate in this study.
2. patients undergoing selective operation without trauma
3. patients following medium or major abdominal surgery
4. NRS 2002≥ 3

Exclusion Criteria:

1. Psychiatric disorders
2. Pregnancy or breast-feeding women
3. Malnutrition

   1. Weight loss \>10%-15% in 6 months
   2. BMI\<18.5
   3. SGA score with stage C
   4. Albumin \< 30g/L
4. 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)
5. Refuse to participate in the study
6. Mortality rates expected to more than 50% in 6 months with malignant or irreversibility diseases

   1. Cancer in terminal stage or
   2. HIV positive at end-stage or CD4 \< 50/mm3
   3. Cardiopulmonary resuscitation (CPR) before cardiac arrest and nervous system function not fully recovery
   4. Four levels of physical activity of the patients defined by New York heart association
   5. Rely on breathing machine because of chronic diseases
7. Life expectancy less than 24 hours of dying patients
8. Refractory shock to meet any of the following article

   1. The infusion rate of dopamine \> 15 ug/kg/min
   2. The infusion rate of dobutamine \> 15 ug/kg/min
   3. The infusion rate of epinephrine and norepinephrine \> 30 ug/min
   4. The infusion rate of phenylephrine \> 50 ug/min
   5. The infusion rate of milrinone \> 0.5 ug/kg/min
   6. The infusion rate of vasopressin \> 0.04 U/min
   7. Inter aortic ballon pump (IABP)
9. Hepatic insufficiency (alanine/aspartate transaminase/bilirubin 200% above normal range)
10. Renal insufficiency(creatinine 200% above normal range)
11. Metabolic diseases（hyperthyroidism/ hypothyroidism, adrenal cortex disorders)
12. EN can not reach 30% of target energy in 48 hours after surgery
13. Burn area exceeding 20% of the patient's body surface
14. Autoimmune diseases or immune dysfunction or history of organ transplantation
15. International standardization ratio (INR) more than 3.0 or platelet count \< 30000 cells/mm3 or other hemorrhagic diathesis
16. Intracranial hemorrhage one month before enrolment
17. General contraindications to infusion therapy or history of severe allergy against ingredients of enteral and parenteral nutrition
18. Has already participated in another clinical trial
19. Has started to nutritional support therapy before enrolment
20. Diabetes mellitus (anamnestic and/or under medical treatment)

Primary outcomes:
measure: Morbidity of infection
timeFrame: From date of randomization until the date of infection from any cause, assessed up to 2 months.
Secondary outcomes:
measure: Actual calories intake
timeFrame: During the intervention, assessed up to 2 months.
measure: Scale the frequency of gastrointestinal intolerance
timeFrame: During the intervention, assessed up to 2 months.
measure: Laboratory examination
timeFrame: At the date of patients enrollment and after intervention, assessed up to 2 months.
measure: Length of stay in hospital
timeFrame: From date of operation until the date of patients discharged from hospital, assessed up to 12 months.
measure: Mortality
timeFrame: From date of randomization until the date of death, assessed up to 2 months after patients discharged from hospital.
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Jinling Hospital, China
state: Jiangsu
Study officials:
affiliation: Jinling Hospital, China
name: Xinying Wang, MD
role: PRINCIPAL_INVESTIGATOR
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