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

Not Applicable

Completed

• Conditions: Enteral Nutrition; Digestive System Neoplasms; Postoperative Period
• Interventions: Other: Enteral nutrition

• Registration Number: NCT03117348
• Lead Sponsor: Jinling Hospital, China

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.

Study Timeline

• Study First Submitted: 2017-03-30
• Study First Submitted QC: 2017-04-12
• Study Start: 2017-04-15
• Study First Posted: 2017-04-17
• Primary Completion: 2018-12-24
• Study Completion: 2019-02-16
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-21
• Last Update Posted: 2020-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 411

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Immediate goal-dose EN	Enteral nutrition	Patients in immediate Goal-dose EN group will reach the 100% of target energy by enteral nutrition at day 3 after abdominal surgery.
Gradual goal-dose EN	Enteral nutrition	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.

Primary Outcome Measures

Name	Time	Method
Morbidity of infection	From date of randomization until the date of infection from any cause, assessed up to 2 months.	Invasion of the host organism by microorganisms that can cause pathological conditions or diseases.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Jinling Hospital, China; 🇨🇳 Nanjing, Jiangsu, China