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

Sponsor
Jinling Hospital, China (Other)
Overall Status
Completed
CT.gov ID
NCT03117348
Collaborator
Peking Union Medical College Hospital (Other), Chinese PLA General Hospital (Other), First Affiliated Hospital, Sun Yat-Sen University (Other), Xijing Hospital (Other), West China Hospital (Other), Xinqiao Hospital of Chongqing (Other), Second Affiliated Hospital, School of Medicine, Zhejiang University (Other), Changhai Hospital (Other), Shanghai 10th People's Hospital (Other), The Second Affiliated Hospital of Harbin Medical University (Other), The Affiliated Hospital of Qingdao University (Other), The First Affiliated Hospital of Kunming Medical College (Other)
411
Enrollment
1
Location
2
Arms
22.1
Actual Duration (Months)
18.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Enteral nutrition
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
411 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Gradual Versus Immediate Goal-dose Enteral Nutrition in Abdominal Surgery Patients: A Clinical Randomized Controlled Trial
Actual Study Start Date :
Apr 15, 2017
Actual Primary Completion Date :
Dec 24, 2018
Actual Study Completion Date :
Feb 16, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Gradual goal-dose EN

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
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.
Experimental: Immediate goal-dose EN

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
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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Actual calories intake [During the intervention, assessed up to 2 months.]

    The total energy patients received during the intervention.

  2. Scale the frequency of gastrointestinal intolerance [During the intervention, assessed up to 2 months.]

    Diarrhea, vomiting, abdominal distention or cramping and abdominal pain.

  3. Laboratory examination [At the date of patients enrollment and after intervention, assessed up to 2 months.]

    Albumin, pre-albumin, transferrin and retinol conjugated protein

  4. 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

  5. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

  4. Weight loss >10%-15% in 6 months

  5. BMI<18.5

  6. SGA score with stage C

  7. Albumin < 30g/L

  8. 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)

  9. Refuse to participate in the study

  10. Mortality rates expected to more than 50% in 6 months with malignant or irreversibility diseases

  11. Cancer in terminal stage or

  12. HIV positive at end-stage or CD4 < 50/mm3

  13. Cardiopulmonary resuscitation (CPR) before cardiac arrest and nervous system function not fully recovery

  14. Four levels of physical activity of the patients defined by New York heart association

  15. Rely on breathing machine because of chronic diseases

  16. Life expectancy less than 24 hours of dying patients

  17. Refractory shock to meet any of the following article

  18. The infusion rate of dopamine > 15 ug/kg/min

  19. The infusion rate of dobutamine > 15 ug/kg/min

  20. The infusion rate of epinephrine and norepinephrine > 30 ug/min

  21. The infusion rate of phenylephrine > 50 ug/min

  22. The infusion rate of milrinone > 0.5 ug/kg/min

  23. The infusion rate of vasopressin > 0.04 U/min

  24. Inter aortic ballon pump (IABP)

  25. Hepatic insufficiency (alanine/aspartate transaminase/bilirubin 200% above normal range)

  26. Renal insufficiency(creatinine 200% above normal range)

  27. Metabolic diseases（hyperthyroidism/ hypothyroidism, adrenal cortex disorders)

  28. EN can not reach 30% of target energy in 48 hours after surgery

  29. Burn area exceeding 20% of the patient's body surface

  30. Autoimmune diseases or immune dysfunction or history of organ transplantation

  31. International standardization ratio (INR) more than 3.0 or platelet count < 30000 cells/mm3 or other hemorrhagic diathesis

  32. Intracranial hemorrhage one month before enrolment

  33. General contraindications to infusion therapy or history of severe allergy against ingredients of enteral and parenteral nutrition

  34. Has already participated in another clinical trial

  35. Has started to nutritional support therapy before enrolment

  36. Diabetes mellitus (anamnestic and/or under medical treatment)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Jinling Hospital, China Nanjing Jiangsu China 210002

Sponsors and Collaborators

  • Jinling Hospital, China
  • Peking Union Medical College Hospital
  • Chinese PLA General Hospital
  • First Affiliated Hospital, Sun Yat-Sen University
  • Xijing Hospital
  • West China Hospital
  • Xinqiao Hospital of Chongqing
  • Second Affiliated Hospital, School of Medicine, Zhejiang University
  • Changhai Hospital
  • Shanghai 10th People's Hospital
  • The Second Affiliated Hospital of Harbin Medical University
  • The Affiliated Hospital of Qingdao University
  • The First Affiliated Hospital of Kunming Medical College

Investigators

  • Principal Investigator: Xinying Wang, MD, Jinling Hospital, China

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Wang Xinying, Professor, Jinling Hospital, China
ClinicalTrials.gov Identifier:
NCT03117348
Other Study ID Numbers:
  • 201502022-21
First Posted:
Apr 17, 2017
Last Update Posted:
Sep 22, 2020
Last Verified:
Sep 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Wang Xinying, Professor, Jinling Hospital, China
Enteral Nutrition
Digestive System Neoplasms
Randomized Controlled Trial
Clinical Outcomes
Additional relevant MeSH terms:
Digestive System Neoplasms
Gastrointestinal Neoplasms

Study Results

No Results Posted as of Sep 22, 2020