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

September 21, 2020 updated by: Wang Xinying, Jinling Hospital, China

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

411

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210002
        • Jinling Hospital, China

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Morbidity of infection
Time Frame: 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.
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
Time Frame: During the intervention, assessed up to 2 months.
The total energy patients received during the intervention.
During the intervention, assessed up to 2 months.
Scale the frequency of gastrointestinal intolerance
Time Frame: During the intervention, assessed up to 2 months.
Diarrhea, vomiting, abdominal distention or cramping and abdominal pain.
During the intervention, assessed up to 2 months.
Laboratory examination
Time Frame: At the date of patients enrollment and after intervention, assessed up to 2 months.
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
Time Frame: From date of operation until the date of patients discharged from hospital, assessed up to 12 months.
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
Time Frame: 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.
From date of randomization until the date of death, assessed up to 2 months after patients discharged from hospital.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jinling Hospital, China

Collaborators

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

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2017

Primary Completion (Actual)

December 24, 2018

Study Completion (Actual)

February 16, 2019

Study Registration Dates

First Submitted

March 30, 2017

First Submitted That Met QC Criteria

April 12, 2017

First Posted (Actual)

April 17, 2017

Study Record Updates

Last Update Posted (Actual)

September 22, 2020

Last Update Submitted That Met QC Criteria

September 21, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201502022-21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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