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Completed

NCT Number: NCT03117348

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jinling Hospital, China

Nanjing, Jiangsu, 210002, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Enteral nutrition

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Actual calories intake

    Time frame: During the intervention, assessed up to 2 months.

    The total energy patients received during the intervention.

  2. 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.

  3. 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

  4. 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

  5. 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.

Sponsors and collaborators

Lead sponsor

Jinling Hospital, China

Other

Collaborators

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

Registry information

Official study title

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

Acronym: GIGENAS

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Apr 17, 2017
Registry last updated
Sep 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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