search
Back to results

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

Primary Purpose

Enteral Nutrition, Postoperative Period, Digestive System Neoplasms

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Enteral nutrition
Sponsored by
Jinling Hospital, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Enteral Nutrition focused on measuring Enteral Nutrition, Digestive System Neoplasms, Randomized Controlled Trial, Clinical Outcomes

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Jinling Hospital, China

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Gradual goal-dose EN

Immediate goal-dose EN

Arm Description

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.

Patients in immediate Goal-dose EN group will reach the 100% of target energy by enteral nutrition at day 3 after abdominal surgery.

Outcomes

Primary Outcome Measures

Morbidity of infection
Invasion of the host organism by microorganisms that can cause pathological conditions or diseases.

Secondary Outcome Measures

Actual calories intake
The total energy patients received during the intervention.
Scale the frequency of gastrointestinal intolerance
Diarrhea, vomiting, abdominal distention or cramping and abdominal pain.
Laboratory examination
Albumin, pre-albumin, transferrin and retinol conjugated protein
Length of stay in hospital
The length of patients stay in hospital
Mortality
All deaths reported in all enrolled patients.

Full Information

First Posted
March 30, 2017
Last Updated
September 21, 2020
Sponsor
Jinling Hospital, China
Collaborators
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, First Affiliated Hospital of Kunming Medical University
search

1. Study Identification

Unique Protocol Identification Number
NCT03117348
Brief Title
Gradual Versus Immediate Goal-dose Enteral Nutrition in Abdominal Surgery Patients
Acronym
GIGENAS
Official Title
Gradual Versus Immediate Goal-dose Enteral Nutrition in Abdominal Surgery Patients: A Clinical Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
April 15, 2017 (Actual)
Primary Completion Date
December 24, 2018 (Actual)
Study Completion Date
February 16, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jinling Hospital, China
Collaborators
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, First Affiliated Hospital of Kunming Medical University

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Enteral Nutrition, Postoperative Period, Digestive System Neoplasms
Keywords
Enteral Nutrition, Digestive System Neoplasms, Randomized Controlled Trial, Clinical Outcomes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
411 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gradual goal-dose EN
Arm Type
Experimental
Arm Description
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.
Arm Title
Immediate goal-dose EN
Arm Type
Experimental
Arm Description
Patients in immediate Goal-dose EN group will reach the 100% of target energy by enteral nutrition at day 3 after abdominal surgery.
Intervention Type
Other
Intervention Name(s)
Enteral nutrition
Intervention Description
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 Outcome Measure Information:
Title
Morbidity of infection
Description
Invasion of the host organism by microorganisms that can cause pathological conditions or diseases.
Time Frame
From date of randomization until the date of infection from any cause, assessed up to 2 months.
Secondary Outcome Measure Information:
Title
Actual calories intake
Description
The total energy patients received during the intervention.
Time Frame
During the intervention, assessed up to 2 months.
Title
Scale the frequency of gastrointestinal intolerance
Description
Diarrhea, vomiting, abdominal distention or cramping and abdominal pain.
Time Frame
During the intervention, assessed up to 2 months.
Title
Laboratory examination
Description
Albumin, pre-albumin, transferrin and retinol conjugated protein
Time Frame
At the date of patients enrollment and after intervention, assessed up to 2 months.
Title
Length of stay in hospital
Description
The length of patients stay in hospital
Time Frame
From date of operation until the date of patients discharged from hospital, assessed up to 12 months.
Title
Mortality
Description
All deaths reported in all enrolled patients.
Time Frame
From date of randomization until the date of death, assessed up to 2 months after patients discharged from hospital.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xinying Wang, MD
Organizational Affiliation
Jinling Hospital, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jinling Hospital, China
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210002
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
10990103
Citation
Bauer P, Charpentier C, Bouchet C, Nace L, Raffy F, Gaconnet N. Parenteral with enteral nutrition in the critically ill. Intensive Care Med. 2000 Jul;26(7):893-900. doi: 10.1007/s001340051278.
Results Reference
background
PubMed Identifier
18210092
Citation
Desachy A, Clavel M, Vuagnat A, Normand S, Gissot V, Francois B. Initial efficacy and tolerability of early enteral nutrition with immediate or gradual introduction in intubated patients. Intensive Care Med. 2008 Jun;34(6):1054-9. doi: 10.1007/s00134-007-0983-6. Epub 2008 Jan 22.
Results Reference
background
PubMed Identifier
21270385
Citation
Arabi YM, Tamim HM, Dhar GS, Al-Dawood A, Al-Sultan M, Sakkijha MH, Kahoul SH, Brits R. Permissive underfeeding and intensive insulin therapy in critically ill patients: a randomized controlled trial. Am J Clin Nutr. 2011 Mar;93(3):569-77. doi: 10.3945/ajcn.110.005074. Epub 2011 Jan 26.
Results Reference
background
PubMed Identifier
21714640
Citation
Casaer MP, Mesotten D, Hermans G, Wouters PJ, Schetz M, Meyfroidt G, Van Cromphaut S, Ingels C, Meersseman P, Muller J, Vlasselaers D, Debaveye Y, Desmet L, Dubois J, Van Assche A, Vanderheyden S, Wilmer A, Van den Berghe G. Early versus late parenteral nutrition in critically ill adults. N Engl J Med. 2011 Aug 11;365(6):506-17. doi: 10.1056/NEJMoa1102662. Epub 2011 Jun 29.
Results Reference
background
PubMed Identifier
21242788
Citation
Rice TW, Mogan S, Hays MA, Bernard GR, Jensen GL, Wheeler AP. Randomized trial of initial trophic versus full-energy enteral nutrition in mechanically ventilated patients with acute respiratory failure. Crit Care Med. 2011 May;39(5):967-74. doi: 10.1097/CCM.0b013e31820a905a.
Results Reference
background
PubMed Identifier
21340655
Citation
Singer P, Anbar R, Cohen J, Shapiro H, Shalita-Chesner M, Lev S, Grozovski E, Theilla M, Frishman S, Madar Z. The tight calorie control study (TICACOS): a prospective, randomized, controlled pilot study of nutritional support in critically ill patients. Intensive Care Med. 2011 Apr;37(4):601-9. doi: 10.1007/s00134-011-2146-z. Epub 2011 Feb 22.
Results Reference
background
PubMed Identifier
22307571
Citation
National Heart, Lung, and Blood Institute Acute Respiratory Distress Syndrome (ARDS) Clinical Trials Network; Rice TW, Wheeler AP, Thompson BT, Steingrub J, Hite RD, Moss M, Morris A, Dong N, Rock P. Initial trophic vs full enteral feeding in patients with acute lung injury: the EDEN randomized trial. JAMA. 2012 Feb 22;307(8):795-803. doi: 10.1001/jama.2012.137. Epub 2012 Feb 5.
Results Reference
background
PubMed Identifier
23689848
Citation
Doig GS, Simpson F, Sweetman EA, Finfer SR, Cooper DJ, Heighes PT, Davies AR, O'Leary M, Solano T, Peake S; Early PN Investigators of the ANZICS Clinical Trials Group. Early parenteral nutrition in critically ill patients with short-term relative contraindications to early enteral nutrition: a randomized controlled trial. JAMA. 2013 May 22;309(20):2130-8. doi: 10.1001/jama.2013.5124.
Results Reference
background
PubMed Identifier
23218813
Citation
Heidegger CP, Berger MM, Graf S, Zingg W, Darmon P, Costanza MC, Thibault R, Pichard C. Optimisation of energy provision with supplemental parenteral nutrition in critically ill patients: a randomised controlled clinical trial. Lancet. 2013 Feb 2;381(9864):385-93. doi: 10.1016/S0140-6736(12)61351-8. Epub 2012 Dec 3.
Results Reference
background
PubMed Identifier
24722769
Citation
Braunschweig CA, Sheean PM, Peterson SJ, Gomez Perez S, Freels S, Lateef O, Gurka D, Fantuzzi G. Intensive nutrition in acute lung injury: a clinical trial (INTACT). JPEN J Parenter Enteral Nutr. 2015 Jan;39(1):13-20. doi: 10.1177/0148607114528541. Epub 2014 Apr 9.
Results Reference
background
PubMed Identifier
25332331
Citation
Charles EJ, Petroze RT, Metzger R, Hranjec T, Rosenberger LH, Riccio LM, McLeod MD, Guidry CA, Stukenborg GJ, Swenson BR, Willcutts KF, O'Donnell KB, Sawyer RG. Hypocaloric compared with eucaloric nutritional support and its effect on infection rates in a surgical intensive care unit: a randomized controlled trial. Am J Clin Nutr. 2014 Nov;100(5):1337-43. doi: 10.3945/ajcn.114.088609. Epub 2014 Sep 3.
Results Reference
background
PubMed Identifier
24990423
Citation
Peake SL, Davies AR, Deane AM, Lange K, Moran JL, O'Connor SN, Ridley EJ, Williams PJ, Chapman MJ; TARGET investigators and the Australian and New Zealand Intensive Care Society Clinical Trials Group. Use of a concentrated enteral nutrition solution to increase calorie delivery to critically ill patients: a randomized, double-blind, clinical trial. Am J Clin Nutr. 2014 Aug;100(2):616-25. doi: 10.3945/ajcn.114.086322. Epub 2014 Jul 2.
Results Reference
background
PubMed Identifier
24699555
Citation
Petros S, Horbach M, Seidel F, Weidhase L. Hypocaloric vs Normocaloric Nutrition in Critically Ill Patients: A Prospective Randomized Pilot Trial. JPEN J Parenter Enteral Nutr. 2016 Feb;40(2):242-9. doi: 10.1177/0148607114528980. Epub 2014 Apr 3.
Results Reference
background
PubMed Identifier
34775223
Citation
Zhang L, Liu Y, Gao X, Zhou D, Zhang Y, Tian F, Gao T, Wang Y, Chen Z, Lian B, Hu H, Jia Z, Xue Z, Guo D, Zhou J, Gu Y, Gong F, Wu X, Tang Y, Li M, Jin G, Qin H, Yu J, Zhou Y, Chi Q, Yang H, Wang K, Li G, Li N, van Zanten ARH, Li J, Wang X. Immediate vs. gradual advancement to goal of enteral nutrition after elective abdominal surgery: A multicenter non-inferiority randomized trial. Clin Nutr. 2021 Dec;40(12):5802-5811. doi: 10.1016/j.clnu.2021.10.014. Epub 2021 Oct 30.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs