NCT03117348

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
411

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2017

Completed
16 days until next milestone

Study Start

First participant enrolled

April 15, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 17, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 24, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 16, 2019

Completed
Last Updated

September 22, 2020

Status Verified

September 1, 2020

Enrollment Period

1.7 years

First QC Date

March 30, 2017

Last Update Submit

September 21, 2020

Conditions

Enteral NutritionPostoperative PeriodDigestive System Neoplasms

Keywords

Enteral NutritionDigestive System NeoplasmsRandomized Controlled TrialClinical Outcomes

Outcome Measures

Primary Outcomes (1)

  • Morbidity of infection

    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 Outcomes (5)

  • Actual calories intake

    During the intervention, assessed up to 2 months.

  • Scale the frequency of gastrointestinal intolerance

    During the intervention, assessed up to 2 months.

  • Laboratory examination

    At the date of patients enrollment and after intervention, assessed up to 2 months.

  • Length of stay in hospital

    From date of operation until the date of patients discharged from hospital, assessed up to 12 months.

  • Mortality

    From date of randomization until the date of death, assessed up to 2 months after patients discharged from hospital.

Study Arms (2)

Gradual goal-dose EN

EXPERIMENTAL

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

Immediate goal-dose EN

EXPERIMENTAL

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

Interventions

Enteral nutritionOTHER

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.

Gradual goal-dose ENImmediate goal-dose EN

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +21 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jinling Hospital, China

Nanjing, Jiangsu, 210002, China

Location

Related Publications (16)

  • 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.

    PMID: 10990103BACKGROUND

  • 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.

    PMID: 18210092BACKGROUND

  • 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.

    PMID: 21270385BACKGROUND

  • 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.

    PMID: 21714640BACKGROUND

  • 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.

    PMID: 21242788BACKGROUND

  • 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.

    PMID: 21340655BACKGROUND

  • 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.

    PMID: 22307571BACKGROUND

  • 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.

    PMID: 23689848BACKGROUND

  • 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.

    PMID: 23218813BACKGROUND

  • 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.

    PMID: 24722769BACKGROUND

  • 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.

    PMID: 25332331BACKGROUND

  • 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.

    PMID: 24990423BACKGROUND

  • 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.

    PMID: 24699555BACKGROUND

  • Gao X, Zhang Y, Qi X, Xiao Y, Gao T, Jin G, Wang K, Zhou Y, Chi Q, Yang H, Li M, Yu J, Qin H, Tang Y, Wu X, Li G, Zhang L, Wang X. Early enteral nutrition versus early supplemental parenteral nutrition in patients undergoing major abdominal surgery: a secondary analysis of 2 randomized clinical trials. Am J Clin Nutr. 2024 Apr;119(4):1036-1043. doi: 10.1016/j.ajcnut.2024.02.006. Epub 2024 Feb 17.

    PMID: 38369126DERIVED

  • Gao X, Zhang L, Zhang Y, Zhou D, Gao T, Liu Y, Jin G, Wang K, Zhou Y, Chi Q, Yang H, Li M, Yu J, Qin H, Tang Y, Wu X, Li G, Wang X. Effect of early achievement of energy target by different nutritional support strategies on nosocomial infections in patients undergoing major abdominal surgery: a secondary analysis of two randomized clinical trials. Int J Surg. 2023 Sep 1;109(9):2680-2688. doi: 10.1097/JS9.0000000000000526.

    PMID: 37300882DERIVED

  • 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.

    PMID: 34775223DERIVED

MeSH Terms

Conditions

Digestive System Neoplasms

Interventions

Enteral Nutrition

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsDigestive System Diseases

Intervention Hierarchy (Ancestors)

Feeding MethodsTherapeuticsNutritional SupportNutrition Therapy

Study Officials

  • Xinying Wang, MD

    Jinling Hospital, China

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 30, 2017

First Posted

April 17, 2017

Study Start

April 15, 2017

Primary Completion

December 24, 2018

Study Completion

February 16, 2019

Last Updated

September 22, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)