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Enteral NutritionGIGENASNCT03117348

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

A study testing Enteral nutrition in people with Enteral Nutrition and Postoperative Period, run by Jinling Hospital, China at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Enteral nutrition
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
411 participants
Where
1 siteChina
Study dates
15 Apr 2017to 16 Feb 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Psychiatric disorders
  • Pregnancy or breast-feeding women
  • Malnutrition
  • Weight loss >10%-15% in 6 months
  • BMI<18.5
  • SGA score with stage C
Show all 36Show fewer
  • 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)

Trial locations and contacts

1 site in 1 country.

China1 site

  • Jinling Hospital, China

    Nanjing, Jiangsu, 210002

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
Enteral nutrition
Keywords
Enteral Nutrition, Digestive System Neoplasms, Randomized Controlled Trial, Clinical Outcomes
Medical subject headings
Digestive System Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT03117348
Study groupRoleWhat they receive
Gradual goal-dose ENExperimentalPatients 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.
Receives: Other: Enteral nutrition
Immediate goal-dose ENExperimentalPatients in immediate Goal-dose EN group will reach the 100% of target energy by enteral nutrition at day 3 after abdominal surgery.
Receives: Other: Enteral nutrition

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Morbidity of infection

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

    Measured: From date of randomization until the date of infection from any cause, assessed up to 2 months.

Secondary outcomes (5)

  1. Actual calories intake

    The total energy patients received during the intervention.

    Measured: During the intervention, assessed up to 2 months.

  2. Scale the frequency of gastrointestinal intolerance

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

    Measured: During the intervention, assessed up to 2 months.

  3. Laboratory examination

    Albumin, pre-albumin, transferrin and retinol conjugated protein

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

  4. Length of stay in hospital

    The length of patients stay in hospital

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

  5. Mortality

    All deaths reported in all enrolled patients.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Apr 2017
  2. Study start15 Apr 2017
  3. Primary completion24 Dec 2018
  4. Study completion16 Feb 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
411 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03117348
Sponsor's protocol ID
201502022-21
Acronym
GIGENAS
Status last verified
Sep 2020
First submitted
30 Mar 2017
Last updated
22 Sep 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 10990103

  • 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.

    PubMed 18210092

  • 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.

    PubMed 21270385

  • 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.

    PubMed 21714640

  • 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.

    PubMed 21242788

  • 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.

    PubMed 21340655

  • 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.

    PubMed 22307571

  • 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.

    PubMed 23689848

  • 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.

    PubMed 23218813

  • 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.

    PubMed 24722769

  • 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.

    PubMed 25332331

  • 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.

    PubMed 24990423

  • 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.

    PubMed 24699555

  • 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.

    PubMed 38369126

  • 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.

    PubMed 37300882

Questions about this trial

What is this clinical trial studying?

A study testing Enteral nutrition in people with Enteral Nutrition and Postoperative Period, run by Jinling Hospital, China at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Morbidity of infection (time frame: From date of randomization until the date of infection from any cause, assessed up to 2 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03117348, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2020.

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