Gradual Versus Immediate Goal-dose Enteral Nutrition in Abdominal Surgery Patients
NCT ID: NCT03117348
Last Updated: 2020-09-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
411 participants
INTERVENTIONAL
2017-04-15
2019-02-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
2. patients undergoing selective operation without trauma
3. patients following medium or major abdominal surgery
4. NRS 2002≥ 3
Exclusion Criteria
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)
18 Years
80 Years
ALL
No
Sponsors
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Peking Union Medical College Hospital
OTHER
Chinese PLA General Hospital
OTHER
First Affiliated Hospital, Sun Yat-Sen University
OTHER
Xijing Hospital
OTHER
West China Hospital
OTHER
Xinqiao Hospital of Chongqing
OTHER
Second Affiliated Hospital, School of Medicine, Zhejiang University
OTHER
Changhai Hospital
OTHER
Shanghai 10th People's Hospital
OTHER
The Second Affiliated Hospital of Harbin Medical University
OTHER
The Affiliated Hospital of Qingdao University
OTHER
First Affiliated Hospital of Kunming Medical University
OTHER
Jinling Hospital, China
OTHER
Responsible Party
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Wang Xinying
Professor
Principal Investigators
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Xinying Wang, MD
Role: PRINCIPAL_INVESTIGATOR
Jinling Hospital, China
Locations
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Jinling Hospital, China
Nanjing, Jiangsu, China
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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201502022-21
Identifier Type: -
Identifier Source: org_study_id
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