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

Enteral Nutrition Clinical Trial

— GIGENAS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03117348
• Other study ID #: 201502022-21
• Status: Completed
• Phase: N/A
• Start date: April 15, 2017
• Est. completion date: February 16, 2019

Study information

• Verified date: September 2020
• Source: Jinling Hospital, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 411
• Est. completion date: February 16, 2019
• Est. primary completion date: December 24, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Digestive System Neoplasms
• Enteral Nutrition
• Gastrointestinal Neoplasms
• Postoperative Period

Intervention

Other:
• 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.

Locations

Country	Name	City	State
China	Jinling Hospital, China	Nanjing	Jiangsu

Sponsors (13)

Lead Sponsor

Collaborator

Jinling Hospital, China

Changhai Hospital, Chinese PLA General Hospital, 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 First Affiliated Hospital of Kunming Medical College, The Second Affiliated Hospital of Harbin Medical University, West China Hospital, Xijing Hospital, Xinqiao Hospital of Chongqing

Country where clinical trial is conducted

China, 

References & Publications (13)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Desachy A, Clavel M, Vuagnat A, Normand S, Gissot V, François 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Actual calories intake	The total energy patients received during the intervention.	During the intervention, assessed up to 2 months.
Secondary	Scale the frequency of gastrointestinal intolerance	Diarrhea, vomiting, abdominal distention or cramping and abdominal pain.	During the intervention, assessed up to 2 months.
Secondary	Laboratory examination	Albumin, pre-albumin, transferrin and retinol conjugated protein	At the date of patients enrollment and after intervention, assessed up to 2 months.
Secondary	Length of stay in hospital	The length of patients stay in hospital	From date of operation until the date of patients discharged from hospital, assessed up to 12 months.
Secondary	Mortality	All deaths reported in all enrolled patients.	From date of randomization until the date of death, assessed up to 2 months after patients discharged from hospital.