Early Versus Delayed Parenteral Nutrition in Abdominal Surgical Patients

NCT03115957 | Completed DMC

• 1 other identifier: 201502022-22
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 1

Brief Summary

Patients will be randomized to early PN group or late PN group at day 3 after abdominal surgery. Patients will receive supplemental parenteral nutrition or not within 7 days after abdominal surgery. Both groups will receive SPN except 80% of target energy delivered by EN or oral or patients are discharged from hospital. The primary and secondary outcomes will be collected.

Conditions

Digestive System Neoplasms

Keywords

Parenteral Nutrition; Digestive System Neoplasms; Randomized Controlled Trials; Clinical Outcomes; Postoperative Period

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)

• 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.

• Scale the frequency of gastrointestinal intolerance

  During the intervention, assessed up to 2 months.

• Scale actual calories intake

  During the intervention, assessed up to 2 months.

• Laboratory examination

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

Study Arms (2)

Early PN

EXPERIMENTAL

Patients who can not tolerate 30% of target energy EN will receive supplemental parenteral nutrition at day 3 after abdominal surgery.

Other: Parenteral Nutrition

Delayed PN

EXPERIMENTAL

Patients who can not tolerate 30% of target energy EN will receive supplemental parenteral nutrition at day 8 after abdominal surgery.

Other: Parenteral Nutrition

Interventions

Parenteral Nutrition OTHER

Patients who can not tolerate 30% of target energy EN will receive supplemental parenteral nutrition at day 3 or at day 8 after abdominal surgery.

Delayed PN; Early PN

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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
• 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

Sponsors & Collaborators

• Jinling Hospital, China: lead
• Peking Union Medical College Hospital: collaborator
• Chinese PLA General Hospital: collaborator
• First Affiliated Hospital, Sun Yat-Sen University: collaborator
• Xijing Hospital: collaborator
• West China Hospital: collaborator
• Xinqiao Hospital of Chongqing: collaborator
• Second Affiliated Hospital, School of Medicine, Zhejiang University: collaborator
• Changhai Hospital: collaborator
• Shanghai 10th People's Hospital: collaborator
• The Second Affiliated Hospital of Harbin Medical University: collaborator
• The Affiliated Hospital of Qingdao University: collaborator
• First Affiliated Hospital of Kunming Medical University: collaborator

Study Sites (1)

JinlingH

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: 10990103 BACKGROUND

• 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: 18210092 BACKGROUND

• 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: 21270385 BACKGROUND

• 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: 21714640 BACKGROUND

• 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: 21242788 BACKGROUND

• 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: 21340655 BACKGROUND

• 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: 22307571 BACKGROUND

• 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: 23689848 BACKGROUND

• 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: 23218813 BACKGROUND

• 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: 24722769 BACKGROUND

• 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: 25332331 BACKGROUND

• 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: 24990423 BACKGROUND

• 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: 24699555 BACKGROUND

• 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: 38369126 DERIVED

• 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: 37300882 DERIVED

• Gao X, Liu Y, Zhang L, Zhou D, Tian F, Gao T, Tian H, Hu H, Gong F, Guo D, Zhou J, Gu Y, Lian B, Xue Z, Jia Z, Chen Z, Wang Y, Jin G, Wang K, Zhou Y, Chi Q, Yang H, Li M, Yu J, Qin H, Tang Y, Wu X, Li G, Li N, Li J, Pichard C, Wang X. Effect of Early vs Late Supplemental Parenteral Nutrition in Patients Undergoing Abdominal Surgery: A Randomized Clinical Trial. JAMA Surg. 2022 May 1;157(5):384-393. doi: 10.1001/jamasurg.2022.0269.

  PMID: 35293973 DERIVED

MeSH Terms

Conditions

Digestive System Neoplasms; Hyperphagia

Interventions

Parenteral Nutrition

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Feeding Methods; Therapeutics; Nutritional Support; Nutrition 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, Chief of Clinical Nutrition Service

Study Record Dates

• First Submitted: March 30, 2017
• First Posted: April 14, 2017
• Study Start: April 14, 2017
• Primary Completion: December 30, 2018
• Study Completion: February 22, 2019
• Last Updated: September 29, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)