Clinical trial · Interventional
Early Versus Delayed Parenteral Nutrition in Abdominal Surgical Patients
Early Versus Delayed Parenteral Nutrition in Abdominal Surgical Patients With Nutritional Risk and Initial Enteral Nutrition Intolerance: A Clinical Randomized Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Digestive System Neoplasms | Digestive System Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Parenteral Nutrition | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Early PN
- description
- Patients who can not tolerate 30% of target energy EN will receive supplemental parenteral nutrition at day 3 after abdominal surgery.
- interventionNames
- Other: Parenteral Nutrition
- type
- EXPERIMENTAL
- label
- Delayed PN
- description
- Patients who can not tolerate 30% of target energy EN will receive supplemental parenteral nutrition at day 8 after abdominal surgery.
- interventionNames
- Other: Parenteral Nutrition
Primary outcomes (1)
- measure
- Morbidity of infection
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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 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 200% above normal range) 10. Renal insufficiency(creatinine 200% above normal range) 11. Metabolic diseases(hyperthyroidism/ hypothyroidism, adrenal cortex disorders) 12. EN can 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)
References
Publications (17)
- BACKGROUNDBauer 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
- BACKGROUNDDesachy 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
- BACKGROUNDArabi 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
- BACKGROUNDCasaer 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
- BACKGROUNDRice 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
- BACKGROUNDSinger 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