Digestive System Neoplasms
Conditions
Keywords
Parenteral Nutrition, Digestive System Neoplasms, Randomized Controlled Trials, Clinical Outcomes, Postoperative Period
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.
Detailed description
Patients after abdominal surgery will attempt enteral nutrition support for 2 days, if she/he can not tolerate 30% of target energy, then she/he will be randomized to early PN group or late PN group at day 3. Patients in early PN group will receive supplemental parenteral nutrition at day 3 while patients in late PN group will not receive supplemental parenteral nutrition until day 8 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.
Interventions
OTHERParenteral Nutrition
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.
Sponsors
Peking Union Medical College Hospital
Chinese PLA General Hospital
First Affiliated Hospital, Sun Yat-Sen University
Xijing Hospital
West China Hospital
Xinqiao Hospital of Chongqing
Second Affiliated Hospital, School of Medicine, Zhejiang University
Changhai Hospital
Shanghai 10th People's Hospital
The Second Affiliated Hospital of Harbin Medical University
The Affiliated Hospital of Qingdao University
First Affiliated Hospital of Kunming Medical University
Jinling Hospital, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Morbidity of infection | From date of randomization until the date of infection from any cause, assessed up to 2 months. | Invasion of the host organism by microorganisms that can cause pathological conditions or diseases |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of stay in hospital | From date of operation until the date of patients discharged from hospital, assessed up to 12 months. | The length of patients stay in hospital after operation |
| Mortality | From date of randomization until the date of death, assessed up to 2 months after patients discharged from hospital. | All deaths reported in all enrolled patients. |
| Scale the frequency of gastrointestinal intolerance | During the intervention, assessed up to 2 months. | Diarrhea, vomiting, abdominal distention or cramping and abdominal pain |
| Scale actual calories intake | During the intervention, assessed up to 2 months. | The total energy patients received during the intervention |
| Laboratory examination | At the date of patients enrollment and after intervention, assessed up to 2 months. | Albumin, pre-albumin, transferrin and retinol conjugated protein |
Countries
China
Outcome results
None listed