Early Versus Delayed Parenteral Nutrition in Abdominal Surgical Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Early Versus Delayed Parenteral Nutrition in Abdominal Surgical Patients With Nutritional Risk and Initial Enteral Nutrition Intolerance: A Clinical Randomized Trial

Conditions
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Digestive System Neoplasms

Intervention / Treatment
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* Other: Parenteral Nutrition


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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 Life expectancy less than 24 hours of dying patients Refractory shock to meet any of the following article The infusion rate of dopamine > 15 ug/kg/min The infusion rate of dobutamine > 15 ug/kg/min The infusion rate of epinephrine and norepinephrine > 30 ug/min The infusion rate of phenylephrine > 50 ug/min The infusion rate of milrinone > 0.5 ug/kg/min The infusion rate of vasopressin > 0.04 U/min Inter aortic ballon pump (IABP) Hepatic insufficiency (alanine/aspartate transaminase 200% above normal range) Renal insufficiency(creatinine 200% above normal range) Metabolic diseases（hyperthyroidism/ hypothyroidism, adrenal cortex disorders) EN can reach 30% of target energy in 48 hours after surgery Burn area exceeding 20% of the patient's body surface Autoimmune diseases or immune dysfunction or history of organ transplantation International standardization ratio (INR) more than 3.0 or platelet count < 30000 cells/mm3 or other hemorrhagic diathesis Intracranial hemorrhage one month before enrolment General contraindications to infusion therapy or history of severe allergy against ingredients of enteral and parenteral nutrition Has already participated in another clinical trial Has started to nutritional support therapy before enrolment Diabetes mellitus (anamnestic and/or under medical treatment)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early PN<br>Patients who can not tolerate 30% of target energy EN will receive supplemental parenteral nutrition at day 3 after abdominal surgery. | Other: Parenteral Nutrition<br>* 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.<br>|
| Experimental: Delayed PN<br>Patients who can not tolerate 30% of target energy EN will receive supplemental parenteral nutrition at day 8 after abdominal surgery. | Other: Parenteral Nutrition<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of stay in hospital | The length of patients stay in hospital after operation | From date of operation until the date of patients discharged from hospital, assessed up to 12 months. | 
| 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. | 
| Scale the frequency of gastrointestinal intolerance | Diarrhea, vomiting, abdominal distention or cramping and abdominal pain | During the intervention, assessed up to 2 months. | 
| Scale actual calories intake | The total energy patients received during the intervention | During the intervention, assessed up to 2 months. | 
| Laboratory examination | Albumin, pre-albumin, transferrin and retinol conjugated protein | At the date of patients enrollment and after intervention, assessed up to 2 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parenteral Nutrition, Digestive System Neoplasms, Randomized Controlled Trials, Clinical Outcomes, Postoperative Period