Early Versus Delayed Parenteral Nutrition in Abdominal Surgical Patients

Jinling Hospital, China230 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

230

Conditions

Digestive System Neoplasms

Interventions

Parenteral NutritionOTHER

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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)

Locations (1)

JinlingH

Nanjing, Jiangsu, China

Outcomes

Primary Outcomes

Morbidity of infection

Invasion of the host organism by microorganisms that can cause pathological conditions or diseases

Time frame: From date of randomization until the date of infection from any cause, assessed up to 2 months.

Secondary Outcomes

Length of stay in hospital

The length of patients stay in hospital after operation

Time frame: 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.

Time frame: 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

Time frame: During the intervention, assessed up to 2 months.

Scale actual calories intake

The total energy patients received during the intervention

Time frame: During the intervention, assessed up to 2 months.

Laboratory examination

Albumin, pre-albumin, transferrin and retinol conjugated protein

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

Data from ClinicalTrials.gov

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