PNASIT: Early Versus Delayed Parenteral Nutrition in Abdominal Surgical Patients

Sponsor

Jinling Hospital, China (Other)

Overall Status

Completed

CT.gov ID

NCT03115957

Collaborator

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

230

Enrollment

Location

Arms

22.3

Actual Duration (Months)

10.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Digestive System Neoplasms	Other: Parenteral Nutrition	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

230 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 14, 2017

Actual Primary Completion Date :

Dec 30, 2018

Actual Study Completion Date :

Feb 22, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Early PN Patients who can not tolerate 30% of target energy EN will receive supplemental parenteral nutrition at day 3 after abdominal surgery.	Other: Parenteral 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.
Experimental: Delayed PN Patients who can not tolerate 30% of target energy EN will receive supplemental parenteral nutrition at day 8 after abdominal surgery.	Other: Parenteral 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.

Arm

Intervention/Treatment

Experimental: Early PN

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

Other: Parenteral 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.

Experimental: Delayed PN

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

Other: Parenteral 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.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)