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Completed

NCT Number: NCT03115957

Early Versus Delayed Parenteral Nutrition in Abdominal Surgical Patients

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

JinlingH

Nanjing, Jiangsu, 210002, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Parenteral nutrition

Other

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.

Primary outcomes

  1. Morbidity of infection

    Time frame: 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 outcomes

  1. Length of stay in hospital

    Time frame: 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

  2. Mortality

    Time frame: 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.

  3. Scale the frequency of gastrointestinal intolerance

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

    Diarrhea, vomiting, abdominal distention or cramping and abdominal pain

  4. Scale actual calories intake

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

    The total energy patients received during the intervention

  5. Laboratory examination

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

    Albumin, pre-albumin, transferrin and retinol conjugated protein

Sponsors and collaborators

Lead sponsor

Jinling Hospital, China

Other

Collaborators

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

Registry information

Official study title

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

Acronym: PNASIT

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Apr 14, 2017
Registry last updated
Sep 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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