- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03115957
Early Versus Delayed Parenteral Nutrition in Abdominal Surgical Patients (PNASIT)
September 26, 2020 updated by: Wang Xinying, Jinling Hospital, China
Early Versus Delayed Parenteral Nutrition in Abdominal Surgical Patients With Nutritional Risk and Initial Enteral Nutrition Intolerance: A Clinical Randomized Trial
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
230
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Jiangsu
-
Nanjing, Jiangsu, China, 210002
- JinlingH
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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 |
---|---|---|
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
|
At the date of patients enrollment and after intervention, assessed up to 2 months.
|
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.
|
From date of randomization until the date of death, assessed up to 2 months after patients discharged from hospital.
|
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
|
From date of operation until the date of patients discharged from hospital, assessed up to 12 months.
|
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
|
During the intervention, assessed up to 2 months.
|
Scale actual calories intake
Time Frame: During the intervention, assessed up to 2 months.
|
The total energy patients received during the intervention
|
During the intervention, assessed up to 2 months.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Xinying Wang, MD, Jinling Hospital, China
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Casaer MP, Mesotten D, Hermans G, Wouters PJ, Schetz M, Meyfroidt G, Van Cromphaut S, Ingels C, Meersseman P, Muller J, Vlasselaers D, Debaveye Y, Desmet L, Dubois J, Van Assche A, Vanderheyden S, Wilmer A, Van den Berghe G. Early versus late parenteral nutrition in critically ill adults. N Engl J Med. 2011 Aug 11;365(6):506-17. doi: 10.1056/NEJMoa1102662. Epub 2011 Jun 29.
- Doig GS, Simpson F, Sweetman EA, Finfer SR, Cooper DJ, Heighes PT, Davies AR, O'Leary M, Solano T, Peake S; Early PN Investigators of the ANZICS Clinical Trials Group. Early parenteral nutrition in critically ill patients with short-term relative contraindications to early enteral nutrition: a randomized controlled trial. JAMA. 2013 May 22;309(20):2130-8. doi: 10.1001/jama.2013.5124.
- Singer P, Anbar R, Cohen J, Shapiro H, Shalita-Chesner M, Lev S, Grozovski E, Theilla M, Frishman S, Madar Z. The tight calorie control study (TICACOS): a prospective, randomized, controlled pilot study of nutritional support in critically ill patients. Intensive Care Med. 2011 Apr;37(4):601-9. doi: 10.1007/s00134-011-2146-z. Epub 2011 Feb 22.
- Heidegger CP, Berger MM, Graf S, Zingg W, Darmon P, Costanza MC, Thibault R, Pichard C. Optimisation of energy provision with supplemental parenteral nutrition in critically ill patients: a randomised controlled clinical trial. Lancet. 2013 Feb 2;381(9864):385-93. doi: 10.1016/S0140-6736(12)61351-8. Epub 2012 Dec 3.
- National Heart, Lung, and Blood Institute Acute Respiratory Distress Syndrome (ARDS) Clinical Trials Network; Rice TW, Wheeler AP, Thompson BT, Steingrub J, Hite RD, Moss M, Morris A, Dong N, Rock P. Initial trophic vs full enteral feeding in patients with acute lung injury: the EDEN randomized trial. JAMA. 2012 Feb 22;307(8):795-803. doi: 10.1001/jama.2012.137. Epub 2012 Feb 5.
- Bauer P, Charpentier C, Bouchet C, Nace L, Raffy F, Gaconnet N. Parenteral with enteral nutrition in the critically ill. Intensive Care Med. 2000 Jul;26(7):893-900. doi: 10.1007/s001340051278.
- Desachy A, Clavel M, Vuagnat A, Normand S, Gissot V, Francois B. Initial efficacy and tolerability of early enteral nutrition with immediate or gradual introduction in intubated patients. Intensive Care Med. 2008 Jun;34(6):1054-9. doi: 10.1007/s00134-007-0983-6. Epub 2008 Jan 22.
- Arabi YM, Tamim HM, Dhar GS, Al-Dawood A, Al-Sultan M, Sakkijha MH, Kahoul SH, Brits R. Permissive underfeeding and intensive insulin therapy in critically ill patients: a randomized controlled trial. Am J Clin Nutr. 2011 Mar;93(3):569-77. doi: 10.3945/ajcn.110.005074. Epub 2011 Jan 26.
- Rice TW, Mogan S, Hays MA, Bernard GR, Jensen GL, Wheeler AP. Randomized trial of initial trophic versus full-energy enteral nutrition in mechanically ventilated patients with acute respiratory failure. Crit Care Med. 2011 May;39(5):967-74. doi: 10.1097/CCM.0b013e31820a905a.
- Braunschweig CA, Sheean PM, Peterson SJ, Gomez Perez S, Freels S, Lateef O, Gurka D, Fantuzzi G. Intensive nutrition in acute lung injury: a clinical trial (INTACT). JPEN J Parenter Enteral Nutr. 2015 Jan;39(1):13-20. doi: 10.1177/0148607114528541. Epub 2014 Apr 9.
- Charles EJ, Petroze RT, Metzger R, Hranjec T, Rosenberger LH, Riccio LM, McLeod MD, Guidry CA, Stukenborg GJ, Swenson BR, Willcutts KF, O'Donnell KB, Sawyer RG. Hypocaloric compared with eucaloric nutritional support and its effect on infection rates in a surgical intensive care unit: a randomized controlled trial. Am J Clin Nutr. 2014 Nov;100(5):1337-43. doi: 10.3945/ajcn.114.088609. Epub 2014 Sep 3.
- Peake SL, Davies AR, Deane AM, Lange K, Moran JL, O'Connor SN, Ridley EJ, Williams PJ, Chapman MJ; TARGET investigators and the Australian and New Zealand Intensive Care Society Clinical Trials Group. Use of a concentrated enteral nutrition solution to increase calorie delivery to critically ill patients: a randomized, double-blind, clinical trial. Am J Clin Nutr. 2014 Aug;100(2):616-25. doi: 10.3945/ajcn.114.086322. Epub 2014 Jul 2.
- Petros S, Horbach M, Seidel F, Weidhase L. Hypocaloric vs Normocaloric Nutrition in Critically Ill Patients: A Prospective Randomized Pilot Trial. JPEN J Parenter Enteral Nutr. 2016 Feb;40(2):242-9. doi: 10.1177/0148607114528980. Epub 2014 Apr 3.
- Gao X, Liu Y, Zhang L, Zhou D, Tian F, Gao T, Tian H, Hu H, Gong F, Guo D, Zhou J, Gu Y, Lian B, Xue Z, Jia Z, Chen Z, Wang Y, Jin G, Wang K, Zhou Y, Chi Q, Yang H, Li M, Yu J, Qin H, Tang Y, Wu X, Li G, Li N, Li J, Pichard C, Wang X. Effect of Early vs Late Supplemental Parenteral Nutrition in Patients Undergoing Abdominal Surgery: A Randomized Clinical Trial. JAMA Surg. 2022 May 1;157(5):384-393. doi: 10.1001/jamasurg.2022.0269.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 14, 2017
Primary Completion (Actual)
December 30, 2018
Study Completion (Actual)
February 22, 2019
Study Registration Dates
First Submitted
March 30, 2017
First Submitted That Met QC Criteria
April 13, 2017
First Posted (Actual)
April 14, 2017
Study Record Updates
Last Update Posted (Actual)
September 29, 2020
Last Update Submitted That Met QC Criteria
September 26, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201502022-22
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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