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Trial record 3 of 13 for:    24108501 [PUBMED-IDS]

Influence of Early vs Late SPN on Long-term Quality of Life in ICU Patients After Gastrointestinal Oncological Surgery (hELPLiNe)

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ClinicalTrials.gov Identifier: NCT03699371
Recruitment Status : Not yet recruiting
First Posted : October 8, 2018
Last Update Posted : October 12, 2018
Sponsor:
Collaborator:
Uniwersytecki Szpital Kliniczny w Opolu
Information provided by (Responsible Party):
Paweł Piwowarczyk, Medical University of Lublin

Brief Summary:

BACKGROUND: Nutrition plays a significant role in ICU treatment, and may influence mortality and length of stay in ICU. Enteral route (EN) is preferential to parenteral route (PN) in provision of daily nutritional requirements. When enteral route is insufficient, supplemental parenteral nutrition (SPN) is recommended. Optimal timing of SPN in acute phase of illness remains elusive. ICU patients suffer significant lean body mass loss, in majority, in the first 7-10 days of stay. Optimal provision of protein may prevent muscle wasting. Lean body mass is essential for optimal physical functioning after treatment. Although ICU mortality has been reduced lately, the number of patients going to rehabilitation after ICU stay has tripled. Patients after oncological surgery of the gastrointestinal tract may be threatened with impairment of physical functioning after ICU treatment.

AIM: To compare the influence of early and late supplemental parenteral nutrition on long-term physical functioning in ICU patients after oncological surgery of the gastrointestinal tract.

STUDY DESIGN: Prospective, randomised, multi-centre assessor-blinded study. METHODS & ANALYSIS: Patients will be randomised into intervention group that would receive SPN on first day, and would be continued until 7th day of stay in ICU. Control group would receive SPN on 7th day of stay in ICU, when it is not then already met via enteral route. Physical Component of SF-36 Scale at 6 month after ICU admission will be assessed.


Condition or disease Intervention/treatment Phase
Nutrition Aspect of Cancer Procedure: Early Supplemental Parenteral Nutrition Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: prospective, randomised, multi-centre assessor-blinded study
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Influence of Early vs Late Supplemental ParenteraL Nutrition on Long-term Quality of Life in ICU Patients After Gastrointestinal Oncological Surgery. A Prospective, Randomised, Multi-centre Assessor-blinded Study. hELPLiNe Trial
Estimated Study Start Date : November 1, 2018
Estimated Primary Completion Date : November 1, 2020
Estimated Study Completion Date : May 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Early Supplemental Parenteral Nutrition
Intervention group: would receive EN reaching up to 20 % of daily nutritional requirements and early (on first day of stay in ICU) provision (of up to 80%) of protein (2 g/kg/ day or in case of continuous renal replacement therapy (CRRT) 2,5 g/kg/ day) and caloric (15-20 kcal/kg/day) needs in SPN that would be continued until 7th day of stay in ICU for the purpose of the study.
Procedure: Early Supplemental Parenteral Nutrition
Intervention group: would receive EN reaching up to 20 % of daily nutritional requirements and early (on first day of stay in ICU) provision (of up to 80%) of protein (2 g/kg/ day or in case of CRRT 2,5 g/kg/ day) and caloric (15-20 kcal/kg/day) needs in SPN that would be continued until 7th day of stay in ICU. Central venous catheter placement would not be assessed as a part of intervention due to the fact that it is a part of routine medical activities performed during admission to ICU.

No Intervention: Late Supplemental Parenteral Nutrition
Control group: would receive EN reaching up to 20 % of daily nutritional requirements and late (of up to 80%) of protein (2 g/kg/ day or in case of CRRT 2,5 g/kg/ day) and caloric (15-20 kcal/kg/day ) in SPN on 7th day of stay in ICU if it is not already met via enteral route.



Primary Outcome Measures :
  1. Long-term quality of life at 3 months [ Time Frame: Physical component of 36 -SF questionnaire at 3 months after admission to ICU ]
    Long-term quality of life measured in physical component of 36 -SF questionnaire

  2. Long-term quality of life at 6 months [ Time Frame: Physical component of 36 -SF questionnaire at 6 months after admission to ICU ]
    Long-term quality of life measured in physical component of 36 -SF questionnaire


Secondary Outcome Measures :
  1. Enteral route intolerance [ Time Frame: At day 3 since admission to ICU ]
    Inability to administer up to 60% of protein needs on 3rd day via enteral route

  2. Thickness of diaphragm [ Time Frame: 1st, 3rd, 5th day of ICU stay ]
    Change from baseline in ultrasound measured thickness of diaphragm

  3. Protein delivery [ Time Frame: For 7 days since admission to ICU ]
    Protein delivery defined as daily input of proteins via SPN

  4. Energy Intake [ Time Frame: For 7 days since admission to ICU ]
    Energy delivery defined as daily input of calories via SPN

  5. Insulin dose [ Time Frame: For 7 days since admission to ICU ]
    Insulin dose defined as summary daily input of insulin

  6. Blood glucose profile [ Time Frame: For 7 days since admission to ICU ]
    Blood glucose profile defined as mean daily glucose level

  7. Organic phosphorus level [ Time Frame: For 7 days since admission to ICU ]
    Organic phosphorus level defined as result in blood test performed daily

  8. Sequential Organ Failure Assessment score ( SOFA score) [ Time Frame: For 28 days since admission to ICU or till discharge ]
    We will collect data regarding changes from baseline SOFA score - to determine the extent of a person's organ function failure. SOFA scoring system is useful in predicting the clinical outcomes of critically ill patients. Patient can be scored from 0 to 24. If the patient is scored 0 than the patient is in a good state and predicted mortality is low, while 24 is the worst result with expected very high mortality rate.

  9. Mechanical Ventilation [ Time Frame: For 28 days since admission to ICU or till discharge ]
    Numbers of days of mechanical ventilation

  10. Length of stay in the ICU [ Time Frame: For 28 days since admission to ICU or till discharge ]
    Numbers of days of patient stay in ICU

  11. ICU mortality [ Time Frame: For 28 days since admission to ICU or till discharge ]
  12. Hospital mortality [ Time Frame: For 28 days since admission to ICU or till discharge ]
  13. Length of stay in hospital [ Time Frame: For 28 days since admission to ICU or till discharge ]
    Numbers of days of patient stay in hospital

  14. Health-care associated infection [ Time Frame: For 28 days since admission to ICU or till discharge ]
    New onset of health-care associated infection

  15. Antibiotic-free days [ Time Frame: For 28 days since admission to ICU or till discharge ]
    Number of days patient was not given the antibiotics


Other Outcome Measures:
  1. PCS SF-36 change [ Time Frame: From enrollment till 6 months assessment ]
    Change from baseline in PCS SF-36



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. ICU patients in the acute phase of critical illness after gastrointestinal oncological surgery.
  2. Admitted to the ICU during the previous 24 hours with a minimum expected ICU stay of ≥5 days
  3. Central venous access available for continuous infusion of the study drugs
  4. Sequential Organ Failure Assessment (SOFA) score ≥2
  5. Written informed consent from the patient or the patient's legal representative

Exclusion Criteria:

Contraindication against SPN or inability to receive SPN via central venous access

  1. Received PN within 7 days before randomisation
  2. Expected to receive ≥20% of energy via supplemental enteral nutrition (EN) and/or non-nutritional sources (e.g. glucose solution for drug dilution or lipids from propofol) during the first 3 nutritional treatment days
  3. Inability to initiate EN prior to randomization
  4. Body mass index (BMI) <17 kg/m2 or >35 kg/m2
  5. Any severe, persistent blood coagulation disorder with uncontrolled bleeding
  6. Any congenital errors of amino acid metabolism
  7. Known hypersensitivity to fish, egg, soybean proteins, peanut proteins, or to any of the active substances or excipients contained in SPN.
  8. Known hypersensitivity to milk protein or to any other substance contained in SPN
  9. Acute liver failure with encephalopathy, including intoxication (e.g. paracetamol, death cap, golden chain) and/or liver enzymes (aspartate aminotransferase [AST], alanine aminotransferase [ALT], gamma glutamyl transferase [GGT]) or bilirubin exceeding 10 x ULN
  10. Hemophagocytic syndrome
  11. Known history of human immunodeficiency virus (HIV), hepatitis B and/or C
  12. Pregnancy or lactation
  13. Patient unlikely to survive to 6 months due to underlying illness
  14. Receiving end-of-life-care

    Laboratory Exclusions:

  15. Hypertriglyceridemia characterised by serum triglyceride levels >4 mmol/L [>350 mg/dL])
  16. Treatment-refractory, clinically significant major abnormality in the serum concentration of any electrolyte (sodium, potassium, magnesium, total calcium, chloride, inorganic phosphate)

    Concomitant Therapy Exclusions:

  17. Chronic maintenance therapy with systemic glucocorticoid steroids (Hydrocortisone >0.3 mg/kg/d)
  18. Concomitant administration of chemotherapy
  19. Administration of growth hormone and teduglutide within the previous 4 weeks

    Other Exclusions:

  20. Chronic liver failure ( Child -Pugh scale B or C) e.g. secondary to drug or alcohol abuse
  21. Participation in another interventional clinical trial within the previous 4 weeks
  22. Previous inclusion in the present study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03699371


Contacts
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Contact: Paweł Piwowarczyk, MD PhD 815372713 ext +48 piwowarczyk.pawel@gmail.com

Locations
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Poland
2nd Department of Anesthesiology and Critical Care, Medical University of Lublin Not yet recruiting
Lublin, Lubelskie, Poland, 20-059
Contact: Paweł Piwowarczyk, MD PhD    511285352 ext +48    piwowarczyk.pawel@gmail.com   
Sub-Investigator: Mirosław Czuczwar, MD PhD         
Sub-Investigator: Michał Borys, MD PhD         
Department of Anesthesiology and Intensive Care, Uniwersytecki Szpital Kliniczny w Opolu
Opole, Silesia, Poland, 45-401
Sponsors and Collaborators
Medical University of Lublin
Uniwersytecki Szpital Kliniczny w Opolu
Investigators
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Principal Investigator: Paweł Piwowarczyk, MD PhD Medical University in Lublin

Publications:
Reignier J, Boisramé-Helms J, Brisard L, Lascarrou JB, Ait Hssain A, Anguel N, Argaud L, Asehnoune K, Asfar P, Bellec F, Botoc V, Bretagnol A, Bui HN, Canet E, Da Silva D, Darmon M, Das V, Devaquet J, Djibre M, Ganster F, Garrouste-Orgeas M, Gaudry S, Gontier O, Guérin C, Guidet B, Guitton C, Herbrecht JE, Lacherade JC, Letocart P, Martino F, Maxime V, Mercier E, Mira JP, Nseir S, Piton G, Quenot JP, Richecoeur J, Rigaud JP, Robert R, Rolin N, Schwebel C, Sirodot M, Tinturier F, Thévenin D, Giraudeau B, Le Gouge A; NUTRIREA-2 Trial Investigators; Clinical Research in Intensive Care and Sepsis (CRICS) group. Enteral versus parenteral early nutrition in ventilated adults with shock: a randomised, controlled, multicentre, open-label, parallel-group study (NUTRIREA-2). Lancet. 2018 Jan 13;391(10116):133-143. doi: 10.1016/S0140-6736(17)32146-3. Epub 2017 Nov 8.

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Responsible Party: Paweł Piwowarczyk, Principal Investigator, Medical University of Lublin
ClinicalTrials.gov Identifier: NCT03699371     History of Changes
Other Study ID Numbers: KE-0254/152/2018
First Posted: October 8, 2018    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Paweł Piwowarczyk, Medical University of Lublin:
early parenteral nutrition
supplemental nutrition
quality of life
oncological surgery
critical care