Clinical trial NCT03699371: Influence of Early vs Late SPN on Long-term Quality of Life in ICU Patients After Gastrointestinal Oncological Surgery
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nutrition Aspect of Cancer
Keywords: early parenteral nutrition
supplemental nutrition
quality of life
oncological surgery
critical care
Lead sponsor: Medical University of Lublin
Sponsor class: OTHER
Collaborators: name: Uniwersytecki Szpital Kliniczny w Opolu
First posted: 2018-10-09
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective, randomised, multi-centre assessor-blinded study
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: Long-term quality of life at 3 months
timeFrame: Physical component of 36 -SF questionnaire at 3 months after admission to ICU
measure: Long-term quality of life at 6 months
timeFrame: Physical component of 36 -SF questionnaire at 6 months after admission to ICU
Secondary outcomes:
measure: Enteral route intolerance
timeFrame: At day 3 since admission to ICU
measure: Thickness of diaphragm
timeFrame: 1st, 3rd, 5th day of ICU stay
measure: Protein delivery
timeFrame: For 7 days since admission to ICU
measure: Energy Intake
timeFrame: For 7 days since admission to ICU
measure: Insulin dose
timeFrame: For 7 days since admission to ICU
measure: Blood glucose profile
timeFrame: For 7 days since admission to ICU
measure: Organic phosphorus level
timeFrame: For 7 days since admission to ICU
measure: Sequential Organ Failure Assessment score ( SOFA score)
timeFrame: For 28 days since admission to ICU or till discharge
measure: Mechanical Ventilation
timeFrame: For 28 days since admission to ICU or till discharge
measure: Length of stay in the ICU
timeFrame: For 28 days since admission to ICU or till discharge
measure: ICU mortality
timeFrame: For 28 days since admission to ICU or till discharge
measure: Hospital mortality
timeFrame: For 28 days since admission to ICU or till discharge
measure: Length of stay in hospital
timeFrame: For 28 days since admission to ICU or till discharge
measure: Health-care associated infection
timeFrame: For 28 days since admission to ICU or till discharge
measure: Antibiotic-free days
timeFrame: For 28 days since admission to ICU or till discharge
Other outcomes:
measure: PCS SF-36 change
timeFrame: From enrollment till 6 months assessment
Locations:
city: Lublin
country: Poland
facility: 2nd Department of Anesthesiology and Critical Care, Medical University of Lublin
state: Lubelskie
city: Opole
country: Poland
facility: Department of Anesthesiology and Intensive Care, Uniwersytecki Szpital Kliniczny w Opolu
state: Silesia
Study officials:
affiliation: Medical University in Lublin
name: Paweł Piwowarczyk, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nicolo M, Heyland DK, Chittams J, Sammarco T, Compher C. Clinical Outcomes Related to Protein Delivery in a Critically Ill Population: A Multicenter, Multinational Observation Study. JPEN J Parenter Enteral Nutr. 2016 Jan;40(1):45-51. doi: 10.1177/0148607115583675. Epub 2015 Apr 21.
citation: Puthucheary ZA, Rawal J, McPhail M, Connolly B, Ratnayake G, Chan P, Hopkinson NS, Phadke R, Dew T, Sidhu PS, Velloso C, Seymour J, Agley CC, Selby A, Limb M, Edwards LM, Smith K, Rowlerson A, Rennie MJ, Moxham J, Harridge SD, Hart N, Montgomery HE. Acute skeletal muscle wasting in critical illness. JAMA. 2013 Oct 16;310(15):1591-600. doi: 10.1001/jama.2013.278481.
citation: Sundstrom Rehal M, Liebau F, Tjader I, Norberg A, Rooyackers O, Wernerman J. A supplemental intravenous amino acid infusion sustains a positive protein balance for 24 hours in critically ill patients. Crit Care. 2017 Dec 6;21(1):298. doi: 10.1186/s13054-017-1892-x.
citation: Arends J, Bachmann P, Baracos V, Barthelemy N, Bertz H, Bozzetti F, Fearon K, Hutterer E, Isenring E, Kaasa S, Krznaric Z, Laird B, Larsson M, Laviano A, Muhlebach S, Muscaritoli M, Oldervoll L, Ravasco P, Solheim T, Strasser F, de van der Schueren M, Preiser JC. ESPEN guidelines on nutrition in cancer patients. Clin Nutr. 2017 Feb;36(1):11-48. doi: 10.1016/j.clnu.2016.07.015. Epub 2016 Aug 6.
citation: Allingstrup MJ, Kondrup J, Wiis J, Claudius C, Pedersen UG, Hein-Rasmussen R, Bjerregaard MR, Steensen M, Jensen TH, Lange T, Madsen MB, Moller MH, Perner A. Early goal-directed nutrition versus standard of care in adult intensive care patients: the single-centre, randomised, outcome assessor-blinded EAT-ICU trial. Intensive Care Med. 2017 Nov;43(11):1637-1647. doi: 10.1007/s00134-017-4880-3. Epub 2017 Sep 22.
citation: Reignier J, Boisrame-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, Guerin 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, Thevenin 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.
citation: Piwowarczyk P, Kutnik P, Borys M, Rypulak E, Potrec-Studzinska B, Sysiak-Slawecka J, Czarnik T, Czuczwar M. Influence of Early versus Late supplemental ParenteraL Nutrition on long-term quality of life in ICU patients after gastrointestinal oncological surgery (hELPLiNe): study protocol for a randomized controlled trial. Trials. 2019 Dec 27;20(1):777. doi: 10.1186/s13063-019-3796-3.