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

NCT03699371 | Unknown

• 1 other identifier: KE-0254/152/2018
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 2

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.

Conditions

Nutrition Aspect of Cancer

Keywords

early parenteral nutrition; supplemental nutrition; quality of life; oncological surgery; critical care

Outcome Measures

Primary Outcomes (2)

• Long-term quality of life at 3 months

  Long-term quality of life measured in physical component of 36 -SF questionnaire

  Physical component of 36 -SF questionnaire at 3 months after admission to ICU

• Long-term quality of life at 6 months

  Long-term quality of life measured in physical component of 36 -SF questionnaire

  Physical component of 36 -SF questionnaire at 6 months after admission to ICU

Secondary Outcomes (15)

• Enteral route intolerance

  At day 3 since admission to ICU

• Thickness of diaphragm

  1st, 3rd, 5th day of ICU stay

• Protein delivery

  For 7 days since admission to ICU

• Energy Intake

  For 7 days since admission to ICU

• Insulin dose

  For 7 days since admission to ICU

Other Outcomes (1)

• PCS SF-36 change

  From enrollment till 6 months assessment

Study Arms (2)

Early Supplemental Parenteral Nutrition

EXPERIMENTAL

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

Late Supplemental Parenteral Nutrition

NO INTERVENTION

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.

Interventions

Early Supplemental Parenteral Nutrition PROCEDURE

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.

Early Supplemental Parenteral Nutrition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Contraindication against SPN or inability to receive SPN via central venous access
• Received PN within 7 days before randomisation
• 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
• Inability to initiate EN prior to randomization
• Body mass index (BMI) \<17 kg/m2 or \>35 kg/m2
• Any severe, persistent blood coagulation disorder with uncontrolled bleeding
• Any congenital errors of amino acid metabolism
• Known hypersensitivity to fish, egg, soybean proteins, peanut proteins, or to any of the active substances or excipients contained in SPN.
• Known hypersensitivity to milk protein or to any other substance contained in SPN
• 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
• Hemophagocytic syndrome
• Known history of human immunodeficiency virus (HIV), hepatitis B and/or C
• Pregnancy or lactation
• Patient unlikely to survive to 6 months due to underlying illness
• Receiving end-of-life-care

Sponsors & Collaborators

• Medical University of Lublin: lead
• Uniwersytecki Szpital Kliniczny w Opolu: collaborator

Study Sites (2)

2nd Department of Anesthesiology and Critical Care, Medical University of Lublin

Lublin, Lublin Voivodeship, 20-059, Poland

Location

Department of Anesthesiology and Intensive Care, Uniwersytecki Szpital Kliniczny w Opolu

Opole, Silesian Voivodeship, 45-401, Poland

Location

Related Publications (7)

• 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.

  PMID: 25900319 BACKGROUND

• 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.

  PMID: 24108501 BACKGROUND

• 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.

  PMID: 29212550 BACKGROUND

• 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.

  PMID: 27637832 BACKGROUND

• 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.

  PMID: 28936712 BACKGROUND

• 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.

  PMID: 29128300 BACKGROUND

• 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.

  PMID: 31881984 DERIVED

MeSH Terms

Conditions

Hyperphagia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Paweł Piwowarczyk, MD PhD

  Medical University in Lublin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paweł Piwowarczyk, MD PhD

CONTACT

815372713; piwowarczyk.pawel@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: prospective, randomised, multi-centre assessor-blinded study

Study Record Dates

• First Submitted: October 4, 2018
• First Posted: October 9, 2018
• Study Start: November 1, 2018
• Primary Completion: November 1, 2020
• Study Completion: May 1, 2021
• Last Updated: October 12, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

PL (2)