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Nutrition Aspect of CancerhELPLiNeNCT03699371

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

A study testing Early Supplemental Parenteral Nutrition in people with Nutrition Aspect of Cancer, run by Medical University of Lublin at 2 sites in Poland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Nutrition Aspect of Cancer
What is being tested?
Early Supplemental Parenteral Nutrition
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
220 participants
Where
2 sitesPoland
Study dates
1 Nov 2018to 1 May 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 26Show fewer
  • 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
  • Laboratory Exclusions:
  • Hypertriglyceridemia characterised by serum triglyceride levels >4 mmol/L [>350 mg/dL])
  • Treatment-refractory, clinically significant major abnormality in the serum concentration of any electrolyte (sodium, potassium, magnesium, total calcium, chloride, inorganic phosphate)
  • Concomitant Therapy Exclusions:
  • Chronic maintenance therapy with systemic glucocorticoid steroids (Hydrocortisone >0.3 mg/kg/d)
  • Concomitant administration of chemotherapy
  • Administration of growth hormone and teduglutide within the previous 4 weeks
  • Other Exclusions:
  • Chronic liver failure ( Child -Pugh scale B or C) e.g. secondary to drug or alcohol abuse
  • Participation in another interventional clinical trial within the previous 4 weeks
  • Previous inclusion in the present study

Trial locations and contacts

2 sites in 1 country.

Paweł Piwowarczyk, MD PhD contact

815372713 ext. +48

piwowarczyk.pawel@gmail.com

Poland2 sites

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

    Lublin, Lublin Voivodeship, 20-059

    Paweł Piwowarczyk, MD PhD, 511285352 ext. +48, piwowarczyk.pawel@gmail.com

    Mirosław Czuczwar, MD PhD

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

    Opole, Silesian Voivodeship, 45-401

Other trials in Poland

About this study

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

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.

Being tested
Early Supplemental Parenteral Nutrition
Keywords
early parenteral nutrition, supplemental nutrition, quality of life, oncological surgery, critical care
Medical subject headings
Hyperphagia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Early Supplemental Parenteral NutritionProcedure or surgery

    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.

Study groups in NCT03699371
Study groupRoleWhat they receive
Early Supplemental Parenteral NutritionExperimentalIntervention 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.
Receives: Procedure: Early Supplemental Parenteral Nutrition
Late Supplemental Parenteral NutritionNo interventionControl 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Long-term quality of life at 3 months

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

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

  2. Long-term quality of life at 6 months

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

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

Secondary outcomes (15)

  1. Enteral route intolerance

    Inability to administer up to 60% of protein needs on 3rd day via enteral route

    Measured: At day 3 since admission to ICU

  2. Thickness of diaphragm

    Change from baseline in ultrasound measured thickness of diaphragm

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

  3. Protein delivery

    Protein delivery defined as daily input of proteins via SPN

    Measured: For 7 days since admission to ICU

  4. Energy Intake

    Energy delivery defined as daily input of calories via SPN

    Measured: For 7 days since admission to ICU

  5. Insulin dose

    Insulin dose defined as summary daily input of insulin

    Measured: For 7 days since admission to ICU

  6. Blood glucose profile

    Blood glucose profile defined as mean daily glucose level

    Measured: For 7 days since admission to ICU

  7. Organic phosphorus level

    Organic phosphorus level defined as result in blood test performed daily

    Measured: For 7 days since admission to ICU

  8. Sequential Organ Failure Assessment score ( SOFA score)

    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.

    Measured: For 28 days since admission to ICU or till discharge

  9. Mechanical Ventilation

    Numbers of days of mechanical ventilation

    Measured: For 28 days since admission to ICU or till discharge

  10. Length of stay in the ICU

    Numbers of days of patient stay in ICU

    Measured: For 28 days since admission to ICU or till discharge

  11. ICU mortality

    Measured: For 28 days since admission to ICU or till discharge

  12. Hospital mortality

    Measured: For 28 days since admission to ICU or till discharge

  13. Length of stay in hospital

    Numbers of days of patient stay in hospital

    Measured: For 28 days since admission to ICU or till discharge

  14. Health-care associated infection

    New onset of health-care associated infection

    Measured: For 28 days since admission to ICU or till discharge

  15. Antibiotic-free days

    Number of days patient was not given the antibiotics

    Measured: For 28 days since admission to ICU or till discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Oct 2018
  2. Study start1 Nov 2018 (estimated)
  3. Primary completion1 Nov 2020 (estimated)
  4. Study completion1 May 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
prospective, randomised, multi-centre assessor-blinded study
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
220 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03699371
Sponsor's protocol ID
KE-0254/152/2018
Acronym
hELPLiNe
Status last verified
Oct 2018
First submitted
4 Oct 2018
Last updated
12 Oct 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 25900319

  • 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.

    PubMed 24108501

  • 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.

    PubMed 29212550

  • 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.

    PubMed 27637832

  • 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.

    PubMed 28936712

  • 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.

    PubMed 29128300

  • 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.

    PubMed 31881984

Questions about this trial

What is this clinical trial studying?

A study testing Early Supplemental Parenteral Nutrition in people with Nutrition Aspect of Cancer, run by Medical University of Lublin at 2 sites in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Paweł Piwowarczyk, MD PhD (815372713 ext. +48, piwowarczyk.pawel@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Long-term quality of life at 3 months (time frame: Physical component of 36 -SF questionnaire at 3 months after admission to ICU). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03699371, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2018.

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