hELPLiNe: Influence of Early vs Late SPN on Long-term Quality of Life in ICU Patients After Gastrointestinal Oncological Surgery
Study Details
Study Description
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 |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| 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. |
Outcome Measures
Primary Outcome Measures
- Long-term quality of life at 3 months [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
- Long-term quality of life at 6 months [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
- Enteral route intolerance [At day 3 since admission to ICU]
Inability to administer up to 60% of protein needs on 3rd day via enteral route
- Thickness of diaphragm [1st, 3rd, 5th day of ICU stay]
Change from baseline in ultrasound measured thickness of diaphragm
- Protein delivery [For 7 days since admission to ICU]
Protein delivery defined as daily input of proteins via SPN
- Energy Intake [For 7 days since admission to ICU]
Energy delivery defined as daily input of calories via SPN
- Insulin dose [For 7 days since admission to ICU]
Insulin dose defined as summary daily input of insulin
- Blood glucose profile [For 7 days since admission to ICU]
Blood glucose profile defined as mean daily glucose level
- Organic phosphorus level [For 7 days since admission to ICU]
Organic phosphorus level defined as result in blood test performed daily
- Sequential Organ Failure Assessment score ( SOFA score) [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.
- Mechanical Ventilation [For 28 days since admission to ICU or till discharge]
Numbers of days of mechanical ventilation
- Length of stay in the ICU [For 28 days since admission to ICU or till discharge]
Numbers of days of patient stay in ICU
- ICU mortality [For 28 days since admission to ICU or till discharge]
- Hospital mortality [For 28 days since admission to ICU or till discharge]
- Length of stay in hospital [For 28 days since admission to ICU or till discharge]
Numbers of days of patient stay in hospital
- Health-care associated infection [For 28 days since admission to ICU or till discharge]
New onset of health-care associated infection
- Antibiotic-free days [For 28 days since admission to ICU or till discharge]
Number of days patient was not given the antibiotics
Other Outcome Measures
- PCS SF-36 change [From enrollment till 6 months assessment]
Change from baseline in PCS SF-36
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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
Exclusion Criteria:
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
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 2nd Department of Anesthesiology and Critical Care, Medical University of Lublin | Lublin | Lubelskie | Poland | 20-059 |
| 2 | 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
- Principal Investigator: Paweł Piwowarczyk, MD PhD, Medical University in Lublin
Study Documents (Full-Text)
None provided.More Information
Publications
- Allingstrup MJ, Kondrup J, Wiis J, Claudius C, Pedersen UG, Hein-Rasmussen R, Bjerregaard MR, Steensen M, Jensen TH, Lange T, Madsen MB, Møller 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.
- Arends J, Bachmann P, Baracos V, Barthelemy N, Bertz H, Bozzetti F, Fearon K, Hütterer E, Isenring E, Kaasa S, Krznaric Z, Laird B, Larsson M, Laviano A, Mühlebach 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.
- 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.
- 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. Erratum in: JAMA. 2014 Feb 12;311(6):625. Padhke, Rahul [corrected to Phadke, Rahul].
- 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.
- Sundström Rehal M, Liebau F, Tjäder I, Norberg Å, 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.
- KE-0254/152/2018