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

NCT ID: NCT03699371

Last Updated: 2018-10-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-01
• Study Completion Date: 2021-05-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Early Supplemental Parenteral Nutrition

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Uniwersytecki Szpital Kliniczny w Opolu

OTHER

Sponsor Role: collaborator

Medical University of Lublin

OTHER

Sponsor Role: lead

Responsible Party

Paweł Piwowarczyk

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paweł Piwowarczyk, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Medical University in Lublin

Locations

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

Lublin, Lublin Voivodeship, Poland

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

Opole, Silesian Voivodeship, Poland

Countries

Poland

Central Contacts

Paweł Piwowarczyk, MD PhD

Role: CONTACT

piwowarczyk.pawel@gmail.com

815372713 ext. +48

Facility Contacts

Paweł Piwowarczyk, MD PhD

Role: primary

piwowarczyk.pawel@gmail.com

511285352 ext. +48

References

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Reference Type: DERIVED

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Other Identifiers

KE-0254/152/2018

Identifier Type: -

Identifier Source: org_study_id