Nutrition and Inflammation Among Patients With Lower Limb Amputation

NCT02540252 | Unknown DMC

• 1 other identifier: PSJ-2015
• Study Type: observational
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with non-traumatic lower limb amputation are characterized by; high age; majority being men; multimorbidity; and high mortality. The patients comorbidities are related to diabetes and cardiovascular disorders such as arteriosclerosis. Major surgery induces a surgical stress response that initiates a catabolic metabolism. Furthermore, the risk of systemic inflammatory response syndrome (SIRS) both before and after amputation is high (3) as the most prominent indication for amputation is gangrene, followed by non-healing or infected wounds. This leads to an impaired immune response and an increased insulin resistance that also includes a cascade of impaired appetite regulation, low dietary intake and reduced nutrient uptake form the intestine which increases inflammation, loss of muscle and risk of severe complications. Among healthy adults with a normal weight a slow speed of eating will result in a low nutritional intake due to faster satiety experience. Low appetite following major surgery is related to the regulation of hormone controlling the appetite. Especially older patients experience variations in appetite that affect their eating pattern such as eating speed and intake. It is therefore reasonable to assume that the speed of eating and the total nutritional intake among older patients, who are exposed to catabolic metabolism, are associated. The hypothesis is that major surgery induces a change in patients' current eating pattern that is measurable and can be identified as a surrogate measurement of the catabolic state that is related to inflammation. Eating Patterns are often described in clinical practice without engaging in nutritional assessment of the patient. Whether the speed of eating is an objective marker of the current nutritional status has not been established. This study investigates patients undergoing lower limb amputation and their nutritional status, eating pattern and inflammation and whether this is linked to the current degree of disease. The purpose is to describe the development in nutritional status before and after amputation and to investigate associations between patients eating pattern and nutritional status to inflammatory and metabolic biomarkers reflecting the degree of disease.

Conditions

Malnutrition; Inflammation

Keywords

Lower Limb Amputation; Nutrition; Eating; Inflammation; Nursing

Outcome Measures

Primary Outcomes (1)

• suPAR

  Soluble urokinase plasminogen activator receptor: Biomarker of low-grade inflammation. suPAR are measured prior to surgery and on the 1, 3, 5 and 10 postoperative day and will be compared to patients daily intake of energy (kilojoule) and protein (gram)

  From admission to ten days after surgery

Secondary Outcomes (10)

• Inflammatory biomarkers such as IL6, IL10,IL18, TNF-a, MCP-1, sCD14, C reactive protein, expression of inflammatory genes from immucell

  From admission to ten days after surgery

• Metabolic biomarkers such as Insulin, Glucose, Adiponectin, Leptin, Ghrelin

  From admission to ten days after surgery

• Postoperative LOS from surgery to medical stability (planned disharge)

  From surgery to discharge

• Revisions or re-amputation

  From surgery to discharge

• Severity of Infections

  From surgery to discharge

Interventions

Nutritional status among patients with lower limb amputation OTHER

Patients nutritional status, inflammatory and metabolic pathway are observed during their hospitalization.

Also known as: Inflammation and metabolic pathway

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients are included from a cohort of patients who are admitted to the Department of Ortopedic Surgery.

You may qualify if:

• Having a medical indication for amputation
• Admitted with a non healing wound on lower limb
• Revision following previous amputation
• Able to speak and understand Danish - able to give an informed consent

You may not qualify if:

• Traumatic or pathologic indication for amputation
• Any or current use of narcotics
• Major surgery within the last four weeks
• If not amputated two weeks after admission

Sponsors & Collaborators

• Hvidovre University Hospital: lead

Study Sites (1)

University Hospital of Copenhagen, Hvidovre

Hvidovre, Copenhagen, 2650, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

Serum and plasma samples; peripheral blood mononuclear cells (PBMCs); and muscle biopsies

MeSH Terms

Conditions

Malnutrition; Inflammation

Interventions

Metabolic Networks and Pathways

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Metabolism

Study Officials

• Ove Andersen, PHD,MD

  Clinical Research Centre, University Hospital of Copenhagen, Hvidovre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Director

Study Record Dates

• First Submitted: September 1, 2015
• First Posted: September 3, 2015
• Study Start: August 19, 2015
• Primary Completion: November 13, 2016
• Study Completion: April 1, 2017
• Last Updated: January 27, 2017

Record last verified: 2017-01

Locations

DK (1)