Trace Element Repletion Following Severe Burn Injury

Major burn patients are characterized by large exudative losses of Cu, Se and Zn. Trace element (TE) repletion has been shown to improve clinical outcome. The study aimed to check if our repletion protocols were achieving normalization of TE plasma concentrations of major burn patients and if the necessity for continuous renal replacement therapy (CRRT) might increase the needs.

Study Overview

• Status: Completed
• Conditions: Critical Illness; Burn Injury; Nutritional Deficiency; Trace Element Deficiency
• Intervention / Treatment: Other: Trace elements replacement

Detailed Description

Retrospective analysis of prospectively collected data in burn patients requiring intensive care (ICU) between 1999 and 2015. The cohort was divided into 4 groups according to the protocol changes. Period 1 (P1): 1999-2000, P2: 2001-2005, P3: 2006-2010, P4: 2011-2015. Changes consisted mainly in increasing TE repletion doses and duration. Demographic data, daily TE intakes and weekly plasma concentrations were retrieved for the first 21 ICU-days.

• Study Type: Observational
• Enrollment (Actual): 139

Contacts and Locations

Study Locations

• Switzerland
  • Lausanne, Switzerland, 1011
    • Lausanne University Hospital (Centre Hospitalier Universitaire Vaudois)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 86 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Consecutive burns admissions to the ICU, between June 1st, 1999 and December 31st, 2015 in a Swiss quaternary care hospital (Lausanne University Hospital, Centre Hospitalier Universitaire Vaudois).

Description

Inclusion Criteria:

• Burn injury involving ≥20% body surface (TBSA) (i.e. the threshold for intravenous TE repletion prescription)
• At least one TE plasma concentration during the ICU stay

Exclusion Criteria:

• Comfort care
• Admission >24h after burn injury

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Trace elements plasma concentration	Copper, Selenium and Zinc plasma concentrations, measured by inductively coupled plasma mass spectrometry (ICP-MS). The recommendation was to check them on a weekly basis.	21 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of infectious complications	Infectious complications retrieved from the discharge reports, based on microbiological findings and antibiotherapy introduction or rotation. Multiple positive cultures were considered only once when they were related to a unique infectious episode. Concomitant sites of infection, including primary bloodstream infections, were considered as separate episodes of infections. Episodes of infections due to several microorganisms were considered only once. Infections were defined according to the criteria of the Center for Disease Control (CDC), American Burn Association (ABA) and International sepsis forum.	21 days
Length of mechanical ventilation	Number of days on the ventilator by the time the patient is discharged from hospital.	Up to 120 days
Length of stay	Number of days spent in the ICU by the time the patient is discharged from hospital.	Up to 250 days

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Vaudois

Publications and helpful links

General Publications

• Berger MM. Antioxidant micronutrients in major trauma and burns: evidence and practice. Nutr Clin Pract. 2006 Oct;21(5):438-49. doi: 10.1177/0115426506021005438.
• Shenkin A. The key role of micronutrients. Clin Nutr. 2006 Feb;25(1):1-13. doi: 10.1016/j.clnu.2005.11.006. Epub 2006 Jan 10.
• Berger MM, Baines M, Raffoul W, Benathan M, Chiolero RL, Reeves C, Revelly JP, Cayeux MC, Senechaud I, Shenkin A. Trace element supplementation after major burns modulates antioxidant status and clinical course by way of increased tissue trace element concentrations. Am J Clin Nutr. 2007 May;85(5):1293-300. doi: 10.1093/ajcn/85.5.1293.
• Berger MM, Spertini F, Shenkin A, Wardle C, Wiesner L, Schindler C, Chiolero RL. Trace element supplementation modulates pulmonary infection rates after major burns: a double-blind, placebo-controlled trial. Am J Clin Nutr. 1998 Aug;68(2):365-71. doi: 10.1093/ajcn/68.2.365.
• Kurmis R, Greenwood J, Aromataris E. Trace Element Supplementation Following Severe Burn Injury: A Systematic Review and Meta-Analysis. J Burn Care Res. 2016 May-Jun;37(3):143-59. doi: 10.1097/BCR.0000000000000259.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 1999
• Primary Completion (Actual): December 31, 2015
• Study Completion (Actual): December 31, 2015

Study Registration Dates

• First Submitted: June 26, 2017
• First Submitted That Met QC Criteria: June 28, 2017
• First Posted (Actual): July 2, 2017

Study Record Updates

• Last Update Posted (Actual): July 2, 2017
• Last Update Submitted That Met QC Criteria: June 28, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: Zinc; Selenium; Copper; Continuous renal replacement therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Nutrition Disorders; Burns; Wounds and Injuries; Critical Illness; Malnutrition; Physiological Effects of Drugs; Micronutrients; Trace Elements
• Other Study ID Numbers: X21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No