Clinical trial NCT03204669: Trace Element Repletion Following Severe Burn Injury
Official title: Trace Element Repletion Following Severe Burn Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critical Illness
Nutritional Deficiency
Trace Element Deficiency
Burn Injury
Keywords: Copper
Selenium
Zinc
Continuous renal replacement therapy
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
First posted: 2017-07-02
Enrollment: 139
Sex: ALL
Minimum age (years): 14
Maximum age (years): 86
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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).

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Trace elements plasma concentration
timeFrame: 21 days
Secondary outcomes:
measure: Number of infectious complications
timeFrame: 21 days
measure: Length of mechanical ventilation
timeFrame: Up to 120 days
measure: Length of stay
timeFrame: Up to 250 days
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Lausanne University Hospital (Centre Hospitalier Universitaire Vaudois)
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.