Trace Element Repletion Following Severe Burn Injury

NCT ID: NCT03204669

Last Updated: 2017-07-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

139 participants

Study Classification

OBSERVATIONAL

Study Start Date

1999-06-01

Study Completion Date

2015-12-31

Brief Summary

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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

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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.

Conditions

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Critical Illness Nutritional Deficiency Trace Element Deficiency Burn Injury

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Trace elements replacement

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

14 Years

Maximum Eligible Age

86 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire Vaudois

OTHER

Sponsor Role lead

Responsible Party

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Mette M Berger

Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Lausanne University Hospital (Centre Hospitalier Universitaire Vaudois)

Lausanne, , Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type BACKGROUND
PMID: 16998143 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16376462 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17490965 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9701195 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26056754 (View on PubMed)

Other Identifiers

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X21

Identifier Type: -

Identifier Source: org_study_id

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