NCT03204669

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
139

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 1999

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 1999

Completed
16.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2015

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 26, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 2, 2017

Completed
Last Updated

July 2, 2017

Status Verified

June 1, 2017

Enrollment Period

16.6 years

First QC Date

June 26, 2017

Last Update Submit

June 28, 2017

Conditions

Critical IllnessNutritional DeficiencyTrace Element DeficiencyBurn Injury

Keywords

CopperSeleniumZincContinuous renal replacement therapy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Number of infectious complications

    21 days

  • Length of mechanical ventilation

    Up to 120 days

  • Length of stay

    Up to 250 days

Interventions

Trace elements replacementOTHER

Eligibility Criteria

Age14 Years - 86 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

  • 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

You may not qualify if:

  • Comfort care
  • Admission \>24h after burn injury

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lausanne University Hospital (Centre Hospitalier Universitaire Vaudois)

Lausanne, 1011, Switzerland

Location

Related Publications (5)

  • 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.

    PMID: 16998143BACKGROUND

  • 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.

    PMID: 16376462BACKGROUND

  • 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.

    PMID: 17490965BACKGROUND

  • 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.

    PMID: 9701195BACKGROUND

  • 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.

    PMID: 26056754BACKGROUND

MeSH Terms

Conditions

Critical IllnessMalnutritionBurns

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsNutrition DisordersNutritional and Metabolic DiseasesWounds and Injuries

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof

Study Record Dates

First Submitted

June 26, 2017

First Posted

July 2, 2017

Study Start

June 1, 1999

Primary Completion

December 31, 2015

Study Completion

December 31, 2015

Last Updated

July 2, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)