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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03204669
Other study ID # X21
Secondary ID
Status Completed
Phase N/A
First received June 26, 2017
Last updated June 28, 2017
Start date June 1, 1999
Est. completion date December 31, 2015

Study information

Verified date June 2017
Source Centre Hospitalier Universitaire Vaudois
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 139
Est. completion date December 31, 2015
Est. primary completion date December 31, 2015
Accepts healthy volunteers No
Gender All
Age group 14 Years to 86 Years
Eligibility 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 Design


Intervention

Other:
Trace elements replacement


Locations

Country Name City State
Switzerland Lausanne University Hospital (Centre Hospitalier Universitaire Vaudois) Lausanne

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire Vaudois

Country where clinical trial is conducted

Switzerland, 

References & Publications (5)

Berger MM, Baines M, Raffoul W, Benathan M, Chiolero RL, Reeves C, Revelly JP, Cayeux MC, Sénéchaud 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. — View 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. — View Citation

Berger MM. Antioxidant micronutrients in major trauma and burns: evidence and practice. Nutr Clin Pract. 2006 Oct;21(5):438-49. Review. — View 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. — View Citation

Shenkin A. The key role of micronutrients. Clin Nutr. 2006 Feb;25(1):1-13. Epub 2006 Jan 10. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary Length of mechanical ventilation Number of days on the ventilator by the time the patient is discharged from hospital. Up to 120 days
Secondary Length of stay Number of days spent in the ICU by the time the patient is discharged from hospital. Up to 250 days
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