Trace Element Repletion Following Severe Burn Injury

Critical Illness Clinical Trial

Official title:

Trace Element Repletion Following Severe Burn Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03204669
• Other study ID #: X21
• 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
• 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

Related Conditions & MeSH terms

• Burn Injury
• Burns
• Critical Illness
• Malnutrition
• Nutritional Deficiency
• Trace Element Deficiency
• Wounds and Injuries

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