Trace Element Repletion Following Severe Burn Injury

Completed

• Conditions: Critical Illness; Nutritional Deficiency; Burn Injury; Trace Element Deficiency

• Registration Number: NCT03204669
• Lead Sponsor: 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.

Study Timeline

• Study Start: 1999-06-01
• Primary Completion: 2015-12-31
• Study Completion: 2015-12-31
• Status Verified: 2017-06
• Study First Submitted: 2017-06-26
• Study First Submitted QC: 2017-06-28
• Last Update Submitted: 2017-06-28
• Study First Posted: 2017-07-02
• Last Update Posted: 2017-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 139

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Trace elements plasma concentration	21 days	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.

Secondary Outcome Measures

Name	Time	Method
Number of infectious complications	21 days	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.
Length of mechanical ventilation	Up to 120 days	Number of days on the ventilator by the time the patient is discharged from hospital.
Length of stay	Up to 250 days	Number of days spent in the ICU by the time the patient is discharged from hospital.

Trial Locations

Locations (1)

Lausanne University Hospital (Centre Hospitalier Universitaire Vaudois); 🇨🇭 Lausanne, Switzerland