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Completed

NCT Number: NCT03204669

Trace Element Repletion Following Severe Burn Injury

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.

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Key information

Conditions

Critical Illness Burn Injury Burns Disease Attributes Malnutrition Nutrition Disorders Nutritional Deficiency Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Trace Element Deficiency Wounds and Injuries

Age range

14 year–86 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Lausanne University Hospital (Centre Hospitalier Universitaire Vaudois)

Lausanne, 1011, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Trace elements replacement

Other

Primary outcomes

  1. Trace elements plasma concentration

    Time frame: 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 outcomes

  1. Number of infectious complications

    Time frame: 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.

  2. Length of mechanical ventilation

    Time frame: Up to 120 days

    Number of days on the ventilator by the time the patient is discharged from hospital.

  3. Length of stay

    Time frame: Up to 250 days

    Number of days spent in the ICU by the time the patient is discharged from hospital.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Vaudois

Other

Registry information

Important dates

Study start
1999
Primary completion
2015
Study completion
2015
First posted
Jul 2, 2017
Registry last updated
Jul 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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