NCT00326729

Brief Summary

Fluid resuscitation in burn patients is associated with major macrocirculatory and microcirculatory disturbances that have been poorly described. When done according to expert opinions, it is now rare to encounter the death of a patient due to an inadequate fluid resuscitation. Fluid resuscitation in burn patients is more opinion-based than evidence-based. Although burn admission to an intensive care facility is relatively rare, the burn patient is well suited to answer questions in the fluid resuscitation field because, as opposed to other critically ill patients:

  1. 1.investigators do have a time 'zero' for burn patients; they know exactly when the insult occurred;
  2. 2.apart from fluid resuscitation, the management of burn patients is uniform in the investigators' unit and is done according to various protocols;
  3. 3.the burn population is more uniform than the septic population making confounders and background noises less likely; and
  4. 4.as basic as it might sound, studying fluid resuscitation implies accomplishing a significant one; burn patients are the category of critically ill patients receiving the most important fluid resuscitation.
  5. 5.fluid accumulation during the initial phase; and
  6. 6.short term effects of colloids on macrocirculatory and microcirculatory parameters.
  7. 7.At defined time points: a set of data (see below) will be collected by the research team at baseline, 6, 12, 18, 24, 36, 48 and 72 hours after burn injury. Baseline values will be the ones obtained immediately after consent.
  8. 8.Fluid challenges: Burn patients often require additional fluid bolus to maintain hemodynamic stability because of the following reasons: hypotension; decreased urine output (less than 0.5 ml/kg/hour); uncorrected metabolic acidosis; rhabdomyolysis; increasing hematocrit; or any other clinical reason according to the attending physician.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

May 15, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 17, 2006

Completed
Last Updated

June 16, 2006

Status Verified

May 1, 2006

First QC Date

May 15, 2006

Last Update Submit

June 15, 2006

Conditions

Keywords

burnsthermal injuryhemodynamicsmicrocirculation

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Major thermal, electrical, or chemical burns
  • Admission to the burn unit within 6 hours after burn
  • Burned surface area over 20% or equivalent
  • Signed consent by the patient or relative
  • Commitment to full maximal support

You may not qualify if:

  • Patient under 18 years old
  • Patient over 80 years old
  • Pregnancy
  • Chronic renal failure requiring dialysis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, H2W1T8, Canada

RECRUITING

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • David Bracco, MD

    Centre Hospitalier de l'Universite de Montreal

    PRINCIPAL INVESTIGATOR
  • Marc-Jacques Dubois, MD

    Centre Hospitalier de l'Universite de Montreal

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
OTHER
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 15, 2006

First Posted

May 17, 2006

Study Start

May 1, 2006

Last Updated

June 16, 2006

Record last verified: 2006-05

Locations