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BurnsNCT00326729

Fluid Shifts During Resuscitation: Impacts on Macrocirculation and Microcirculation

An observational study of Burns, run by Montreal Burn Centre at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Burns
How many people
40 participants
Where
1 siteCanada
Study dates
May 2006to not given
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Canada1 site, 1 recruiting
  • Centre Hospitalier de l'Universite de Montreal

    Montreal, Quebec, H2W1T8

    Patrice Deroy, 514-890-8000 ext. 15066, patrice.deroy.chum@ssss.gouv.qc.ca

    David Bracco, MD

    Recruiting

Other trials in Canada

About this study

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. investigators do have a time 'zero' for burn patients; they know exactly when the insult occurred;
  2. apart from fluid resuscitation, the management of burn patients is uniform in the investigators' unit and is done according to various protocols;
  3. the burn population is more uniform than the septic population making confounders and background noises less likely; and
  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.
Read more

Studies that have addressed the question of fluid resuscitation in burn patients are quite numerous. However, they are either under-powered, dealing with various interventions or outcomes and sometimes of poor methodological quality.

Moving the investigators' focus from macrohemodynamic to microhemodynamic monitoring is now essential and due to recent technological advances, severe impairments in microcirculatory perfusion are now being recognized in various pathological states. What is now clear from various studies is the fact that even with restoring 'normal' macrocirculatory parameters, severe microcirculatory alterations can be seen.

This study is an integral part of a program aimed to explore different questions regarding fluid resuscitation in burn patients. The aim is to characterize changes in fluid shift, fluid accumulation, and vascular volumes after burn injury and also to study the effects of an artificial colloid on different macrocirculatory and microcirculatory parameters. The primary end points are:

  1. fluid accumulation during the initial phase; and
  2. short term effects of colloids on macrocirculatory and microcirculatory parameters.

This study will collect data on macro- and microcirculation derived from current monitoring systems. Data (see below) will be collected at defined time points and before and after the first two fluid challenges. If the fluid challenge occurs in a one hour time frame of a defined time point, only one assessment will be done.

  1. 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.
  2. 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.

In this study, the two first fluid challenges will be allocated according to a random list. One bolus will be Pentaspan (500 ml) and the other will be a crystalloid solution (Ringer's lactate 1000 ml). These two alternatives represent a true equipoise as they are equally acceptable because choosing one of them depends on the preference of the attending physician. Fluid challenges will be allocated using a randomised short block cross-over sequence.

The following parameters will be measured at a fixed time and before and after the fluid challenges using different techniques.

Parameters:

Intrathoracic blood volume, extravascular lung water, total blood volume; extracellular edema; intraventricular preload, ventricular volumes, diastolic function; cardiac output; mixed venous saturation; oncotic pressure; microcirculatory assessment: number and diameter of capillaries, proportion of perfusion, and flow velocities.

This is an observational, one-group study aimed at describing macrocirculation and microcirculation parameters in a burn patient population. The investigators arbitrarily plan to enroll 40 patients.

Conditions
Burns
Keywords
burns, thermal injury, hemodynamics, microcirculation
Medical subject headings
Burns

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 May 2006 (estimated)
  2. Study startMay 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Defined population
Time perspective
Other
Enrolment
40 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00326729
Sponsor's protocol ID
HD06-004
Status last verified
May 2006
First submitted
15 May 2006
Last updated
16 Jun 2006
Results posted
No

Questions about this trial

What is this clinical trial studying?

An observational study of Burns, run by Montreal Burn Centre at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 Jun 2006. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Patrice Deroy (514-890-8000 ext. 15066, patrice.deroy.chum@ssss.gouv.qc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2006.

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Clinical Trial NCT00326729 | AzTrials