A Study of MIcrocirculatory Perfusion Alterations in Severe Burn Injury (NCT04500197) | Clinical Trial Compass
CompletedNot Applicable
A Study of MIcrocirculatory Perfusion Alterations in Severe Burn Injury
Netherlands21 participantsStarted 2018-11-12
Plain-language summary
The main objective of our study is to focus on the efficiency of standard fluid resuscitation in promoting tissue perfusion in severe burns patients (\>15% TBSA). The incidence of microcirculatory perfusion alterations, according to a predefined arbitrary cut off value, in patients with severe burns injury (\>15%TBSA) will be assessed during standard resuscitation in the first 24 hours.
Secondary objectives are to assess differences in microcirculatory perfusion alterations between early (\<12 hours post burn injury) and late standard resuscitation (\>12 hours post burn injury) with addition of albumin to the regime.
And to measure several biomarkers of glycocalyx shedding, oxidative stress and inflammation.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. ICU admission with a severe burn injuries of ≥15% TBSA
. ≥ 18 years of age
. Receiving standard resuscitation protocol for severe burn injury
. Post burn time up to a maximum of 24 hours
Exclusion criteria
. Informed consent not obtained
. (suspected) generalised infection
. Other traumatic injury, which is supposed to generate a systemic inflammatory response eg severe fractures, or other types of shock as a result of massive bleeding
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Measurement of microcirculatory perfusion alterations in severe burns patients during standard fluid resuscitation.
Timeframe: Changes in perfusion parameters will be measured on admission (time zero, T=0), four hours after admission (T=4), eight hours after admission (T=8), twelve hours after admission (T=12) and twenty-four hours after admission (T=24