Burns Clinical Trial
— MIPAOfficial title:
A Single-centre Prospective Observational Study of MIcrocirculatory Perfusion Alterations in Severe Burn Injury
Verified date | October 2020 |
Source | Maasstad Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 21 |
Est. completion date | September 15, 2020 |
Est. primary completion date | September 15, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. ICU admission with a severe burn injuries of =15% TBSA 2. = 18 years of age 3. Receiving standard resuscitation protocol for severe burn injury 4. Post burn time up to a maximum of 24 hours Exclusion Criteria: 1. Informed consent not obtained 2. (suspected) generalised infection 3. 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 4. Patients unlikely to survive >24 hours 5. Decision not to initiate treatment |
Country | Name | City | State |
---|---|---|---|
Netherlands | Maasstad Hospital | Rotterdam | Zuid Nederland |
Lead Sponsor | Collaborator |
---|---|
Maasstad Hospital |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Measurement of microcirculatory perfusion alterations in severe burns patients during standard fluid resuscitation. | The main objective of our study is to measure standard microcirculatory perfusion parameters during standard resuscitation at different time points after a severe burn injury. These perfusion parameters are total vessel density (TVD), proportion of perfused vessels (PPV), functional capillary density (FCD) and focus depth. | 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 | |
Secondary | Microcirculatory perfusion alterations after administration of albumin. | Secondary objectives are to measure changes in standard microcirculatory parameters before and after administration of albumin. Albumin will be administered 12 hours after admission of the patient. | Changes in microcirculatory perfusion parameters will be measured directly after administration of albumin. This will be 12 hours after starting fluid resuscitation. |
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