MicrocirculationMIPANCT04500197
A Study of MIcrocirculatory Perfusion Alterations in Severe Burn Injury
An observational study of Microcirculation and Burns, run by Maasstad Hospital at 1 site in Netherlands.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Microcirculation, Burns, Resuscitation
- How many people
- 21 participants
- Where
- 1 siteNetherlands
- Study dates
- 12 Nov 2018to 15 Sep 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 30 patients admitted to the ICU with a severe burn ≥15% TBSA will be given standard resuscitation care and will be included
Who may be able to join
- 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
Who cannot join
- 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
- Patients unlikely to survive >24 hours
- Decision not to initiate treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-centre Prospective Observational Study of MIcrocirculatory Perfusion Alterations in Severe Burn Injury
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.
Read the detailed description
Rationale: There are valid concerns that resuscitation in burns shock is inadequate. A tendency to over resuscitate patients seem to exist. Current guidelines were developed 35 years ago and clinical burn resuscitation has not advanced significantly, despite ongoing research. The main goal of resuscitation is achieving organ perfusion and tissue oxygenation. Inadequate fluid resuscitation of severe acute burns may result in hypovolemic shock and death. Excessive fluid resuscitation may result in fluid overload, lung edema, intra-abdominal hypertension, abdominal compartment syndrome and burn depth conversion with increased requirement for escharotomies, fasciotomies and skin grafting. Monitoring of adequacy of resuscitation in burns patients has always been guided by systemic hemodynamic variables (macro circulation) like blood pressure, heart rate, stroke volume and urinary output, being urine output the major indicator of successful resuscitation. Whether these end points are successful in achieving adequate perfusion and oxygen transport to the tissues is unknown and relies on the assumption that there is a hemodynamic coherence between the macro and microcirculation whereby improving the macro circulation causes a parallel improvement in the microcirculation Objective: The main objective of our study is to focus on the efficacy of standard fluid resuscitation in promoting tissue perfusion.
Study design: Single-center, prospective, observational clinical study in the Maasstad Hospital.
Study population: All adult patients who are admitted to the Intensive Care Unit with severe burns over 15%TBSA and resuscitated with the standard resuscitation protocol will be included.
Main study parameters/endpoints: Measurement of sublingual microcirculation with vessel density and flow parameters. Also skin perfusion maps (Laser Speckle Imaging) will be recorded. Blood and urine samples will also be used for measuring glycocalyx shedding products.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
Microcirculation assessment and laser speckle imaging are non-invasive procedures, and there are negligible risks. Blood tests will be used for measuring glycocalyx shedding products, this is an invasive procedure which may increase the risk of contamination, patient discomfort and in some extreme cases blood sample collection may be a burden on patient haemoglobin levels which is prone to decrease in critical patients. Assessment is essential for determining whether action is required to change our existing resuscitation regime for critically ill burned patients. If the results show that the current resuscitation regime is suboptimal, then motivation for changing the existing practice can lead to improved clinical care and a reduction in over- or under resuscitation in the ICU environment with its potential harmful effects.
The risks associated with participation can be considered negligible and the burden can be considered minimal in this observational study. The patients taking part in this study will have no direct benefit.
- Conditions
- Microcirculation, Burns, Resuscitation
- Keywords
- microcirculation, burns, resuscitation
- Medical subject headings
- Burns
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 outcomes (1)
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.
Measured: Changes in microcirculatory perfusion parameters will be measured directly after administration of albumin. This will be 12 hours after starting fluid resuscitation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2020
- Study start12 Nov 2018
- Primary completion15 Sep 2020
- Study completion15 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MicrocirculationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Case only
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maasstad Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Can Ince, Prof, Study director, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04500197
- Sponsor's protocol ID
- L2015126
- Acronym
- MIPA
- Status last verified
- Oct 2020
- First submitted
- 20 Sep 2019
- Last updated
- 14 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-centre Prospective Observational Study of MIcrocirculatory Perfusion Alterations in Severe Burn Injury
- ClinicalTrials.gov ID
- NCT04500197
- Acronym / sponsor ID
- MIPA / L2015126
- Conditions
- Microcirculation, Burns, Resuscitation
- Keywords
- microcirculation, burns, resuscitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Maasstad HospitalUniversity, hospital or other
- Study start
- 12 Nov 2018 (actual)
- Primary completion
- 15 Sep 2020 (actual)
- Study completion
- 15 Sep 2020 (actual)
- First posted
- 5 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Rationale: There are valid concerns that resuscitation in burns shock is inadequate. A tendency to over resuscitate patients seem to exist. Current guidelines were developed 35 years ago and clinical burn resuscitation has not advanced significantly, despite ongoing research. The main goal of resuscitation is achieving organ perfusion and tissue oxygenation. Inadequate fluid resuscitation of severe acute burns may result in hypovolemic shock and death. Excessive fluid resuscitation may result in fluid overload, lung edema, intra-abdominal hypertension, abdominal compartment syndrome and burn depth conversion with increased requirement for escharotomies, fasciotomies and skin grafting. Monitoring of adequacy of resuscitation in burns patients has always been guided by systemic hemodynamic variables (macro circulation) like blood pressure, heart rate, stroke volume and urinary output, being urine output the major indicator of successful resuscitation. Whether these end points are successful in achieving adequate perfusion and oxygen transport to the tissues is unknown and relies on the assumption that there is a hemodynamic coherence between the macro and microcirculation whereby improving the macro circulation causes a parallel improvement in the microcirculation Objective: The main objective of our study is to focus on the efficacy of standard fluid resuscitation in promoting tissue perfusion.
Study design: Single-center, prospective, observational clinical study in the Maasstad Hospital.
Study population: All adult patients who are admitted to the Intensive Care Unit with severe burns over 15%TBSA and resuscitated with the standard resuscitation protocol will be included.
Main study parameters/endpoints: Measurement of sublingual microcirculation with vessel density and flow parameters. Also skin perfusion maps (Laser Speckle Imaging) will be recorded. Blood and urine samples will also be used for measuring glycocalyx shedding products.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
Microcirculation assessment and laser speckle imaging are non-invasive procedures, and there are negligible risks. Blood tests will be used for measuring glycocalyx shedding products, this is an invasive procedure which may increase the risk of contamination, patient discomfort and in some extreme cases blood sample collection may be a burden on patient haemoglobin levels which is prone to decrease in critical patients. Assessment is essential for determining whether action is required to change our existing resuscitation regime for critically ill burned patients. If the results show that the current resuscitation regime is suboptimal, then motivation for changing the existing practice can lead to improved clinical care and a reduction in over- or under resuscitation in the ICU environment with its potential harmful effects.
The risks associated with participation can be considered negligible and the burden can be considered minimal in this observational study. The patients taking part in this study will have no direct benefit.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 30 patients admitted to the ICU with a severe burn ≥15% TBSA will be given standard resuscitation care and will be included
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
- Patients unlikely to survive >24 hours
- Decision not to initiate treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Measurement of microcirculatory perfusion alterations in severe burns patients during standard fluid resuscitation.
Time frame: 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
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.
1 secondary outcome
Microcirculatory perfusion alterations after administration of albumin.
Time frame: Changes in microcirculatory perfusion parameters will be measured directly after administration of albumin. This will be 12 hours after starting fluid resuscitation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Can Ince, Prof study director
Erasmus Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Microcirculation and Burns, run by Maasstad Hospital at 1 site in Netherlands.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 14 Oct 2020. 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 Netherlands. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of microcirculatory perfusion alterations in severe burns patients during standard fluid resuscitation. (time frame: 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). It is what the study was designed to measure, not a finding.
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 14 Oct 2020.