Severe Skin BurnsHEREBUSNCT05569499
Hematocrit Evolution in Severe Burns
An observational study of Severe Skin Burns, run by Centre Hospitalier Régional Metz-Thionville at 1 site in France.
Trial summary
Burn-induced shock is described as being superimposed on sterile shock. with an increase in capillary permeability affecting healthy and burnt tissue and explains the formation of a large third sector. Hematocrit is a criterion used historically to help adjust hydration in burn patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Skin Burns
- How many people
- 230 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2022to 1 Sep 2022
- 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: severly burned patients
Who may be able to join
- Burns over 20% of Total Body Surface Area (TBSA)
- Hospitalization in Mercy Hospital (France) Intensive Care Unit
Who cannot join
- Age under 18 y
- chemical, abrasion or radiation burns
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evolution of Hematocrit in Burn Patients as a Marker of Fluid Management During Acute Phase
Burn-induced shock is described as being superimposed on sterile shock. with an increase in capillary permeability affecting healthy and burnt tissue and explains the formation of a large third sector.
Hematocrit is a criterion used historically to help adjust hydration in burn patients. This measurement due to its characteristics and accessibility suggests that it could be a good marker for monitoring hemodynamic resuscitation. The evolution of this parameter in relation to the conduct of volume resuscitation is assessed.
Read more
Thus, a retrospective, monocentric study is conducted at the Metz Burn Centre (France).
Inclusion criteria were admission to the intensive care unit of the Metz hospital between 01/04/2014 and 31/12/2021, for a Total Body Surface Area (TBSA) of at least 20%. The exclusion criteria were the presence of a burn involving a TBSA under 20%, minor patients, chemical, abrasion or radiation burns. Several clinical and paraclinical parameters have been reported and in particular the volumes of hydration and the variations in hematocrit during the first 24 hours. Measures of linear association between two continuous variables are calculated by the Pearson coefficient. The threshold of statistical significance was defined as a p-value of <0.05.
Read the detailed description
Burn-induced shock is described as being superimposed on sterile shock. The inflammatory reaction secondary to tissue destruction leads to the release of multiple inflammatory mediators into the bloodstream, resulting in the development of systemic inflammatory response syndrome (SIRS). This is responsible for an increase in capillary permeability affecting healthy and burnt tissue and explains the formation of a large third sector.
The initial resuscitation of this state of shock differs from other management of shocked patients by the importance of its hypovolaemic side. Indeed, this is based on the evaluation of the filling needs through the Parkland formula defining the volume of hydration over twenty-four hours that should be administered. This guided and stereotyped haemodynamic resuscitation could lead to a state of fluid creep if it is not correctly monitored. Indeed, the importance of crystalloid solutions would lead to numerous complications such as pneumopathy or respiratory distress, cardiac failure or abdominal compartment syndrome. It is therefore necessary to adjust the fluid intake for the first twenty-four hours. This adjustment is made by means of various parameters including blood pressure and hourly diuresis. For some, the use of TEE, thermodilution or pulmonary artery catheterisation would allow more personalised and appropriate management.
Haematocrit is a criterion used historically to help adjust hydration in burn patients. Animal studies have shown it to be a good reflection of haemoconcentration caused by a burn. Haematocrit and haemoglobin levels change significantly downwards after a one litre saline filling in humans. The haematocrit has been shown to be a reliable reflection of hydration status in children and adults and can be used to assess the volume to be administered to correct dehydration states. Another criterion for monitoring haemodynamic resuscitation by haematocrit seems to be the availability of many biological tests in the initial phase of management of patients in shock. The measurement of haematocrit due to its characteristics and accessibility suggests that it could be a good marker for monitoring haemodynamic resuscitation in burn patients. The evolution of this parameter in relation to the conduct of volume resuscitation is assessed during the first twenty-four hours in severely burned patients.
A retrospective, monocentric study is conducted at the Metz Burn Centre (France). Various parameters were recorded: sex, age, weight (and its variations during the first 48 hours), height, TBSA, presence of cardiovascular comorbidities, IGS II, Baux Score, ABSI, BOBI, UBS score, origin of the burn, percentage of third degree, presence of inhalation, filling before admission and then hydration during the first 24 hours, the evolution of haematocrit, haemoglobin and albumin over the first 48 hours, hourly diuresis over the first 48 hours as well as the presence of mechanical ventilation (PAFI and its variations during the first 48 hours) or extra renal purification.
- Conditions
- Severe Skin Burns
- Medical subject headings
- Paresthesia
What is being measured
The primary outcome is the main question the study is designed to answer.
Hematocrit evolution
Hematocrit level measured between the eighth and twenty-fourth hour minus the hematocrit level on admission
Measured: 24 hours following patient admission in intensive care unit
Secondary outcomes (1)
Mortality in intensive care unit
mortality rate
Measured: at discharge of intensive care unit, average of 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2022
- Study start1 Jul 2022
- Primary completion1 Sep 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Skin BurnsStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional Metz-Thionville
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Serge LE TACON, MD, Principal investigator, CHR Metz Thionville Hopital de Mercy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05569499
- Sponsor's protocol ID
- 2022-13Obs-CHRMT
- Acronym
- HEREBUS
- Status last verified
- Sep 2022
- First submitted
- 30 Sep 2022
- Last updated
- 7 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evolution of Hematocrit in Burn Patients as a Marker of Fluid Management During Acute Phase
- ClinicalTrials.gov ID
- NCT05569499
- Acronym / sponsor ID
- HEREBUS / 2022-13Obs-CHRMT
- Conditions
- Severe Skin Burns
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional Metz-ThionvilleUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 6 Oct 2022 (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.
Burn-induced shock is described as being superimposed on sterile shock. with an increase in capillary permeability affecting healthy and burnt tissue and explains the formation of a large third sector.
Hematocrit is a criterion used historically to help adjust hydration in burn patients. This measurement due to its characteristics and accessibility suggests that it could be a good marker for monitoring hemodynamic resuscitation. The evolution of this parameter in relation to the conduct of volume resuscitation is assessed.
Thus, a retrospective, monocentric study is conducted at the Metz Burn Centre (France).
Inclusion criteria were admission to the intensive care unit of the Metz hospital between 01/04/2014 and 31/12/2021, for a Total Body Surface Area (TBSA) of at least 20%. The exclusion criteria were the presence of a burn involving a TBSA under 20%, minor patients, chemical, abrasion or radiation burns. Several clinical and paraclinical parameters have been reported and in particular the volumes of hydration and the variations in hematocrit during the first 24 hours. Measures of linear association between two continuous variables are calculated by the Pearson coefficient. The threshold of statistical significance was defined as a p-value of <0.05.
Detailed description
Burn-induced shock is described as being superimposed on sterile shock. The inflammatory reaction secondary to tissue destruction leads to the release of multiple inflammatory mediators into the bloodstream, resulting in the development of systemic inflammatory response syndrome (SIRS). This is responsible for an increase in capillary permeability affecting healthy and burnt tissue and explains the formation of a large third sector.
The initial resuscitation of this state of shock differs from other management of shocked patients by the importance of its hypovolaemic side. Indeed, this is based on the evaluation of the filling needs through the Parkland formula defining the volume of hydration over twenty-four hours that should be administered. This guided and stereotyped haemodynamic resuscitation could lead to a state of fluid creep if it is not correctly monitored. Indeed, the importance of crystalloid solutions would lead to numerous complications such as pneumopathy or respiratory distress, cardiac failure or abdominal compartment syndrome. It is therefore necessary to adjust the fluid intake for the first twenty-four hours. This adjustment is made by means of various parameters including blood pressure and hourly diuresis. For some, the use of TEE, thermodilution or pulmonary artery catheterisation would allow more personalised and appropriate management.
Haematocrit is a criterion used historically to help adjust hydration in burn patients. Animal studies have shown it to be a good reflection of haemoconcentration caused by a burn. Haematocrit and haemoglobin levels change significantly downwards after a one litre saline filling in humans. The haematocrit has been shown to be a reliable reflection of hydration status in children and adults and can be used to assess the volume to be administered to correct dehydration states. Another criterion for monitoring haemodynamic resuscitation by haematocrit seems to be the availability of many biological tests in the initial phase of management of patients in shock. The measurement of haematocrit due to its characteristics and accessibility suggests that it could be a good marker for monitoring haemodynamic resuscitation in burn patients. The evolution of this parameter in relation to the conduct of volume resuscitation is assessed during the first twenty-four hours in severely burned patients.
A retrospective, monocentric study is conducted at the Metz Burn Centre (France). Various parameters were recorded: sex, age, weight (and its variations during the first 48 hours), height, TBSA, presence of cardiovascular comorbidities, IGS II, Baux Score, ABSI, BOBI, UBS score, origin of the burn, percentage of third degree, presence of inhalation, filling before admission and then hydration during the first 24 hours, the evolution of haematocrit, haemoglobin and albumin over the first 48 hours, hourly diuresis over the first 48 hours as well as the presence of mechanical ventilation (PAFI and its variations during the first 48 hours) or extra renal purification.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- severly burned patients
Key inclusion criteria (2 listed)
- Burns over 20% of Total Body Surface Area (TBSA)
- Hospitalization in Mercy Hospital (France) Intensive Care Unit
Key exclusion criteria (2 listed)
- Age under 18 y
- chemical, abrasion or radiation burns
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
Hematocrit evolution
Time frame: 24 hours following patient admission in intensive care unit
Hematocrit level measured between the eighth and twenty-fourth hour minus the hematocrit level on admission
1 secondary outcome
Mortality in intensive care unit
Time frame: at discharge of intensive care unit, average of 14 days
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 7 Oct 2022.
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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.
Serge LE TACON, MD principal investigator
CHR Metz Thionville Hopital de Mercy
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 Severe Skin Burns, run by Centre Hospitalier Régional Metz-Thionville at 1 site in France.
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 2 inclusion and 2 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 7 Oct 2022. 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 France. 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?
Hematocrit evolution (time frame: 24 hours following patient admission in intensive care unit). 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 7 Oct 2022.