- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05569499
Hematocrit Evolution in Severe Burns (HEREBUS)
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.
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.
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Metz, France, 57085
- CHR Metz-Thionville/Hopital de Mercy
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Burns over 20% of Total Body Surface Area (TBSA)
- Hospitalization in Mercy Hospital (France) Intensive Care Unit
Exclusion Criteria:
- Age under 18 y
- chemical, abrasion or radiation burns
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hematocrit evolution
Time Frame: 24 hours following patient admission in intensive care unit
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Hematocrit level measured between the eighth and twenty-fourth hour minus the hematocrit level on admission
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24 hours following patient admission in intensive care unit
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Mortality in intensive care unit
Time Frame: at discharge of intensive care unit, average of 14 days
|
mortality rate
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at discharge of intensive care unit, average of 14 days
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Collaborators and Investigators
Investigators
- Principal Investigator: Serge LE TACON, MD, CHR Metz Thionville Hopital de Mercy
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022-13Obs-CHRMT
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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