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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

France1 site
  • CHR Metz-Thionville/Hopital de Mercy

    Metz, 57085

Other trials in France

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.

Medical subject headings
Paresthesia

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)
  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.

  1. First posted6 Oct 2022
  2. Study start1 Jul 2022
  3. Primary completion1 Sep 2022
  4. Study completion1 Sep 2022

Resources

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)
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

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.

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