Ignite Creation Date:
2024-07-17 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06469970
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-24
First Post:
2024-06-14
Brief Title:
Evolution of the Initial Distribution Volume of Glucose in the Severe Burned Adults
Sponsor:
Centre Hospitalier Régional Metz-Thionville
Organization:
Centre Hospitalier Régional Metz-Thionville
Study Overview
Official Title:
INDICIA Evolution of the Initial Distribution Volume of Glucose in the Severe Burned Adults
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INDICIA
Brief Summary:
This is a low interventional monocentric trial Phase IV aiming to describe the evolutionary profile of the initial volume of glucose distribution IDVG during the first four days of management of severely burned patient
Detailed Description:
In the early phase severe burns induce a state of hypovolaemic shock linked to inflammation and a capillary leak syndrome responsible for the formation of a voluminous third sector Initial resuscitation of burn patients is based on an assessment of filling requirements using the Parkland formula which takes into account the patients weight and the percentage of burned skin surface This haemodynamic resuscitation oscillates between a risk of underfilling responsible for hypovolaemia with low cardiac output and leading to excess mortality and a state of hydric hyperinflation responsible for numerous complications such as respiratory distress cardiac failure abdominal compartment syndrome and even excess mortality The necessary adaptation of vascular filling rates is usually achieved by monitoring clinical parameters such as diuresis or biological parameters such as arterial lactate or haematocrit More advanced haemodynamic monitoring may be applied in addition but the targets chosen and their numerical objectives remain to be validated Due to the burn-induced capillary leak syndrome quantification of extracellular intra- and extravascular fluid volume ECFV could be a relevant marker of fluid overload status in severely burned patients ECFV can be estimated using intravenous glucose Glucose is distributed throughout the extracellular fluid compartment within a few minutes and defines an initial volume of glucose distribution IDVG proportional to the ECFV This measurement has been validated in healthy individuals and in various pathological conditions In intensive care patients the values are between 31 and 48 Lm2
To the best of our knowledge no study has assessed variations in ECV measured by the LVDI in severely burned patients in the early phase of intensive care Understanding these variations could make a definite contribution to the adaptation of perfused fluid volumes
To the best of our knowledge no study has assessed variations in ECV measured by the LVDI in severely burned patients in the early phase of intensive care Understanding these variations could make a definite contribution to the adaptation of perfused fluid volumes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None