Severe Burns, Fluid Resuscitation
Conditions
Keywords
Burns, Critically ill, Acid-Base status
Brief summary
Balanced solutions with low chloride concentration could represent an alternative to high chloride concentration solutions. Such balanced solutions contain other acid as buffers (i.e. acetate and/or gluconate). However, acetate has been associated with alteration of cardiac function when used as buffer in dialysate when high acetate concentrations are used and could promote the development of metabolic acidosis if it accumulates. Therefore, the safety of such solutions remains poorly explored. Because critically ill patients receive large amount of fluid during the early phase of resuscitation, large amount of acetate are to be administrated if such solutions are used. While acetate-containing solutions have been suggested to be safe in this setting, studies are still lacking regarding clearance and accumulation in critically ill patients. It is expected to include 28 patients, the objective to analyze the data of 20 patients.
Detailed description
The main objectives of the study is 1) to determine whether Plasmalyte® promote the development of metabolic acidosis in comparison with an acetate-free balanced solutions: Ringer lactate (chloride concentration of 111 mmol/L) and 2) to determine Acetate & gluconate clearance during fluid resuscitation of severely burn patients Plasmalyte® (chloride concentration of 98 mmol/L) . Severely burn patients will be randomized to receive Plasmalyte® or Ringer Lactate for initial fluid resuscitation during the first 5 days following admission.
Interventions
DRUGPlasmalyte
Parenteral administration of Plasmalyte initiated immediately after inclusion at a dosage of 4 ml / kg per percentage area of skin burned for the first 24 hours after burn injury and adjusted based on hemodynamic monitoring. Each patient will receive this solution up to 5 days.
DRUGRinger lactate
Parenteral administration of Ringer lactate initiated immediately after inclusion at a dosage of 4 ml / kg per percentage area of skin burned for the first 24 hours after burn injury and adjusted based on hemodynamic monitoring. Each patient will receive this solution up to 5 days.
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
the crystalloid infusion solutions will be introduce in Opabag
Intervention model description
Plasmalyte® is a balanced solution containing a low chloride concentration (i.e. 98 mmol/L) which may overcome overwhelm the potential risks associated with hyperchloremic solutions. Plasmalyte® also contains acetate (27 mmol/L) and gluconate (23 mmol/L) as buffer solutions. Ringer Lactate® is also a balanced solution containing a low chloride concentration (i.e. 111 mmol/L)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients over 18 years * TBSA\>30% * Admission to an intensive care unit within 12 hours after burn injury * Signed informed consent to Patient / Parent / ( Inclusion in Emergency and Consent is Collected) * social Insurance cover
Exclusion criteria
* Decline to participate * pregnancy * Metabolic alkalosis (excess of base\> 5mmol / L) * legal obstacle to participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The main endpoint is to compare the base deficit in patients receiving Plasmalyte® or Ringer lactate after 24 hours of admission. | after 24 hours of admission. | Arterial blood gas analysis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| acid-base status and strong ion difference after 24 hours of Plasmalyte® or Ringer lactate infusion | Every 6 hours for 48 hours, then every 12 hours for acid-base status during 5 days. | Arterial blood gas analysis |
| Occurrence of cardiac dysfunction, defined as altered left ventricular ejection fraction(<50%) | Every day during 5 days | Trans-thoracic or trans-esophageal ultrasound |
| Acetate, gluconate and lactate clearance respectively in patients receiving Plasmalyte® or Ringer lactate. | Every 6 hours for 48 hours, then every 12 hours for acid-base status during 5 days. | Arterial blood gas analysis |
| Sequential Organ Failure Assessment score | During the first 5 days of intensive care unit stay | SOFA score calculation |
| mortality at day 28 | At 28 day after admission | Mortality will be collected |
| Incidence of AKI (according to the KDIGO definition) | Every day during 5 days | urine output and serum creatinine |
Countries
France
Outcome results
None listed