Fluid Resuscitation in Burn Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Clearance of Acetate During Fluid Resuscitation of Critically Ill Burn Patients: The CARE Trial.

Conditions
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Severe Burns, Fluid Resuscitation

Intervention / Treatment
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* Drug: Plasmalyte
* Drug: Ringer lactate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Plasmalyte®<br>Plasmalyte® is a balanced solution containing a low chloride concentration (i.e. 98 mmol/L), it also contains acetate (27 mmol/L) and gluconate (23 mmol/L) as buffer solutions. | Drug: Plasmalyte<br>* 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.<br>* Other names: PLASMALYTE VIAFLO;|
| Experimental: Ringer Lactate®<br>Ringer Lactate® is a balanced solution containing a low chloride concentration (i.e. 111mmol/L), it also contains lactate (29 mmol/L) as buffer solutions. | Drug: Ringer lactate<br>* 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.<br>* Other names: RINGER LACTATE VIAFLO;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The main endpoint is to compare the base deficit in patients receiving Plasmalyte® or Ringer lactate after 24 hours of admission. | Arterial blood gas analysis | after 24 hours of admission. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acetate, gluconate and lactate clearance respectively in patients receiving Plasmalyte® or Ringer lactate. | Arterial blood gas analysis | Every 6 hours for 48 hours, then every 12 hours for acid-base status during 5 days. | 
| acid-base status and strong ion difference after 24 hours of Plasmalyte® or Ringer lactate infusion | Arterial blood gas analysis | Every 6 hours for 48 hours, then every 12 hours for acid-base status during 5 days. | 
| Occurrence of cardiac dysfunction, defined as altered left ventricular ejection fraction(<50%) | Trans-thoracic or trans-esophageal ultrasound | Every day during 5 days | 
| Incidence of AKI (according to the KDIGO definition) | urine output and serum creatinine | Every day during 5 days | 
| Sequential Organ Failure Assessment score | SOFA score calculation | During the first 5 days of intensive care unit stay | 
| mortality at day 28 | Mortality will be collected | At 28 day after admission | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Burns, Critically ill, Acid-Base status