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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
28
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.
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.
Departement of Anesthesiology, Critical Care and Burn Unit; Saint-Louis hospital
Paris, France
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
Time frame: after 24 hours of admission.
Acetate, gluconate and lactate clearance respectively in patients receiving Plasmalyte® or Ringer lactate.
Arterial blood gas analysis
Time frame: 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
Time frame: 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
Time frame: Every day during 5 days
Incidence of AKI (according to the KDIGO definition)
urine output and serum creatinine
Time frame: Every day during 5 days
Sequential Organ Failure Assessment score
SOFA score calculation
Time frame: During the first 5 days of intensive care unit stay
mortality at day 28
Mortality will be collected
Time frame: At 28 day after admission
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