Fluid Resuscitation in Burn Patients (CARE)
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|ClinicalTrials.gov Identifier: NCT03118362|
Recruitment Status : Recruiting
First Posted : April 18, 2017
Last Update Posted : September 27, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Severe Burns Fluid Resuscitation||Drug: Plasmalyte Drug: Ringer lactate||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||28 participants|
|Intervention Model:||Parallel Assignment|
|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)
|Masking Description:||the crystalloid infusion solutions will be introduce in Opabag|
|Official Title:||Clearance of Acetate During Fluid Resuscitation of Critically Ill Burn Patients: The CARE Trial.|
|Actual Study Start Date :||August 9, 2017|
|Estimated Primary Completion Date :||September 9, 2018|
|Estimated Study Completion Date :||October 9, 2018|
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.
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.
Other Name: PLASMALYTE VIAFLO
Experimental: Ringer Lactate®
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
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.
Other Name: RINGER LACTATE VIAFLO
- The main endpoint is to compare the base deficit in patients receiving Plasmalyte® or Ringer lactate after 24 hours of admission. [ Time Frame: after 24 hours of admission. ]Arterial blood gas analysis
- Acetate, gluconate and lactate clearance respectively in patients receiving Plasmalyte® or Ringer lactate. [ Time Frame: Every 6 hours for 48 hours, then every 12 hours for acid-base status during 5 days. ]Arterial blood gas analysis
- acid-base status and strong ion difference after 24 hours of Plasmalyte® or Ringer lactate infusion [ Time Frame: 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%) [ Time Frame: Every day during 5 days ]Trans-thoracic or trans-esophageal ultrasound
- Incidence of AKI (according to the KDIGO definition) [ Time Frame: Every day during 5 days ]urine output and serum creatinine
- Sequential Organ Failure Assessment score [ Time Frame: During the first 5 days of intensive care unit stay ]SOFA score calculation
- mortality at day 28 [ Time Frame: At 28 day after admission ]Mortality will be collected
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03118362
|Contact: Matthieu Dr Legrand, MD, PhD||01 42 49 93 email@example.com|
|Departement of Anesthesiology, Critical Care and Burn Unit; Saint-Louis hospital||Recruiting|
|Paris, France, 75010|
|Contact: Mathieu LEGRAND, MD, PhD 01 42 49 93 94|
|Principal Investigator:||Matthieu Legrand, MD, PhD||Departement of Anesthesiology, Critical Care and Burn Unit; Saint-Louis hospital, 1 Avenue Claude Vellefaux, 75010, Paris & University Paris Diderot|