Fluid Resuscitation in Burn Patients (CARE)
Primary Purpose
Severe Burns, Fluid Resuscitation
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Plasmalyte
Ringer lactate
Sponsored by
About this trial
This is an interventional treatment trial for Severe Burns focused on measuring Burns, Critically ill, Acid-Base status
Eligibility Criteria
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
Sites / Locations
- Departement of Anesthesiology, Critical Care and Burn Unit; Saint-Louis hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Plasmalyte®
Ringer Lactate®
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Acetate, gluconate and lactate clearance respectively in patients receiving Plasmalyte® or Ringer lactate.
Arterial blood gas analysis
acid-base status and strong ion difference after 24 hours of Plasmalyte® or Ringer lactate infusion
Arterial blood gas analysis
Occurrence of cardiac dysfunction, defined as altered left ventricular ejection fraction(<50%)
Trans-thoracic or trans-esophageal ultrasound
Incidence of AKI (according to the KDIGO definition)
urine output and serum creatinine
Sequential Organ Failure Assessment score
SOFA score calculation
mortality at day 28
Mortality will be collected
Full Information
NCT ID
NCT03118362
First Posted
April 13, 2017
Last Updated
December 12, 2019
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT03118362
Brief Title
Fluid Resuscitation in Burn Patients
Acronym
CARE
Official Title
Clearance of Acetate During Fluid Resuscitation of Critically Ill Burn Patients: The CARE Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
August 9, 2017 (Actual)
Primary Completion Date
September 12, 2018 (Actual)
Study Completion Date
December 2, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Burns, Fluid Resuscitation
Keywords
Burns, Critically ill, Acid-Base status
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
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
Participant
Masking Description
the crystalloid infusion solutions will be introduce in Opabag
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Plasmalyte®
Arm Type
Experimental
Arm Description
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.
Arm Title
Ringer Lactate®
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Plasmalyte
Other Intervention Name(s)
PLASMALYTE VIAFLO
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Ringer lactate
Other Intervention Name(s)
RINGER LACTATE VIAFLO
Intervention Description
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.
Primary Outcome Measure Information:
Title
The main endpoint is to compare the base deficit in patients receiving Plasmalyte® or Ringer lactate after 24 hours of admission.
Description
Arterial blood gas analysis
Time Frame
after 24 hours of admission.
Secondary Outcome Measure Information:
Title
Acetate, gluconate and lactate clearance respectively in patients receiving Plasmalyte® or Ringer lactate.
Description
Arterial blood gas analysis
Time Frame
Every 6 hours for 48 hours, then every 12 hours for acid-base status during 5 days.
Title
acid-base status and strong ion difference after 24 hours of Plasmalyte® or Ringer lactate infusion
Description
Arterial blood gas analysis
Time Frame
Every 6 hours for 48 hours, then every 12 hours for acid-base status during 5 days.
Title
Occurrence of cardiac dysfunction, defined as altered left ventricular ejection fraction(<50%)
Description
Trans-thoracic or trans-esophageal ultrasound
Time Frame
Every day during 5 days
Title
Incidence of AKI (according to the KDIGO definition)
Description
urine output and serum creatinine
Time Frame
Every day during 5 days
Title
Sequential Organ Failure Assessment score
Description
SOFA score calculation
Time Frame
During the first 5 days of intensive care unit stay
Title
mortality at day 28
Description
Mortality will be collected
Time Frame
At 28 day after admission
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthieu Legrand, MD, PhD
Organizational Affiliation
Departement of Anesthesiology, Critical Care and Burn Unit; Saint-Louis hospital, 1 Avenue Claude Vellefaux, 75010, Paris & University Paris Diderot
Official's Role
Principal Investigator
Facility Information:
Facility Name
Departement of Anesthesiology, Critical Care and Burn Unit; Saint-Louis hospital
City
Paris
ZIP/Postal Code
75010
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
24318694
Citation
Hahn RG. Should anaesthetists stop infusing isotonic saline? Br J Anaesth. 2014 Jan;112(1):4-6. doi: 10.1093/bja/aet292. No abstract available.
Results Reference
background
PubMed Identifier
22470070
Citation
Shaw AD, Bagshaw SM, Goldstein SL, Scherer LA, Duan M, Schermer CR, Kellum JA. Major complications, mortality, and resource utilization after open abdominal surgery: 0.9% saline compared to Plasma-Lyte. Ann Surg. 2012 May;255(5):821-9. doi: 10.1097/SLA.0b013e31825074f5.
Results Reference
background
PubMed Identifier
24335444
Citation
Zhou F, Peng ZY, Bishop JV, Cove ME, Singbartl K, Kellum JA. Effects of fluid resuscitation with 0.9% saline versus a balanced electrolyte solution on acute kidney injury in a rat model of sepsis*. Crit Care Med. 2014 Apr;42(4):e270-8. doi: 10.1097/CCM.0000000000000145.
Results Reference
background
PubMed Identifier
21235742
Citation
Davies PG, Venkatesh B, Morgan TJ, Presneill JJ, Kruger PS, Thomas BJ, Roberts MS, Mundy J. Plasma acetate, gluconate and interleukin-6 profiles during and after cardiopulmonary bypass: a comparison of Plasma-Lyte 148 with a bicarbonate-balanced solution. Crit Care. 2011;15(1):R21. doi: 10.1186/cc9966. Epub 2011 Jan 14.
Results Reference
background
PubMed Identifier
19115651
Citation
Morgan TJ, Power G, Venkatesh B, Jones MA. Acid-base effects of a bicarbonate-balanced priming fluid during cardiopulmonary bypass: comparison with Plasma-Lyte 148. A randomised single-blinded study. Anaesth Intensive Care. 2008 Nov;36(6):822-9. doi: 10.1177/0310057X0803600611. Erratum In: Anaesth Intensive Care. 2012 Jul;40(4):719.
Results Reference
background
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Fluid Resuscitation in Burn Patients
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