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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
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.


Condition or disease Intervention/treatment Phase
Severe Burns Fluid Resuscitation Drug: Plasmalyte Drug: Ringer lactate Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Allocation: Randomized
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: Single (Participant)
Masking Description: the crystalloid infusion solutions will be introduce in Opabag
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns

Arm Intervention/treatment
Experimental: Plasmalyte®
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

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. Incidence of AKI (according to the KDIGO definition) [ Time Frame: Every day during 5 days ]
    urine output and serum creatinine

  5. Sequential Organ Failure Assessment score [ Time Frame: During the first 5 days of intensive care unit stay ]
    SOFA score calculation

  6. mortality at day 28 [ Time Frame: At 28 day after admission ]
    Mortality will be collected



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
Contact: Matthieu Dr Legrand, MD, PhD 01 42 49 93 94 matthieu.m.legrand@gmail.com

Locations
France
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      
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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

Publications:
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03118362     History of Changes
Other Study ID Numbers: P160502
First Posted: April 18, 2017    Key Record Dates
Last Update Posted: September 27, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Burns
Critically ill
Acid-Base status

Additional relevant MeSH terms:
Burns
Wounds and Injuries
Plasma-lyte 148
Pharmaceutical Solutions
Ophthalmic Solutions