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Completed

NCT Number: NCT03118362

Fluid Resuscitation in Burn Patients

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.

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Key information

Conditions

Severe Burns Burns Critical Illness Disease Attributes Fluid Resuscitation Pathologic Processes Pathological Conditions, Signs and Symptoms Wounds and Injuries

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Departement of Anesthesiology, Critical Care and Burn Unit; Saint-Louis hospital

Paris, 75010, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PlasmaLyte

Drug

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 names: PLASMALYTE VIAFLO

Ringer lactate

Drug

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 names: RINGER LACTATE VIAFLO

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: CARE

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Apr 18, 2017
Registry last updated
Dec 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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