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Severe BurnsPhase 3CARENCT03118362

Fluid Resuscitation in Burn Patients

A Phase 3 study testing Plasmalyte and Ringer lactate in people with Severe Burns and Fluid Resuscitation, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Severe Burns, Fluid Resuscitation
What is being tested?
Plasmalyte and Ringer lactate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
1 siteFrance
Study dates
9 Aug 2017to 2 Dec 2019
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Decline to participate
  • pregnancy
  • Metabolic alkalosis (excess of base> 5mmol / L)
  • legal obstacle to participate

Trial locations and contacts

1 site in 1 country.

France1 site

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

    Paris, 75010

Other trials in France

About this study

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

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.

Read the 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.

Being tested
Plasmalyte, Ringer lactate
Keywords
Burns, Critically ill, Acid-Base status
Medical subject headings
Burns, Critical Illness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlasmalyteDrug

    Also called PLASMALYTE VIAFLO

    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.

  • Ringer lactateDrug

    Also called RINGER LACTATE VIAFLO

    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.

Study groups in NCT03118362
Study groupRoleWhat they receive
Plasmalyte®ExperimentalPlasmalyte® 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.
Receives: Drug: Plasmalyte
Ringer Lactate®ExperimentalRinger Lactate® is a balanced solution containing a low chloride concentration (i.e. 111mmol/L), it also contains lactate (29 mmol/L) as buffer solutions.
Receives: Drug: Ringer lactate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: after 24 hours of admission.

Secondary outcomes (6)

  1. Acetate, gluconate and lactate clearance respectively in patients receiving Plasmalyte® or Ringer lactate.

    Arterial blood gas analysis

    Measured: Every 6 hours for 48 hours, then every 12 hours for acid-base status during 5 days.

  2. acid-base status and strong ion difference after 24 hours of Plasmalyte® or Ringer lactate infusion

    Arterial blood gas analysis

    Measured: Every 6 hours for 48 hours, then every 12 hours for acid-base status during 5 days.

  3. Occurrence of cardiac dysfunction, defined as altered left ventricular ejection fraction(<50%)

    Trans-thoracic or trans-esophageal ultrasound

    Measured: Every day during 5 days

  4. Incidence of AKI (according to the KDIGO definition)

    urine output and serum creatinine

    Measured: Every day during 5 days

  5. Sequential Organ Failure Assessment score

    SOFA score calculation

    Measured: During the first 5 days of intensive care unit stay

  6. mortality at day 28

    Mortality will be collected

    Measured: At 28 day after admission

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2017
  2. Study start9 Aug 2017
  3. Primary completion12 Sep 2018
  4. Study completion2 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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 blind
Who is masked
Participant
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03118362
Sponsor's protocol ID
P160502
Acronym
CARE
Status last verified
Dec 2019
First submitted
13 Apr 2017
Last updated
13 Dec 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 24318694

  • 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.

    PubMed 22470070

  • 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.

    PubMed 24335444

  • 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.

    PubMed 21235742

  • 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.

    PubMed 19115651

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Plasmalyte and Ringer lactate in people with Severe Burns and Fluid Resuscitation, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03118362, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2019.

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