Clinical trial NCT03118362: Fluid Resuscitation in Burn Patients
Official title: Clearance of Acetate During Fluid Resuscitation of Critically Ill Burn Patients: The CARE Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Severe Burns
Fluid Resuscitation
Keywords: Burns
Critically ill
Acid-Base status
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2017-04-18
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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)
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The main endpoint is to compare the base deficit in patients receiving Plasmalyte® or Ringer lactate after 24 hours of admission.
timeFrame: after 24 hours of admission.
Secondary outcomes:
measure: Acetate, gluconate and lactate clearance respectively in patients receiving Plasmalyte® or Ringer lactate.
timeFrame: Every 6 hours for 48 hours, then every 12 hours for acid-base status during 5 days.
measure: acid-base status and strong ion difference after 24 hours of Plasmalyte® or Ringer lactate infusion
timeFrame: Every 6 hours for 48 hours, then every 12 hours for acid-base status during 5 days.
measure: Occurrence of cardiac dysfunction, defined as altered left ventricular ejection fraction(<50%)
timeFrame: Every day during 5 days
measure: Incidence of AKI (according to the KDIGO definition)
timeFrame: Every day during 5 days
measure: Sequential Organ Failure Assessment score
timeFrame: During the first 5 days of intensive care unit stay
measure: mortality at day 28
timeFrame: At 28 day after admission
Other outcomes:
Locations:
city: Paris
country: France
facility: Departement of Anesthesiology, Critical Care and Burn Unit; Saint-Louis hospital
Study officials:
affiliation: Departement of Anesthesiology, Critical Care and Burn Unit; Saint-Louis hospital, 1 Avenue Claude Vellefaux, 75010, Paris & University Paris Diderot
name: Matthieu Legrand, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.