Fluid Resuscitation in Burn Patients

Phase 3

Completed

• Conditions: Severe Burns; Fluid Resuscitation
• Interventions: Drug: Plasmalyte; Drug: Ringer lactate

• Registration Number: NCT03118362
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2017-04-13
• Study First Submitted QC: 2017-04-13
• Study First Posted: 2017-04-18
• Study Start: 2017-08-09
• Primary Completion: 2018-09-12
• Status Verified: 2019-12
• Study Completion: 2019-12-02
• Last Update Submitted: 2019-12-12
• Last Update Posted: 2019-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Plasmalyte®	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.
Ringer Lactate®	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.

Primary Outcome Measures

Name	Time	Method
The main endpoint is to compare the base deficit in patients receiving Plasmalyte® or Ringer lactate after 24 hours of admission.	after 24 hours of admission.	Arterial blood gas analysis

Secondary Outcome Measures

Name	Time	Method
Acetate, gluconate and lactate clearance respectively in patients receiving Plasmalyte® or Ringer lactate.	Every 6 hours for 48 hours, then every 12 hours for acid-base status during 5 days.	Arterial blood gas analysis
Sequential Organ Failure Assessment score	During the first 5 days of intensive care unit stay	SOFA score calculation
acid-base status and strong ion difference after 24 hours of Plasmalyte® or Ringer lactate infusion	Every 6 hours for 48 hours, then every 12 hours for acid-base status during 5 days.	Arterial blood gas analysis
mortality at day 28	At 28 day after admission	Mortality will be collected
Occurrence of cardiac dysfunction, defined as altered left ventricular ejection fraction(<50%)	Every day during 5 days	Trans-thoracic or trans-esophageal ultrasound
Incidence of AKI (according to the KDIGO definition)	Every day during 5 days	urine output and serum creatinine

Trial Locations

Locations (1)

Departement of Anesthesiology, Critical Care and Burn Unit; Saint-Louis hospital; 🇫🇷 Paris, France