Clearance of Acetate During Fluid Resuscitation of Critically Ill Burn Patients: The CARE Trial.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- The main endpoint is to compare the base deficit in patients receiving Plasmalyte® or Ringer lactate after 24 hours of admission.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
the crystalloid infusion solutions will be introduce in Opabag
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Decline to participate
- •pregnancy
- •Metabolic alkalosis (excess of base> 5mmol / L)
- •legal obstacle to participate
研究组 & 干预措施
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.
干预措施: Plasmalyte (Drug)
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.
干预措施: Ringer lactate (Drug)
结局指标
主要结局
The main endpoint is to compare the base deficit in patients receiving Plasmalyte® or Ringer lactate after 24 hours of admission.
时间窗: after 24 hours of admission.
Arterial blood gas analysis
次要结局
- 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.)
- Sequential Organ Failure Assessment score(During the first 5 days of intensive care unit stay)
- 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.)
- mortality at day 28(At 28 day after admission)
- Occurrence of cardiac dysfunction, defined as altered left ventricular ejection fraction(<50%)(Every day during 5 days)
- Incidence of AKI (according to the KDIGO definition)(Every day during 5 days)