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临床试验/NCT00847977
NCT00847977终止3 期

Intérêt d'Utiliser Des solutés de Remplissage équilibrés à la Phase précoce d'un Traumatisme crânien Grave Pour Limiter l'Acidose hyperchlorémique

Nantes University Hospital1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2008年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
终止
入组人数
42
试验地点
1
主要终点
Incidence of hyperchloremic acidosis during the 2 first days of acute cranial traumatism.

研究概览

简要总结

isotonic NaCl serum is the first intent solution for infusion during the initial phase of reanimation for an acute cranial traumatism.

However, its use can trigger an hyperchloremic metabolic acidosis, what could be deleterious for the future of this patient.

Isofundine present all charateristics to be use in this indication: pharmacokinetic and pharmacodynamic similar to the physiologic serum, iso-osmolarity to plasma, no glucose provision and no interaction with hemostasis.

详细描述

Participation in the study lasts 7 days per patient.

Both solutions are crystalloids who received MA in France for ISOFUNDINE, MA in Germany with pending MA in France for TETRASPAN, including an indication for infusion. Both solutions are consistent with the recommendations of intensive care of a traumatized brain: iso-osmolar and without glucose. The study is an emergency: the resuscitation of a head injury, for which the plasma by crystalloids may be delayed.

J0: Day of Inclusion

On arrival at the emergency operating room at the diagnosis of a serious head injury alone, the anaesthetist that supports the patient in an initial phase includes the patient in the study.

A H0, it is holding the patient randomization and continued his rehabilitation with the lot of fluids allocated. If he wants to use macro-molecules, it may use HydroxyEhtylAmidons(HEA). Each batch assigned to a patient includes a crystalloids and HEA: witnesses arm includes saline solution and the HEAfusine while the interventional arm includes Isofundine and tetraspan. These treatment are indistinguishable and both provided by the laboratory Braun. They will be kept in operating emergency to be the most readily available, upon arrival of the patient. If the health of the patient requires a refill crystalloids emergency even before randomization did not take place, the clinician uses originally Saline and starts the protocol as soon as possible as soon as the patient him can take the few minutes needed to achieve inclusion. The first biological assessment include the determination of natremia, of kaliemia, of magnesemia, the ionized calcium, the lactatemia of albumin, the osmolarity of plasma and blood gases. These strengths are in Biological standard of care of a traumatized brain.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Glasgow < or equal to 8
  • Patient > 18 years old

排除标准

  • Polytraumatism
  • Pregnancy
  • Patient under guardianship
  • renal insufficiency, hypokaliemia, hypocalcemia

研究组 & 干预措施

2

Experimental

Isofundine - Tetraspan

干预措施: use of balanced crystalloids fluid and macromolecular fluid (Drug)

1

Active Comparator

Heafusine - Physiologic serum

干预措施: use of a non balced fluid and of a macromolecular fluid (Drug)

结局指标

主要结局

Incidence of hyperchloremic acidosis during the 2 first days of acute cranial traumatism.

时间窗: J1 and J2

次要结局

  • Incidence of hypokaliemia and hypocalcemia(J1 and J2)
  • Study of treatment effect on the evolution of intracranil pressure.(J1 and J2)

研究者

申办方类型
Other

研究点 (1)

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