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临床试验/NCT00995839
NCT00995839已完成2 期

Vasopressin Receptor Agonists in Septic Shock: Effects on Microcirculation

University of Roma La Sapienza1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2008年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Systemic hemodynamic and Microcirculatory flow index of small and medium vessels (MFI)

研究概览

简要总结

The present study was conducted as a prospective, randomized study to investigate the effects of vasopressin receptor agonists terlipressin and vasopressin on systemic hemodynamics and microcirculation in patients with catecholamine-dependent septic shock.

详细描述

60 septic shock patients requiring norepinephrine to maintain mean arterial pressure between 65 and 75 mmHg despite adequate volume resuscitation will be enrolled in the study. After an initial hemodynamic resuscitation aimed at achieve a mean arterial pressure between 65 and 75 mmHg and normovolemia, patients will be randomly allocated to be treated with either a) intravenous administration of terlipressin 1 µg∙kg-1∙h-1 for 6 hrs, b) intravenous administration of arginine vasopressin 0.04 UI∙min-1 for 6 hrs, c) intravenous administration of terlipressin bolus dose of 0.5 mg (each n = 20). In all groups open label norepinephrine will be additionally administered to maintain a mean arterial pressure (MAP) between 65 and 75 mmHg, if necessary. Data from right heart catheterization and sublingual microvascular network will be obtained just before randomization (baseline) and then after 6 hours in the vasopressin, terlipressin infusion and terlipressin bolus groups.

The sublingual microvascular network will be studied using the sidestream dark field (SDF)imaging. The device will be applied on the lateral side of the tongue, in an area approximately 2-4 cm from the tip of the tongue. Sequences of 10 secs from eight adjacent areas will be recorded on disk using a personal computer. These sequences will be later analyzed by an investigator blinded to the patient's diagnosis and therapy.

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
Triple (Participant, Care Provider, 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

  • Clinical diagnosis of septic shock
  • Vasopressor support to maintain mean arterial pressure (MAP) between 65 and 75 mmHg despite adequate volume resuscitation (pulmonary artery occlusion pressure = 13-18 mmHg and central venous pressure = 8-12 mmHg)

排除标准

  • Pregnancy
  • Age < 18 years
  • Present or suspected acute mesenteric ischemia
  • Vasospastic diathesis (e.g. Raynaud's syndrome or related diseases)

研究组 & 干预措施

continuous terlipressin

Experimental

干预措施: continuous infusion of terlipressin (Drug)

vasopressin

Experimental

干预措施: Arginine vasopressin (Drug)

terlipressin bolus dose

Experimental

干预措施: terlipressin bolus administration (Drug)

结局指标

主要结局

Systemic hemodynamic and Microcirculatory flow index of small and medium vessels (MFI)

时间窗: over a period of 6 hrs from the time of randomization

Oxygen transport variables

时间窗: over a period of 6 from the time of randomization

次要结局

  • Acid-base homeostasis(over a period of 6 hrs from the time of randomization)
  • Functional capillary density (mm/mm2) (FCD)(over a period of 6 hrs from the time of randomization)
  • De Backer score(over a period of 6 hrs from the time of randomization)
  • Perfused Vessel Density (PVD) (mm/mm2)(over a period of 6 hrs from the time of randomization)
  • Proportion of Perfused vessels (%) (PPV)(over a period of 6 hrs from the time of randomization)

研究者

发起方
University of Roma La Sapienza
申办方类型
Other

研究点 (1)

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