NCT01271114终止3 期
Hypertonic Saline and Terlipressin Linked To an Early Goal-Driven Protocol for Septic Shock or Sepsis-Associated Hypotension: A Pilot Trial (HYSATESS)
Hospital General de Ciudad Real1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2012年6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
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- MOD (Multiple Organ Dysfunction) Score
研究概览
简要总结
In hypotensive septic patients with controlled source, an hemodynamic management protocol including hypertonic saline (HS)and terlipressin improves MOD (Multiple Organ Dysfunction) Score by at least 3 points compared to the use of physiologic saline and norepinephrine.
The appropriate design for this trial would be factorial. For the time being, will consider de intervention as a whole unit for this pilot study. In the future an appropriately sized factorial multicentric study shall be necessary.
Other goals of the pilot study:
- HS restores preload parameters adequately
- HS associated with terlipressin normalizes blood pressure in septic shock
- HS associated with terlipressin maintains plasma sodium levels 130-155mEq/L
- There is an inverse relationship between plasma sodium and procalcitonin levels
- HS increases plasma levels of vasopressin (AVP)
- HS rises levels of cortisol but not of adrenocorticotropic hormone (ACTH)
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Criteria of SIRS: at least 2 of 4:
- •Temperature > 38 °c or < 36 ° C
- •More than 90 bpm heart rate
- •Respiratory rate more than 20rpm or PaCO2 less than 32 mm Hg or patient in mechanical ventilation
- •Less than 4000/ mm³ or more than 12000/mm³, or more than 10% leukocyte bands (immature)
- •Septic source known demonstrated (or at least of high probability) and controlled (if it is controllable)
- •Hematocrit 25% or higher and/or hemoglobin 8 g/dL or higher. If necessary, transfuse RBCs to meet this criteria
- •MAP less than 70 mm Hg. Note there is no requirement for adequate preload evidence
排除标准
- •Hypernatremia at base-line of 155 mEq/L or greater Hyponatremia at base-line less than 130mEq / L
- •Prior endocrine disease affecting to the adrenal-pituitary axis.
- •Intracranial Hypertension, brain tumor, seizures, head trauma
- •Coronary Artery Disease active over the past year; or evidence of "myocardium at risk" by exercise stress test, pharmacological or positive gammagraphy last year without intervention
- •Pregnancy
- •Liver disease Child C, End-Stage-Renal-Disease
- •Under the age of 18
- •Patients with order "do not resuscitate" or with minimal chances to survive
研究组 & 干预措施
Hypertonic Saline and Terlipressin
Experimental
干预措施: Hypertonic Saline and Terlipressin (Drug)
Normal Saline and norepinephrine
Active Comparator
干预措施: Normal saline and norepinephrine (Drug)
结局指标
主要结局
MOD (Multiple Organ Dysfunction) Score
时间窗: daily, as long as the patient stays in the ICU
次要结局
- Hypertonic Saline restores IV fluid response parameters (Pulse Pressure Variation or Systolic Volume Variation) adequately(First 48 hours)
- Hypertonic Saline associated with terlipressin maintains plasma sodium levels 130-155mEq/L(As long as Hypertonic saline plus terlipressin are in use and one week later)
- There is an inverse relationship between plasma sodium and plasma procalcitonin levels measured by a negative Pearson coefficient(As long as the patient stays in the ICU)
- Hypertonic Saline associated with terlipressin normalizes blood pressure in septic shock(First 48 hours)
- Hypertonic Saline boluses increases plasma levels of vasopressin (AVP)(First week in ICU)
- Hypertonic Saline use rises levels of cortisol but not of adrenocorticotropic hormone (ACTH)(First week in ICU)
研究者
Javier Pascual-Ramirez
MD
Hospital General de Ciudad Real
研究点 (1)
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