Comparison of Between Norepinephrine Alone Versus Norepinephrine / Vasopressin Combination for Resuscitation in Septic Shock
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Scvo2
研究概览
简要总结
Although norepinephrine is commonly used and is the recommended agent for the treatment of hypotension in volume-resuscitated hyperdynamic septic shock, Low doses of vasopressin may be added to norepinephrine to maintain arterial blood pressure in refractory septic shock and to decrease exposure to norepinephrine. The aim of the work is to compare the effect of norepinephrine alone and Norepinephrine/vasopressin combination on hemodynamics and tissue perfusion in septic shock patients.
详细描述
Study which was performed on 90 adult of either sex in intensive care unit who developed septic shock.45 patients in each group according to the drugs used, by the single blind technique as the treating physician only is aware of the drugs used.
Group 1: patients received IV Norepinephrine infusion starting with (0.1mcg/kg/min).
Group 2: patients received IV Norepinephrine infusion (Starting with (0.1 mcg/kg/min). +Vasopressin infusion at the rate of (0.03 unit/min).
A comparison was done between both groups as regard:Hemodynamics,Tissue perfusion, C-Reactive Protein (mg/L) ,WBC, UREA (mg/dL),CREATININE (mg/dl), NGAL (Neutrophil gelatinase associated Lipocalin) (ng/ml). Comparison was done at baseline, then every 6 hours for 48 h as regard hemodynamics and tissue perfusion, and at base line then, 24 h and 48 h as regard sepsis biomarkers and renal biomarkers.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years of both sex
- •Exclusion Criteria
- •Patients with renal impairment (Creatinine>2mg/dl)
- •Sever Heart Disease (ischemic/valvular)
- •Peripheral vascular disease (e.g. Raynaud's phenomenon)
排除标准
- 未提供
研究组 & 干预措施
NE
patients received IV Norepinephrine infusion starting with (0.1mcg/kg/min)
干预措施: norepinephrine / Vasopressin (Drug)
NE/VP
patients received IV Norepinephrine infusion (Starting with (0.1 mcg/kg/min). +Vasopressin infusion at the rate of (0.03 unit/min)
干预措施: norepinephrine / Vasopressin (Drug)
结局指标
主要结局
Scvo2
时间窗: 48 hours
Lactate Level Lactate level • (central venous oxygen saturation)SVO2
时间窗: 48 hours
mmol/L
次要结局
- Mortality(28 days)
- CRP(48 hours)
- NGAL, NGAL NGAL(48 hours)
研究者
Hanaa Mohamed Abdallah ElGendy MD
Assistant Professor
Ain Shams University