Recruitment of Microcirculation Using Albumin 20% and Terlipressin in Patients With Septic Shock: a Randomized Controlled Double-blinded Study.
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 36
- 主要终点
- Mean Flow Index 6hs
研究概览
简要总结
The aim of this study is to evaluate the effect of combining HSA 20% and terlipressin on the microcirculation in patients with septic shock using the following;-
- Microcirculation recruitment by Cytocam-IDF.
- Cardiac output by LiDCOrapid.
- Measuring serum lactate level.
详细描述
Sepsis is one of the major medical problems and is responsible for high morbidity and mortality. Surviving Sepsis Campaign Guideline 2016 introduced 3-hours and 6-hours bundles in management of septic shock. The 2018 update of the Surviving Sepsis Campaign guidelines introduced the 'Hour-1 Bundle' which recommends treatment with intravenous fluids, measurement of serum lactate concentration as a marker of illness severity, administration of vasopressors, obtaining blood cultures and administering broad-spectrum antibiotics, all within the first hour.
The usual targets for resuscitation of patients with septic shock are the macro-circulatory parameters such as mean arterial blood pressure and heart rate; however, it is believed that restoration of microcirculatory parameters is not sufficient to avoid organ failure unless it was associated with improved microcirculatory perfusion. The loss of coherence between macro- and micro-circulatory parameters increases the need to evaluate the microcirculatory blood flow. So impaired microvascular perfusion is increasingly recognized as a major determinant of tissue hypoxia during sepsis and is a key factor in the pathogenesis of sepsis-induced organ failure.
Fluid resuscitation is recommended to be initiated immediately and completed within the first hour. Guidelines recommend at least a 30-mL/kg bolus of crystalloid fluid as the initial resuscitation. Crystalloid is the fluid of choice for initial resuscitation and subsequent intra-vascular volume replacement in patients with sepsis and septic shock.
Albumin in addition to crystalloids is suggested when patients require a substantial amount of crystalloids. Although the guidelines make no recommendation regarding which concentration of albumin should be used, 5% albumin is most commonly used in patients with hypovolemia to administer as much volume as possible.
In 2016, a study showed that in a rat model of normotensive endotoxemia, the infusion of 4% or 20% Human Serum Albumin "HSA" restored microvascular perfusion in otherwise unresuscitated animals. A more stable microvascular improvement noticed with 20% HSA.
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 (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
- 否
入选标准
- •The presence of septic shock meeting all of the following criteria less than 24 hours:-
- •Clinically possible or probable or microbiologically confirmed infection taking into account the definitions of the "International Sepsis Forum (ISF)"
- •Despite adequate volume therapy, vasopressors are required to maintain mean arterial pressure (MAP) ≥ 65 mm Hg.
- •Serum lactate level > 2 mmol/l (18 mg/dl) despite adequate volume therapy.
排除标准
- •Patients who failed to achieve target MAP despite adequate resuscitation with fluids and maximum dose of noreadrenaline.
- •Acute coronary artery disease or underlying cardiac dysfunction [cardiac index (CI) <2.2 l/min/m 2 ].
- •Severe liver disease (Child-Pugh grade C)
- •Chronic renal failure.
- •Known hypersensitivity to Norepinephrine, terlipressin and human albumin.
- •Those having Raynaud's phenomenon, or a vasospastic diathesis and
- •Other causes of shock e.g.; hemorrhagic hypovolaemia, cardiogenic shock, anaphylactic shock, neurogenic shock.
- •Pregnant patients and lactation.
研究组 & 干预措施
Group AT
will receive a bolus of albumin (1gm/kg) and terlipressin loading dose of 1 mg over 20 minutes followed by infusion at rate (2 μ g/kg/h)
干预措施: Albumin 20% and terlipressin (Drug)
Controlled
will receive the routine management of septic shock patients as culture-based IV antibiotics, IV fluids and intropic support plus a placebo (as lactated ringer solution in the same infusion rates for blinding).
干预措施: Albumin 20% and terlipressin (Drug)
结局指标
主要结局
Mean Flow Index 6hs
时间窗: 6 hrs
Determination the degree the mean flow index (MFI) 6 hrs after administration albumin and terlipressin in patient with septic shock
次要结局
- Mean Flow Index 24hs(24 hs)
研究者
Amany Mousa Salama Muhammed
CairoU
Cairo University
