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临床试验/NCT05080543
NCT05080543Unknown1 期

Recruitment of Microcirculation Using Albumin 20% and Terlipressin in Patients With Septic Shock: a Randomized Controlled Double-blinded Study.

Amany Mousa Salama Muhammed0 个研究点目标入组 36 人开始时间: 2021年10月最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

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

Placebo Comparator

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

发起方
Amany Mousa Salama Muhammed
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Amany Mousa Salama Muhammed

CairoU

Cairo University

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