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临床试验/NCT06122909
NCT06122909已完成3 期

The Effect Of Resuscitation Guided By Two Different Dynamic Parameters On Time To Normalization Of The Capillary Refill Time In Adult Patients With Septic Shock, A Randomized Controlled Prospective Study

Kasr El Aini Hospital2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2023年7月21日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
90
试验地点
2
主要终点
Time to normalization of the capillary refill time (≤ 3 sec)

研究概览

简要总结

The aim of this study is to compare the effect of resuscitation guided by Left ventricular outflow tract-velocity time integral (LVOT-VTI) variation versus the effect of resuscitation guided by inferior vena cava (IVC) variation on time to normalization of the capillary refill time in adult patients with septic shock, amount of resuscitation fluids, rate of vasopressor and ICU length of stay.

详细描述

Capillary refill time will be measured by applying firm pressure to the ventral surface of the right index finger distal phalanx with a glass microscope slide. The pressure will be increased until the skin is blank and then maintained for 10 seconds. The time for return of the normal skin color will be registered with a chronometer. A CRT > 3 seconds will be considered abnormal.

Patients with normal CRT at baseline will proceed to periodic monitoring (every hour/6 hours) and start the algorithm if CRT becomes abnormal at any of these timepoints. Patients with abnormal CRT will follow the loop when fulfilling the Sepsis-3 definition of septic shock.

Sepsis time 0 is defined as the time of admission to the ICU for sepsis treatment upon the inclusion criteria. For patients already in the ICU, sepsis time 0 is considered the earliest time at which the patients satisfy the inclusion criteria.

Fluid responsiveness FR will be assessed using a structured approach. Dynamic predictors of FR will be evaluated depending on the individual status, i.e., considering if under MV or spontaneous breathing, Vt, respiratory rate (RR), respiratory system compliance and the presence of arrhythmias.

Passive leg raise PLR is performed by tilting a patient from a 45-degree semi-recumbent head-up position to a 30-45° degree leg-up position or by lifting the legs passively from the horizontal position. This maneuver transfers up to 300 mL of blood from the lower limbs and the splanchnic territory into the intrathoracic compartment and induces significant changes in cardiac preload, mean systemic pressure and the upstream pressure of systemic venous return. It is reliable and can be implemented in either spontaneously breathing or mechanically ventilated patients and can often be repeated. A method that has been recommended by the Surviving Sepsis Campaign, and is appraised by the European Society of Intensive Care Medicine.

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
Double (Participant, Outcomes Assessor)

盲法说明

Both participants and outcome assessors will be blinded to the groups

入排标准

年龄范围
19 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •adult patients ( ≥ 18 years) of either gender with septic shock according to the Sepsis-3

排除标准

  • •Known history of any cardiac pathology, acute coronary syndrome, cardiac dysrhythmias (as a primary diagnosis), acute pulmonary edema or known poor systolic cardiac function (left ventricular ejection fraction < 50%).
  • •Body mass index ≥ 35 kg/m2 .
  • •Concomitant acute respiratory distress syndrome) or high PEEP (> 10 cmH2O) requirements on mechanical ventilation (MV).
  • •Child B or C liver cirrhosis.
  • •End-stage renal disease with or without dialysis.
  • •Pregnancy.
  • •Multi-organ system failure.
  • •Active hemorrhage.
  • •Head trauma.
  • •Intra-abdominal hypertension (> 15 mmHg).
  • •Declined to consent.

研究组 & 干预措施

Group IVC

Active Comparator

Group IVC (n=45): will receive resuscitation guided by IVC diameter variation after PLR test.

干预措施: Group IVC (Drug)

Group VTI

Experimental

Group VTI (n=45): will receive resuscitation guided by LVOT-VTI variation after PLR test.

干预措施: Group VTI (Drug)

结局指标

主要结局

Time to normalization of the capillary refill time (≤ 3 sec)

时间窗: 12 hours

Time to normalization of the capillary refill time (≤ 3 sec.) in adult patients with septic shock at 6h of septic shock recognition in patients with delayed capillary refill time (\> 3 sec.)

次要结局

  • Change in Creatinine-based Kidney Disease: Improving Global Outcome (KDIGO) score(72 hours)
  • Total amount of vasopressors.(24 hours)
  • ICU length of stay(1 week)
  • Amount of resuscitation fluids(24 hours)

研究者

发起方
Kasr El Aini Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Khaled Abdelfattah Abdallah Sarhan

principal investigator, Asst. professor of anesthesia, Cairo university

Kasr El Aini Hospital

研究点 (2)

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