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临床试验/NCT05874895
NCT05874895已完成不适用

MAnual Lymphatic DrAinage to iMprove the outcomE of Patients After Septic Shock: A Safety and Feasibility Pilot Randomized Controlled Trial

University Hospital Ostrava1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2023年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
24
试验地点
1
主要终点
Safety Outcome - incidence of thromboembolic events

研究概览

简要总结

Antimicrobial and supportive therapeutic interventions in patients with septic shock are usually effective - procalcitonin and interleukin-6 levels fall rapidly in most cases, and noradrenaline support can be discontinued within a few days. Unfortunately, only in a small portion of patients, do the organ functions improve at the same time, and in most of them, multi-organ failure persists. Therefore, it is likely that, in addition to infection and the response to infection, other mechanisms are also involved in the persistence of organ failure in patients after septic shock.

详细描述

One of the possible explanations for prolonged multi-organ dysfunction after an excessive inflammatory phase is a disorder of "post-inflammatory cleaning", the so-called resolution of inflammation. The resolution of inflammation is a regulated process in which the controlling action of specialized pro-resolution mediators (lipoxins, resolvins, etc.), conversion of pro-inflammatory macrophages (M1) to pro-resolution (M2., induce the process of structural tissue restoration), autophagy plays a significant role and, of course, the flushing of accumulated interstitial fluid with waste products by lymphatic drainage. Any disturbance in pro-resolution mechanisms can lead to prolonged organ dysfunction.

The lymphatic system plays a key role in maintaining fluid homeostasis. Its ability to drain interstitial fluid can increase up to 20 times. However, even such an increase may not be sufficient in the situation of extreme interstitial fluid sequestration that accompanies septic shock. In addition, some inflammatory mediators (for example, nitric oxide, TNF-α, Interleukin-1β) cause relaxation of the vascular structures of the lymphatic system, slowing the flow of lymph. The result is the persistence of tissue swelling with tissue hypoxia due to the extension of the diffusion path for oxygen and the accumulation of waste products of inflammation.

Manual lymphatic drainage (MLD) is one of the treatments that stimulate the lymphatic system. In general, it is expected to accelerate the outflow of lymph and waste products from tissues previously affected by inflammation, accelerate the recovery of tissue function, sympatholytic effect and increase the tension of the vagus nerve. It can therefore be assumed that MLD will have a beneficial effect on the course of persistent multi-organ dysfunction in patients after therapeutically managed septic shock.

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
None

盲法说明

No masking will be used in this study.

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

  • •diagnosis of septic shock at admission to ICU
  • •sepsis or suspicion of sepsis
  • •noradrenaline support required in order to maintain mean arterial pressure ≥ 65 mmHg
  • •serum lactate ≥ 2 mmol/L

排除标准

  • •patients <18 years of age
  • •pregnant women with septic shock, in whom the pregnancy has been preserved
  • •patients with a history of heart failure with NYHA (New York Heart Association) classification ≥ III
  • •patients with a history of thromboembolic events
  • •patients with septic shock transferred from another department/hospital, if the length of stay at the previous workplace exceeded 72 hours
  • •patients with septic shock and an inauspicious prognosis, or in the phase of withdrawal of treatment
  • •patients with uncontrolled infection
  • •patients with septic shock who lack informed consent
  • •patients with septic shock, in whom the SOFA score decreased by more than 50% during the day following the withdrawal of noradrenaline (i.e. a subgroup of patients with a rapid improvement of the clinical course after the resolution of septic shock).

研究组 & 干预措施

Manual Lymphatic Drainage

Experimental

In addition to usual care, daily manual lymphatic drainage will be performed for five consecutive days. After this period.

干预措施: Manual Lymphatic Drainage (Procedure)

Usual Care

Active Comparator

Usual care for patients with septic shock will be provided.

干预措施: Usual Care (Procedure)

结局指标

主要结局

Safety Outcome - incidence of thromboembolic events

时间窗: 12 months

The presumed incidence is assumed in 0 per cent of cases

Safety Outcome - the percentage of cases when the manual lymphatic drainage procedure interferes with standard nursing care

时间窗: 12 months

interference is assumed in 0 per cent of cases

Efficacy Outcome - change in SOFA (sequential organ failure assessment) score

时间窗: 12 months

Comparison of the SOFA score on Days 3 and 5 versus Day 0 (randomisation day)

Feasibility Outcome - number of patients undergoing manual lymphatic drainage procedure.

时间窗: 12 months

The anticipated number of patients is 2 per month.

Feasibility Outcome - The percentage of patients suitable for manual lymphatic drainage procedure in whom this procedure has been performed.

时间窗: 12 months

It is expected that manual lymphatic drainage procedure will be performed in at least 80 per cent of patients.

Efficacy Outcome - 28-day mortality

时间窗: 12 months

28-day mortality will be observed

Safety Outcome - incidence of the need to restart circulatory support with norepinephrine

时间窗: 12 months

The presumed incidence is assumed in 0 per cent of cases

Efficacy Outcome - incidence of delirium

时间窗: 12 months

Incidence of delirium for the period from randomisation until discharge from ICU

次要结局

未报告次要终点

研究者

发起方
University Hospital Ostrava
申办方类型
Other
责任方
Sponsor

研究点 (1)

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