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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Manual lymphatic drainage massage involves gently manipulating specific areas of the body to help lymph move to an area with working lymph vessels.
Usual care provided for patients in septic shock.
University Hospital Ostrava
Ostrava, Moravian-Silesian Region, Czechia
Feasibility Outcome - number of patients undergoing manual lymphatic drainage procedure.
The anticipated number of patients is 2 per month.
Time frame: 12 months
Feasibility Outcome - The percentage of patients suitable for manual lymphatic drainage procedure in whom this procedure has been performed.
It is expected that manual lymphatic drainage procedure will be performed in at least 80 per cent of patients.
Time frame: 12 months
Safety Outcome - the percentage of cases when the manual lymphatic drainage procedure interferes with standard nursing care
interference is assumed in 0 per cent of cases
Time frame: 12 months
Safety Outcome - incidence of the need to restart circulatory support with norepinephrine
The presumed incidence is assumed in 0 per cent of cases
Time frame: 12 months
Safety Outcome - incidence of thromboembolic events
The presumed incidence is assumed in 0 per cent of cases
Time frame: 12 months
Efficacy Outcome - change in SOFA (sequential organ failure assessment) score
Comparison of the SOFA score on Days 3 and 5 versus Day 0 (randomisation day)
Time frame: 12 months
Efficacy Outcome - incidence of delirium
Incidence of delirium for the period from randomisation until discharge from ICU
Time frame: 12 months
Efficacy Outcome - 28-day mortality
28-day mortality will be observed
Time frame: 12 months
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