MADAME: Manual Lymphatic Drainage in Patients After Septic Shock

Sponsor

University Hospital Ostrava (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05874895

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Sepsis is a multi-organ dysfunction caused by the dysregulated response of the human body to infection. A key part of this response is an excessive pro-inflammatory response, the recommended treatment interventions in the early stage of sepsis have directly or indirectly anti-inflammatory character. The goal of therapeutic interventions is thus to reduce the intensity of the inflammatory response.

Condition or Disease	Intervention/Treatment	Phase
Sepsis Multiorgan Failure Inflammatory Response Septic Shock	Procedure: Manual Lymphatic Drainage Procedure: Usual Care	N/A

Detailed Description

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 Design

Study Type:

Interventional

Anticipated Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

The study subjects will be randomized in two study arms.The study subjects will be randomized in two study arms.

Masking:

None (Open Label)

Masking Description:

No masking will be used in this study.

Primary Purpose:

Treatment

Official Title:

Manual Lymphatic Drainage in Patients After Septic Shock: A Safety and Feasibility Pilot Randomized Controlled Trial

Anticipated Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

May 31, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Manual Lymphatic Drainage In addition to usual care, daily manual lymphatic drainage will be performed for five consecutive days. After this period.	Procedure: Manual Lymphatic Drainage Manual lymphatic drainage massage involves gently manipulating specific areas of the body to help lymph move to an area with working lymph vessels.
Active Comparator: Usual Care Usual care for patients with septic shock will be provided.	Procedure: Usual Care Usual care provided for patients in septic shock.

Arm

Intervention/Treatment

Experimental: Manual Lymphatic Drainage

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

Procedure: Manual Lymphatic Drainage

Manual lymphatic drainage massage involves gently manipulating specific areas of the body to help lymph move to an area with working lymph vessels.

Active Comparator: Usual Care

Usual care for patients with septic shock will be provided.

Procedure: Usual Care

Usual care provided for patients in septic shock.

Outcome Measures

Primary Outcome Measures

Feasibility Outcome - number of patients undergoing manual lymphatic drainage procedure. [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. [12 months]
It is expected that manual lymphatic drainage procedure will be performed in at least 80 per cent of patients.
Safety Outcome - the percentage of cases when the manual lymphatic drainage procedure interferes with standard nursing care [12 months]
interference is assumed in 0 per cent of cases
Safety Outcome - incidence of the need to restart circulatory support with norepinephrine [12 months]
The presumed incidence is assumed in 0 per cent of cases
Safety Outcome - incidence of thromboembolic events [12 months]
The presumed incidence is assumed in 0 per cent of cases
Efficacy Outcome - change in SOFA (sequential organ failure assessment) score [12 months]
Comparison of the SOFA score on Days 3 and 5 versus Day 0 (randomisation day)
Efficacy Outcome - incidence of delirium [12 months]
Incidence of delirium for the period from randomisation until discharge from ICU
Efficacy Outcome - 28-day mortality [12 months]
28-day mortality will be observed

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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).