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MAnual Lymphatic DrAinage to iMprove the outcomE of Patients After Septic Shock (MADAME)

Primary Purpose

Sepsis, Multiorgan Failure, Inflammatory Response

Status
Recruiting
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Manual Lymphatic Drainage
Usual Care
Sponsored by
University Hospital Ostrava
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sepsis focused on measuring Sepsis, Multiorgan Failure, Excessive Inflammatory Response, Manual Lymphatic Drainage, Lymphatic System, Septic Shock

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 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).

Sites / Locations

  • University Hospital OstravaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Manual Lymphatic Drainage

Usual Care

Arm Description

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

Usual care for patients with septic shock will be provided.

Outcomes

Primary Outcome Measures

Feasibility Outcome - number of patients undergoing manual lymphatic drainage procedure.
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.
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
interference is assumed in 0 per cent of cases
Safety Outcome - incidence of the need to restart circulatory support with norepinephrine
The presumed incidence is assumed in 0 per cent of cases
Safety Outcome - incidence of thromboembolic events
The presumed incidence is assumed in 0 per cent of cases
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)
Efficacy Outcome - incidence of delirium
Incidence of delirium for the period from randomisation until discharge from ICU
Efficacy Outcome - 28-day mortality
28-day mortality will be observed

Secondary Outcome Measures

Full Information

First Posted
May 11, 2023
Last Updated
June 13, 2023
Sponsor
University Hospital Ostrava
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1. Study Identification

Unique Protocol Identification Number
NCT05874895
Brief Title
MAnual Lymphatic DrAinage to iMprove the outcomE of Patients After Septic Shock
Acronym
MADAME
Official Title
MAnual Lymphatic DrAinage to iMprove the outcomE of Patients After Septic Shock: A Safety and Feasibility Pilot Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2023 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Ostrava

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis, Multiorgan Failure, Inflammatory Response, Septic Shock
Keywords
Sepsis, Multiorgan Failure, Excessive Inflammatory Response, Manual Lymphatic Drainage, Lymphatic System, Septic Shock

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study subjects will be randomized in two study arms.
Masking
None (Open Label)
Masking Description
No masking will be used in this study.
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Manual Lymphatic Drainage
Arm Type
Experimental
Arm Description
In addition to usual care, daily manual lymphatic drainage will be performed for five consecutive days. After this period.
Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
Usual care for patients with septic shock will be provided.
Intervention Type
Procedure
Intervention Name(s)
Manual Lymphatic Drainage
Intervention Description
Manual lymphatic drainage massage involves gently manipulating specific areas of the body to help lymph move to an area with working lymph vessels.
Intervention Type
Procedure
Intervention Name(s)
Usual Care
Intervention Description
Usual care provided for patients in septic shock.
Primary Outcome Measure Information:
Title
Feasibility Outcome - number of patients undergoing manual lymphatic drainage procedure.
Description
The anticipated number of patients is 2 per month.
Time Frame
12 months
Title
Feasibility Outcome - The percentage of patients suitable for manual lymphatic drainage procedure in whom this procedure has been performed.
Description
It is expected that manual lymphatic drainage procedure will be performed in at least 80 per cent of patients.
Time Frame
12 months
Title
Safety Outcome - the percentage of cases when the manual lymphatic drainage procedure interferes with standard nursing care
Description
interference is assumed in 0 per cent of cases
Time Frame
12 months
Title
Safety Outcome - incidence of the need to restart circulatory support with norepinephrine
Description
The presumed incidence is assumed in 0 per cent of cases
Time Frame
12 months
Title
Safety Outcome - incidence of thromboembolic events
Description
The presumed incidence is assumed in 0 per cent of cases
Time Frame
12 months
Title
Efficacy Outcome - change in SOFA (sequential organ failure assessment) score
Description
Comparison of the SOFA score on Days 3 and 5 versus Day 0 (randomisation day)
Time Frame
12 months
Title
Efficacy Outcome - incidence of delirium
Description
Incidence of delirium for the period from randomisation until discharge from ICU
Time Frame
12 months
Title
Efficacy Outcome - 28-day mortality
Description
28-day mortality will be observed
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiří Hynčica
Phone
0042059737
Ext
2587
Email
jiri.hyncica@fno.cz
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roman Kula, MD,CSc
Organizational Affiliation
University Hospital Ostrava
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ostrava
City
Ostrava
State/Province
Moravian-Silesian Region
ZIP/Postal Code
708 52
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiří Hynčica
Phone
0042059737
Ext
2587
Email
jiri.hyncica@fno.cz
First Name & Middle Initial & Last Name & Degree
Roman Kula, MD,CSc
First Name & Middle Initial & Last Name & Degree
Ondřej Jor, MD,PhD
First Name & Middle Initial & Last Name & Degree
Hana Straková, MD
First Name & Middle Initial & Last Name & Degree
Jan Štigler, MD,Ing
First Name & Middle Initial & Last Name & Degree
Tatiana Sušková, MD
First Name & Middle Initial & Last Name & Degree
Martina Pavlicová, MD
First Name & Middle Initial & Last Name & Degree
Yvetta Vantuchová, MD,PhD
First Name & Middle Initial & Last Name & Degree
Radana Hromádková, MD
First Name & Middle Initial & Last Name & Degree
Lenka Krupová, Mgr.,PhD.,MBA
First Name & Middle Initial & Last Name & Degree
Renáta Schrebenská
First Name & Middle Initial & Last Name & Degree
Kamila Stájníková

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to make individual participant data available to other researchers.
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MAnual Lymphatic DrAinage to iMprove the outcomE of Patients After Septic Shock

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