Manual lymphatic drainage to improve outcomes after septic shock
MAnual Lymphatic DrAinage to iMprove the outcomE of Patients After Septic Shock: A Safety and Feasibility Pilot Randomized Controlled Trial
This study tests if manual lymphatic drainage can help patients recovering from septic shock feel better and improve their organ function compared to standard care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital Ostrava Academic / other |
| Locations | 1 site (Ostrava, Moravian-Silesian Region) |
| Trial ID | NCT05874895 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of manual lymphatic drainage (MLD) on patients diagnosed with septic shock. It aims to address the prolonged multi-organ dysfunction that can occur after septic shock by enhancing the lymphatic system's ability to clear interstitial fluid and inflammatory mediators. Patients receiving MLD will be compared to those receiving usual care to evaluate improvements in organ function and overall recovery. The study focuses on understanding the role of inflammation resolution and lymphatic drainage in recovery from septic shock.
Who should consider this trial
Good fit: Ideal candidates for this study are adults diagnosed with septic shock requiring noradrenaline support to maintain blood pressure.
Not a fit: Patients under 18 years old, pregnant women, or those with severe comorbidities such as advanced heart failure or uncontrolled infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve recovery outcomes for patients suffering from septic shock and reduce the duration of multi-organ failure.
How similar studies have performed: While the specific application of manual lymphatic drainage in septic shock is novel, similar approaches targeting inflammation resolution have shown promise in other contexts.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Ostrava, Moravian-Silesian Region
- University Hospital Ostrava — Ostrava, Moravian-Silesian Region, Czechia (Recruiting)
Study contacts
- Principal investigator: Roman Kula, MD,CSc — University Hospital Ostrava
- Study coordinator: Jiří Hynčica
- Email: jiri.hyncica@fno.cz
- Phone: 0042059737
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.