Therapeutic Plasmaexchange in Early Septic Shock

Septic Shock Clinical Trial

— EXCHANGE  

Official title:

Prospective, Randomized, Single-center, Open-label, Parallel-group Trial Investigating the Efficacy of Therapeutic Plasma Exchange as an Adjunctive Strategy Against Early Septic Shock - Effect on Hemodynamics and Biochemical Markers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04231994
• Other study ID #: EXCHANGE 2786-2015
• Status: Completed
• Phase: Phase 2
• Start date: June 1, 2018
• Est. completion date: August 31, 2020

Study information

• Verified date: February 2021
• Source: Hannover Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Sepsis is defined by the occurrence of critical organ dysfunction in the context of infection. Unfortunately, its incidence appears to be rising, and the mortality of septic shock remains extraordinary high (> 60%). Death in sepsis arises from shock and multi organ dysfunction that are - at least in part - triggered by an inadequate response of the host's immune system to the infection. Given the injurious role of 1) this overwhelming immune response and 2) the consumption of protective plasmatic factors (e.g. vWF cleaving proteases, hemostatic factors etc.) while the disease is progressing the investigators hypothesize that early therapeutic plasma exchange (TPE) in the most severely ill individuals might improve hemodynamics, oxygenation and ultimately survival. This therapeutic strategy combines 2 major aspects in 1 procedure: 1. removal of harmful circulating molecules and 2. replacement of protective plasma proteins. The investigators designed the EXCHANGE trial to analyze in a randomized fashion the benefit of TPE as an add-on treatment to state of the art standard sepsis care. Only patients with early septic shock (< 24 hrs) and high catecholamine doses (norepinephrine > 0.4 ug/kg body weight/min) will be included. Those in the treatment group will receive 1 TPE within 2 hours following randomization. The primary outcome is norepinephrine dose 6 hrs after randomization. The recruitment period is 2 years and will be performed at the Hannover medical School University hospital in Germany. Secondary endpoints (including organ dysfunction as well as biochemical markers of inflammation and coagulation) will be assessed on day 1-8 and day 28 after TPE.

The investigators hope to demonstrate a potential benefit of an additive treatment approach to improve the outcome of patients suffering from septic shock.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 31, 2020
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Onset of septic shock within less than 24 hrs

• Norepinephrine dose of = 0.4 ug/kg/min bodyweight (target mean arterial pressure = 65 mmHg) = 30 min

Exclusion Criteria:

• Age<18 years and > 80 years

• Pregnancy

• Known history of transfusion reactions

Related Conditions & MeSH terms

• Septic Shock
• Shock
• Shock, Septic

Intervention

Device:
• TPE
singular Therapeutic Plasma Exchange using fresh frozen Plasma as replacement fluid

Locations

Country	Name	City	State
Germany	University Hospital Bonn	Bonn
Germany	Hannover Medical School	Hannover	Lower Saxony

Sponsors (1)

Lead Sponsor	Collaborator
Hannover Medical School

Country where clinical trial is conducted

Germany, 

References & Publications (1)

David S, Bode C, Putensen C, Welte T, Stahl K; EXCHANGE study group. Adjuvant therapeutic plasma exchange in septic shock. Intensive Care Med. 2021 Jan 20. doi: 10.1007/s00134-020-06339-1. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Norepinephrine dose	Vasopressor dose reduction as indicator of shock reversal	6 hours after randomization
Secondary	Mean Sequential organ failure assessment (SOFA) score	SOFA score as indicator of organ dysfunction	day 1-8 following randomization
Secondary	percent change of ADAMTS-13 activity from baseline	(will only be analyzed in the Hannover cohort)	6 hours after randomization
Secondary	percent change of activated Protein C activity from baseline	(will only be analyzed in the Hannover cohort)	6 hours after randomization
Secondary	percent change of permeability factors angiopoietin-1, -2 and sTie-2 from baseline	permeability and anti-permeability factors (will only be analyzed in the Hannover cohort)	6 hours after randomization
Secondary	28 day survival		after 28 days following randomization

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