Ignite Creation Date:
2024-05-06 @ 9:46 AM
Last Modification Date:
2024-10-26 @ 12:19 PM
Study NCT ID:
NCT03065751
Status:
UNKNOWN
Last Update Posted:
2019-08-08
First Post:
2017-02-23
Brief Title:
Plasmaexchange in Early Septic Shock
Sponsor:
Hannover Medical School
Organization:
Hannover Medical School
Study Overview
Official Title:
Prospective Randomized Multicenter Open-label Controlled Parallel-group Trial Investigating the Efficacy of add-on Plasma-exchange as an Adjunctive Strategy Against Septic Shock
Status:
UNKNOWN
Status Verified Date:
2019-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EXCHANGE
Brief Summary:
Sepsis is defined by the occurrence of a systemic inflammatory response syndrome SIRS 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 hosts immune system to the infection Given the injurious role of 1 this overwhelming immune response and 2 the consumption of protective plasmatic factors eg 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 12 hrs and high catecholamine doses noradrenaline 04 ugkg bodyweightmin will be included Those in the treatment group will receive 3 TPEs within three consecutive days The primary outcome is 28-day all cause mortality To show an assumed reduction from 60 to 45 in the experimental group a sample size of 173 patients per group has been calculated The overall sample size is therefore n346 The recruitment period is 3 years 3 months observation and will be performed in 11 national centers in Germany Secondary endpoints including hemodynamics oxygenation coagulation and microcirculation will be assessed on day 1 2 3 before and after TPE and on day 4 5 7 and 14
Project management and data monitoring will be organized by the Hanover Clinical Trial Center and biostatistics including a web-based randomization will be performed by the Institute of biometrics Prof Koch at Hannover Medical School
The investigators hope to demonstrate a potential benefit of an additive treatment approach to improve the outcome of patients suffering from an under-recognized but deadly disease
Project management and data monitoring will be organized by the Hanover Clinical Trial Center and biostatistics including a web-based randomization will be performed by the Institute of biometrics Prof Koch at Hannover Medical School
The investigators hope to demonstrate a potential benefit of an additive treatment approach to improve the outcome of patients suffering from an under-recognized but deadly disease
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None