Ignite Creation Date:
2024-05-06 @ 10:12 AM
Last Modification Date:
2024-10-26 @ 12:26 PM
Study NCT ID:
NCT03193164
Status:
SUSPENDED
Last Update Posted:
2021-02-05
First Post:
2017-06-05
Brief Title:
Neuromuscular Electrical Stimulation and Septic Shock
Sponsor:
University of Sao Paulo
Organization:
University of Sao Paulo
Study Overview
Official Title:
Effects of Physical Therapy With Neuromuscular Electrical Stimulation in Patients With Septic Shock a Randomised Crossover Clinical Trial Protocol
Status:
SUSPENDED
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
This study had to be suspended due to COVID-19 Pandemic
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study will investigate the effects of neuromuscular electrical stimulation NMES in patients with septic shock The objective of this study will be investigate the effects of neuromuscular electrical stimulation NMES in patients with septic shock
Detailed Description:
The study will investigate the effects of neuromuscular electrical stimulation NMES in patients with septic shock
It will be a randomised crossover clinical trial Thirty-one patients will enrolledThe study will be divided in two phases the first will be held in the first 72 hours of septic shock and the second after three days of first assessment Patients will be selected randomly to the intervention Protocol NMES and control positioning After this procedure the patients will be allocated in Group 1 NMES and control or group 2 control and NMES with a wash-out period of 4 to 6 hours in between
The main outcome will be the study of mobilization of endothelial progenitor cells EPCs The secondary outcome will be the metabolic and hemodynamic data Linear mixed model will be used for analysis of dependent variables and estimated values of the mean of the differences of each effect
The results of this study will allow better understanding of the effects of NMES in patients with septic shock
It will be a randomised crossover clinical trial Thirty-one patients will enrolledThe study will be divided in two phases the first will be held in the first 72 hours of septic shock and the second after three days of first assessment Patients will be selected randomly to the intervention Protocol NMES and control positioning After this procedure the patients will be allocated in Group 1 NMES and control or group 2 control and NMES with a wash-out period of 4 to 6 hours in between
The main outcome will be the study of mobilization of endothelial progenitor cells EPCs The secondary outcome will be the metabolic and hemodynamic data Linear mixed model will be used for analysis of dependent variables and estimated values of the mean of the differences of each effect
The results of this study will allow better understanding of the effects of NMES in patients with septic shock
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?:
None
Is an FDA AA801 Violation?:
None