Ignite Creation Date:
2024-05-06 @ 2:51 PM
Last Modification Date:
2024-10-26 @ 1:38 PM
Study NCT ID:
NCT04440085
Status:
UNKNOWN
Last Update Posted:
2020-06-19
First Post:
2020-06-13
Brief Title:
RaGuS Trial by Postoperative Patients
Sponsor:
Bürgerspital Solothurn
Organization:
Bürgerspital Solothurn
Study Overview
Official Title:
RANDOMIZED CASE-CONTROLLED TRIAL ASSESSING MIDODRINE GUTRON IN POSTOPERATIVE VASOPLEGIC PATIENTS
Status:
UNKNOWN
Status Verified Date:
2020-06
Last Known Status:
NOT_YET_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:
RaGuS
Brief Summary:
Vasoplegic syndrome is characterized clinically by reduced systemic vascular resistance and normal or increased cardiac output It is principally observed in cardiovascular and orthopedic interventions and is characterized by a systemic inflammatory response with the inability of the vascular endothelial muscles to contract and a resistance to the action of vasoactive drugs This event extends the length of stay in the critical care area due to the need of vasoactive drugs
The investigators aim to assess the standardized application of midodrine in postoperative patients without sepsis and need of vasoactive drugs in order to reduce the length of stay in critical care area and for extension in hospital
The investigators aim to assess the standardized application of midodrine in postoperative patients without sepsis and need of vasoactive drugs in order to reduce the length of stay in critical care area and for extension in hospital
Detailed Description:
Midodrine is an alpha 1 receptor agonist used usually in cases of hypotension helping to increase blood pressure The main indication is orthostatic hypotension but there are other clinical conditions where this medicament is often used like hypotension by dialysis hepatorenal syndrome and after carotid artery stenting
Vasoplegic syndrome coul be interpreted as a variant of orthostatic hypotension that happens usually after surgical interventions It produces a loss of systemic vascular resistance due to inflammatory reaction without any signs of infection
The investigators aim to conduct a randomized double-blind single-center placebo-controlled study of midodrine in patients who present postoperative vasoplegia with no active signs of sepsis but need of vasoactive drugs Noradrenalin
Vasoplegic syndrome coul be interpreted as a variant of orthostatic hypotension that happens usually after surgical interventions It produces a loss of systemic vascular resistance due to inflammatory reaction without any signs of infection
The investigators aim to conduct a randomized double-blind single-center placebo-controlled study of midodrine in patients who present postoperative vasoplegia with no active signs of sepsis but need of vasoactive drugs Noradrenalin
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