Ignite Creation Date:
2024-05-05 @ 11:10 PM
Last Modification Date:
2024-10-26 @ 10:29 AM
Study NCT ID:
NCT01271114
Status:
TERMINATED
Last Update Posted:
2014-03-10
First Post:
2011-01-04
Brief Title:
Hypertonic Saline and Terlipressin for Sepsis-associated Hypotension
Sponsor:
Hospital General de Ciudad Real
Organization:
Hospital General de Ciudad Real
Study Overview
Official Title:
Hypertonic Saline and Terlipressin Linked To an Early Goal-Driven Protocol for Septic Shock or Sepsis-Associated Hypotension A Pilot Trial HYSATESS
Status:
TERMINATED
Status Verified Date:
2014-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Low recruitment rate
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HYSATESS-p
Brief Summary:
In hypotensive septic patients with controlled source an hemodynamic management protocol including hypertonic saline HSand terlipressin improves MOD Multiple Organ Dysfunction Score by at least 3 points compared to the use of physiologic saline and norepinephrine
The appropriate design for this trial would be factorial For the time being will consider de intervention as a whole unit for this pilot study In the future an appropriately sized factorial multicentric study shall be necessary
Other goals of the pilot study
1 HS restores preload parameters adequately
2 HS associated with terlipressin normalizes blood pressure in septic shock
3 HS associated with terlipressin maintains plasma sodium levels 130-155mEqL
4 There is an inverse relationship between plasma sodium and procalcitonin levels
5 HS increases plasma levels of vasopressin AVP
6 HS rises levels of cortisol but not of adrenocorticotropic hormone ACTH
The appropriate design for this trial would be factorial For the time being will consider de intervention as a whole unit for this pilot study In the future an appropriately sized factorial multicentric study shall be necessary
Other goals of the pilot study
1 HS restores preload parameters adequately
2 HS associated with terlipressin normalizes blood pressure in septic shock
3 HS associated with terlipressin maintains plasma sodium levels 130-155mEqL
4 There is an inverse relationship between plasma sodium and procalcitonin levels
5 HS increases plasma levels of vasopressin AVP
6 HS rises levels of cortisol but not of adrenocorticotropic hormone ACTH
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2010-024138-43 | EUDRACT_NUMBER | None | None |