Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00135473
Status:
COMPLETED
Last Update Posted:
2016-02-11
First Post:
2005-08-24
Brief Title:
Efficacy of Volume Substitution and Insulin Therapy in Severe Sepsis VISEP Trial
Sponsor:
SepNet - Critical Care Trials Group
Organization:
SepNet - Critical Care Trials Group
Study Overview
Official Title:
Prospective Randomized Multicenter Study on the Influence of Colloid vs Crystalloid Volume Resuscitation and of Intensive vs Conventional Insulin Therapy on Outcome in Patients With Severe Sepsis and Septic Shock
Status:
COMPLETED
Status Verified Date:
2016-02
Last Known Status:
None
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:
None
Brief Summary:
The purpose of this trial is to determine the influence of colloid versus crystalloid volume resuscitation and of intensive vs conventional insulin therapy on morbidity and mortality of patients with severe sepsis and septic shock
Detailed Description:
Severe sepsis and septic shock have a high mortality Research has concentrated on adjunctive sepsis therapies the role of supportive measures is comparatively unclear In Europe the use of colloids is widespread but there is no evidence on the role of either crystalloid or colloid volume therapy in sepsis Recently a higher incidence of kidney failure in sepsis was reported after administration of colloids
In critical illness a significant reduction in mortality was recently achieved by strict glycemic control however it has to be determined whether this is true and safe for patients with sepsis as well
In critical illness a significant reduction in mortality was recently achieved by strict glycemic control however it has to be determined whether this is true and safe for patients with sepsis as well
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 |
|---|---|---|---|
| 01 KI 0106 BMBF | None | None | None |