Ignite Creation Date:
2024-05-05 @ 4:37 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00273728
Status:
COMPLETED
Last Update Posted:
2011-08-12
First Post:
2006-01-06
Brief Title:
BaSES Trial Basel Starch Evaluation in Sepsis
Sponsor:
University Hospital Basel Switzerland
Organization:
University Hospital Basel Switzerland
Study Overview
Official Title:
Basel Study for Evaluation of Starch 13004 Infusion in Septic Patients BaSES 13004 Trial
Status:
COMPLETED
Status Verified Date:
2011-08
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:
BaSES
Brief Summary:
Background In patients with severe sepsis and septic shock early aggressive volume replacement reduced mortality Standard infusion therapy consists of crystalloid infusions The role of modern low molecular weight starch preparations and their influence on the course of disease is not determined yet
Hypothesis The purpose of this study is to determine wether initial infusion therapy with Hydroxyethylstarch and Ringers lactate reduces in septic patients reduces Intensive Care Unit and hospital length of stay without impairment of renal function
Design Double-blind randomized controlled monocentric study
Setting Intensive Care Units of a University Hospital
Patients 240 consecutive patients with sepsis severe sepsis and septic shock
Intervention Volume therapy with Ringers lactate and saline or hydroxy-ethyl starch MW 130 substitution 04 in the first five days of intensive care treatment
Parameter
Intensive Care length of stay
Hospital length of stay
Mortality
Kidney function
Statistics Mann-Whitney test for non-parametric data like intensive care length of stay Unpaired t-Test for kidney function parameters
Study withdrawal Significant impairment of kidney function parameters in the hydroxy-ethyl starch group
Hypothesis The purpose of this study is to determine wether initial infusion therapy with Hydroxyethylstarch and Ringers lactate reduces in septic patients reduces Intensive Care Unit and hospital length of stay without impairment of renal function
Design Double-blind randomized controlled monocentric study
Setting Intensive Care Units of a University Hospital
Patients 240 consecutive patients with sepsis severe sepsis and septic shock
Intervention Volume therapy with Ringers lactate and saline or hydroxy-ethyl starch MW 130 substitution 04 in the first five days of intensive care treatment
Parameter
Intensive Care length of stay
Hospital length of stay
Mortality
Kidney function
Statistics Mann-Whitney test for non-parametric data like intensive care length of stay Unpaired t-Test for kidney function parameters
Study withdrawal Significant impairment of kidney function parameters in the hydroxy-ethyl starch group
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 |
|---|---|---|---|
| EKBB EK 24404 | None | None | None |