Ignite Creation Date:
2024-05-05 @ 4:36 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00271752
Status:
COMPLETED
Last Update Posted:
2010-03-04
First Post:
2006-01-01
Brief Title:
The Procalcitonin and Survival Study
Sponsor:
Danish Procalcitonin Study Group
Organization:
Danish Procalcitonin Study Group
Study Overview
Official Title:
The Procalcitonin and Survival Study - A Multicentre Single Blinded Randomized Controlled Trial to Investigate if Treatment Guided by Daily Procalcitonin Measurements Can Reduce Mortality in the Intensive Care Unit
Status:
COMPLETED
Status Verified Date:
2010-03
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:
PASS
Brief Summary:
This is a randomised single blinded multicentre trial to evaluate whether daily procalcitonin PCT measurements and immediate diagnostic and therapeutic responses to abnormal values and day-to-day changes can reduce the mortality of critically ill patients in the Intensive Care Unit ICU
Detailed Description:
Sepsis and complications to sepsis are major causes of mortality in critically ill patients Rapid treatment of sepsis is of crucial importance for survival of patients In the ICU the infectious status of the patient is often difficult to assess because symptoms cannot be expressed unconscious or sedated patients and signs may present atypically because of immunologic incompetence and masking by the drugs given and thermo-therapy Biological and biochemical markers of inflammation White Blood Cells WBC C-reactive protein may often be influenced by other parameters than infection such as trauma surgery other types of inflammation such as rheumatoid diseases C-reactive protein and gluco-corticosteroid treatment WBC and may be unacceptably slowly released after progression of an infection At the same time lack of a relevant antimicrobial therapy in an early course of infection may be fatal for the patient
For these reasons in the clinical setting it is often necessary to initiate or adjust antimicrobial therapy on an unsure ground and the relevant therapy may in some situations be delayed for important hours or even days Specific and rapid markers of bacterial infection have been sought for use in the ICU Mortality in critically ill patients increases gravely when Procalcitonin levels increase from day to day own submitted though yet unpublished data Low PCT levels have been shown to effectively rule out sepsis
However no randomised controlled trials have been conducted to show if mortality in critically ill patients can be reduced by using a strategy of daily standardised Procalcitonin measurements as an early detector of serious bacterial infection Therefore evidence is presently not sufficient to introduce daily consecutive Procalcitonin measurements to guide the diagnostic and therapeutic management of patients admitted to the ICU
The rationale for this trial is to assess the ability of daily Procalcitonin measurements to reduce the mortality of critically ill patients
For these reasons in the clinical setting it is often necessary to initiate or adjust antimicrobial therapy on an unsure ground and the relevant therapy may in some situations be delayed for important hours or even days Specific and rapid markers of bacterial infection have been sought for use in the ICU Mortality in critically ill patients increases gravely when Procalcitonin levels increase from day to day own submitted though yet unpublished data Low PCT levels have been shown to effectively rule out sepsis
However no randomised controlled trials have been conducted to show if mortality in critically ill patients can be reduced by using a strategy of daily standardised Procalcitonin measurements as an early detector of serious bacterial infection Therefore evidence is presently not sufficient to introduce daily consecutive Procalcitonin measurements to guide the diagnostic and therapeutic management of patients admitted to the ICU
The rationale for this trial is to assess the ability of daily Procalcitonin measurements to reduce the mortality of critically ill patients
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