Text Size

The Procalcitonin and Survival Study (PASS)

This study has been completed.
Sponsor:
Collaborators:
Copenhagen HIV Programme (CHIP) (GCP-Sponsor)
Danish Research Agency
Hvidovre University Hospital
Information provided by:
Danish Procalcitonin Study Group
ClinicalTrials.gov Identifier:
NCT00271752
First received: January 1, 2006
Last updated: March 3, 2010
Last verified: March 2010
History of Changes
  Purpose

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).


Condition Intervention
Localized Infection
Sepsis
Multiple Organ Failure
 Procedure: Earlier therapeutic changes regarding infection

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Sepsis
U.S. FDA Resources

Further study details as provided by Danish Procalcitonin Study Group:

Primary Outcome Measures:
  • mortality/survival [ Time Frame: 28 day ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • mortality/survival [ Time Frame: 60 day ] [ Designated as safety issue: Yes ]
  • mortality/survival [ Time Frame: 90 day ] [ Designated as safety issue: Yes ]
  • mortality/survival [ Time Frame: 120 day ] [ Designated as safety issue: Yes ]
  • mortality/survival [ Time Frame: 180 day ] [ Designated as safety issue: Yes ]
  • Consumption of antimicrobial chemotherapy [ Time Frame: 28 day ] [ Designated as safety issue: No ]
  • Prevalence of complications to infection: sepsis [ Time Frame: 28 day ] [ Designated as safety issue: Yes ]
  • severe sepsis [ Time Frame: 28 day ] [ Designated as safety issue: Yes ]
  • septic shock [ Time Frame: 28 day ] [ Designated as safety issue: Yes ]
  • Multi Organ Dysfunction Syndrome [ Time Frame: 28 day ] [ Designated as safety issue: Yes ]
  • Disseminated Intravascular Coagulation [ Time Frame: 28 day ] [ Designated as safety issue: Yes ]
  • use of diagnostic imaging during admission to the ICU [ Time Frame: 28 day ] [ Designated as safety issue: No ]
  • Quality of life post-ICU [ Time Frame: 180 day ] [ Designated as safety issue: No ]

Enrollment: 1200
Study Start Date: January 2006
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PCT guided
Procalcitonin guided treatment of infections in the ICU. Intervention: Intensification of antibiotics, surgery, microbiologic testing and diagnostic imaging, when Procalcitonin levels are increasing
 Procedure: Earlier therapeutic changes regarding infection
For every day Procalcitonin levels increase in the intervention group, antibiotics, surgery, diagnostic imaging and microbiologic testing is intensified
Sham Comparator: Control
These patients receive "Standard of Care" which is the recommended treatment in the given ICU
 Procedure: Earlier therapeutic changes regarding infection
For every day Procalcitonin levels increase in the intervention group, antibiotics, surgery, diagnostic imaging and microbiologic testing is intensified

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Fulfilment of all of the following three criteria:

  1. Male or female, aged > 18 years of age.
  2. Admitted to the participating Intensive Care Units (ICUs) at the following hospitals: Hvidovre Hospital, Bispebjerg Hospital, Amager Hospital, Herlev Hospital, Glostrup Hospital, and Gentofte Hospital
  3. Ability to understand and provide written informed consent to participate in this trial; or ability to understand and provide oral informed consent in the presence of at least one impartial witness who should sign and personally date the consent form; or the subject's legally acceptable representative can understand and provide written informed consent if the subject is not capable of this because of the present mental or physical condition of the subject.

Exclusion Criteria:

A subject will NOT be eligible for inclusion in this trial if any of the following criteria apply:

  1. Subjects with known hyperbilirubinaemia (> 0.4 mg/ml) or hypertriglyceridaemia (> 10 g/l) since this can interfere with measurements. If subjects with unknown status on these points are included and have PCT measurements, the measuring equipment will detect these conditions.
  2. Subjects suffering from a blood disorder, where daily sampling of 7 ml of blood for a maximum of 28 days (210 ml distributed on 28 days) will be an inconvenience or a potential risk, which could compromise the safety of the subject.
  3. Subjects who are pregnant or breast feeding

The a priori probability of surviving with the normal recommended diagnostics and treatment with the presently available means to detect infections and, on the other hand, the normal diagnostics and treatment together with daily procalcitonin measurements and prompt clinical reaction should be equal.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00271752

Locations
Denmark
Intensive Care Unit, Bispebjerg Hospital
Copenhagen NV, Copenhagen, Denmark, DK-2400
Intensive Care Unit, KAS Gentofte
Gentofte, Copenhagen, Denmark, DK-2820
Intensive Care Unit, KAS Glostrup, Copenhagen University Hospital
Glostrup, Copenhagen, Denmark, DK-2600
Intensive Care Unit, Herlev Hospital
Herlev, Copenhagen, Denmark, DK-2730
Intensive Care Unit 542, Hvidovre Hospital, Copenhagen University Hospital
Hvidovre, Copenhagen, Denmark, DK-2650
Intensive Care Unit, Hilleroed Sygehus
Hilleroed, Frederiksborg County, Denmark, DK-3400
Skejby Sygehus
Skejby, Århus, Midtjylland, Denmark, DK-8200
Intensive Care Unit, Århus Sygehus, Nørrebrogade
Århus, Midtjylland, Denmark, DK-8000
Roskilde Sygehus
Roskilde, Sjælland, Denmark, DK-4000
Sponsors and Collaborators
Danish Procalcitonin Study Group
Copenhagen HIV Programme (CHIP) (GCP-Sponsor)
Danish Research Agency
Hvidovre University Hospital
Investigators
Study Director: Jens-Ulrik S Jensen, MD, PhD Dept. of Clinical Microbiology, Hvidovre University Hospital & Copenhagen HIV Programme (CHIP), Faculty of Health Sciences, University of Copenhagen
  More Information

No publications provided by Danish Procalcitonin Study Group

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Jens-Ulrik Jensen/ MD, Copenhagen HIV Programme, Faculty of Health Sciences, University of Copenhagen
ClinicalTrials.gov Identifier: NCT00271752     History of Changes
Other Study ID Numbers: PASS
Study First Received: January 1, 2006
Last Updated: March 3, 2010
Health Authority: Denmark: National Board of Health

Keywords provided by Danish Procalcitonin Study Group:
Procalcitonin
Sepsis
Intensive Care Unit
Sepsis and Complications
Organ Failure

Additional relevant MeSH terms:
Focal Infection
Multiple Organ Failure
Sepsis
Toxemia
Infection
 Shock
Pathologic Processes
Systemic Inflammatory Response Syndrome
Inflammation

ClinicalTrials.gov processed this record on June 18, 2013