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The Procalcitonin and Survival Study (PASS)

Primary Purpose

Localized Infection, Sepsis, Multiple Organ Failure

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Earlier therapeutic changes regarding infection
Sponsored by
Danish Procalcitonin Study Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Localized Infection focused on measuring Procalcitonin, Sepsis, Intensive Care Unit, Sepsis and Complications, Organ Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Fulfilment of all of the following three criteria: Male or female, aged > 18 years of age. 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 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: 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. 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. 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.

Sites / Locations

  • Intensive Care Unit, Bispebjerg Hospital
  • Intensive Care Unit, KAS Gentofte
  • Intensive Care Unit, KAS Glostrup, Copenhagen University Hospital
  • Intensive Care Unit, Herlev Hospital
  • Intensive Care Unit 542, Hvidovre Hospital, Copenhagen University Hospital
  • Intensive Care Unit, Hilleroed Sygehus
  • Skejby Sygehus
  • Intensive Care Unit, Århus Sygehus, Nørrebrogade
  • Roskilde Sygehus

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

PCT guided

Control

Arm Description

Procalcitonin guided treatment of infections in the ICU. Intervention: Intensification of antibiotics, surgery, microbiologic testing and diagnostic imaging, when Procalcitonin levels are increasing

These patients receive "Standard of Care" which is the recommended treatment in the given ICU

Outcomes

Primary Outcome Measures

mortality/survival

Secondary Outcome Measures

mortality/survival
mortality/survival
mortality/survival
mortality/survival
Consumption of antimicrobial chemotherapy
Prevalence of complications to infection: sepsis
severe sepsis
septic shock
Multi Organ Dysfunction Syndrome
Disseminated Intravascular Coagulation
use of diagnostic imaging during admission to the ICU
Quality of life post-ICU

Full Information

First Posted
January 1, 2006
Last Updated
March 3, 2010
Sponsor
Danish Procalcitonin Study Group
Collaborators
Copenhagen HIV Programme, Danish Research Agency, Hvidovre University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00271752
Brief Title
The Procalcitonin and Survival Study
Acronym
PASS
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Danish Procalcitonin Study Group
Collaborators
Copenhagen HIV Programme, Danish Research Agency, Hvidovre University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Localized Infection, Sepsis, Multiple Organ Failure
Keywords
Procalcitonin, Sepsis, Intensive Care Unit, Sepsis and Complications, Organ Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
1200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PCT guided
Arm Type
Experimental
Arm Description
Procalcitonin guided treatment of infections in the ICU. Intervention: Intensification of antibiotics, surgery, microbiologic testing and diagnostic imaging, when Procalcitonin levels are increasing
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
These patients receive "Standard of Care" which is the recommended treatment in the given ICU
Intervention Type
Procedure
Intervention Name(s)
Earlier therapeutic changes regarding infection
Intervention Description
For every day Procalcitonin levels increase in the intervention group, antibiotics, surgery, diagnostic imaging and microbiologic testing is intensified
Primary Outcome Measure Information:
Title
mortality/survival
Time Frame
28 day
Secondary Outcome Measure Information:
Title
mortality/survival
Time Frame
60 day
Title
mortality/survival
Time Frame
90 day
Title
mortality/survival
Time Frame
120 day
Title
mortality/survival
Time Frame
180 day
Title
Consumption of antimicrobial chemotherapy
Time Frame
28 day
Title
Prevalence of complications to infection: sepsis
Time Frame
28 day
Title
severe sepsis
Time Frame
28 day
Title
septic shock
Time Frame
28 day
Title
Multi Organ Dysfunction Syndrome
Time Frame
28 day
Title
Disseminated Intravascular Coagulation
Time Frame
28 day
Title
use of diagnostic imaging during admission to the ICU
Time Frame
28 day
Title
Quality of life post-ICU
Time Frame
180 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Fulfilment of all of the following three criteria: Male or female, aged > 18 years of age. 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 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: 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. 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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens-Ulrik S Jensen, MD, PhD
Organizational Affiliation
Dept. of Clinical Microbiology, Hvidovre University Hospital & Copenhagen HIV Programme (CHIP), Faculty of Health Sciences, University of Copenhagen
Official's Role
Study Director
Facility Information:
Facility Name
Intensive Care Unit, Bispebjerg Hospital
City
Copenhagen NV
State/Province
Copenhagen
ZIP/Postal Code
DK-2400
Country
Denmark
Facility Name
Intensive Care Unit, KAS Gentofte
City
Gentofte
State/Province
Copenhagen
ZIP/Postal Code
DK-2820
Country
Denmark
Facility Name
Intensive Care Unit, KAS Glostrup, Copenhagen University Hospital
City
Glostrup
State/Province
Copenhagen
ZIP/Postal Code
DK-2600
Country
Denmark
Facility Name
Intensive Care Unit, Herlev Hospital
City
Herlev
State/Province
Copenhagen
ZIP/Postal Code
DK-2730
Country
Denmark
Facility Name
Intensive Care Unit 542, Hvidovre Hospital, Copenhagen University Hospital
City
Hvidovre
State/Province
Copenhagen
ZIP/Postal Code
DK-2650
Country
Denmark
Facility Name
Intensive Care Unit, Hilleroed Sygehus
City
Hilleroed
State/Province
Frederiksborg County
ZIP/Postal Code
DK-3400
Country
Denmark
Facility Name
Skejby Sygehus
City
Skejby, Århus
State/Province
Midtjylland
ZIP/Postal Code
DK-8200
Country
Denmark
Facility Name
Intensive Care Unit, Århus Sygehus, Nørrebrogade
City
Århus
State/Province
Midtjylland
ZIP/Postal Code
DK-8000
Country
Denmark
Facility Name
Roskilde Sygehus
City
Roskilde
State/Province
Sjælland
ZIP/Postal Code
DK-4000
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
30339635
Citation
Holm FS, Sivapalan P, Seersholm N, Itenov TS, Christensen PH, Jensen JS. Acute Lung Injury in Critically Ill Patients: Actin-Scavenger Gelsolin Signals Prolonged Respiratory Failure. Shock. 2019 Sep;52(3):370-377. doi: 10.1097/SHK.0000000000001279.
Results Reference
derived
PubMed Identifier
27873291
Citation
Jensen JS, Itenov TS, Thormar KM, Hein L, Mohr TT, Andersen MH, Loken J, Tousi H, Lundgren B, Boesen HC, Johansen ME, Ostrowski SR, Johansson PI, Grarup J, Vestbo J, Lundgren JD; Procalcitonin And Survival Study (PASS) Group. Prediction of non-recovery from ventilator-demanding acute respiratory failure, ARDS and death using lung damage biomarkers: data from a 1200-patient critical care randomized trial. Ann Intensive Care. 2016 Dec;6(1):114. doi: 10.1186/s13613-016-0212-y. Epub 2016 Nov 21.
Results Reference
derived
PubMed Identifier
25590523
Citation
Johansen ME, Johansson PI, Ostrowski SR, Bestle MH, Hein L, Jensen AL, Soe-Jensen P, Andersen MH, Steensen M, Mohr T, Thormar K, Lundgren B, Cozzi-Lepri A, Lundgren JD, Jensen JU. Profound endothelial damage predicts impending organ failure and death in sepsis. Semin Thromb Hemost. 2015 Feb;41(1):16-25. doi: 10.1055/s-0034-1398377. Epub 2015 Jan 15.
Results Reference
derived
PubMed Identifier
24312305
Citation
Johansen ME, Jensen JU, Bestle MH, Hein L, Lauritsen AO, Tousi H, Larsen KM, Loken J, Mohr T, Thormar K, Johansson PI, Cozzi-Lepri A, Lundgren JD. The potential of antimicrobials to induce thrombocytopenia in critically ill patients: data from a randomized controlled trial. PLoS One. 2013 Nov 28;8(11):e81477. doi: 10.1371/journal.pone.0081477. eCollection 2013.
Results Reference
derived
PubMed Identifier
22411933
Citation
Jensen JU, Hein L, Lundgren B, Bestle MH, Mohr T, Andersen MH, Thornberg KJ, Loken J, Steensen M, Fox Z, Tousi H, Soe-Jensen P, Lauritsen AO, Strange DG, Reiter N, Thormar K, Fjeldborg PC, Larsen KM, Drenck NE, Johansen ME, Nielsen LR, Ostergaard C, Kjaer J, Grarup J, Lundgren JD; Procalcitonin And Survival Study (PASS) Group. Kidney failure related to broad-spectrum antibiotics in critically ill patients: secondary end point results from a 1200 patient randomised trial. BMJ Open. 2012 Mar 11;2(2):e000635. doi: 10.1136/bmjopen-2011-000635. Print 2012.
Results Reference
derived
PubMed Identifier
21572328
Citation
Jensen JU, Hein L, Lundgren B, Bestle MH, Mohr TT, Andersen MH, Thornberg KJ, Loken J, Steensen M, Fox Z, Tousi H, Soe-Jensen P, Lauritsen AO, Strange D, Petersen PL, Reiter N, Hestad S, Thormar K, Fjeldborg P, Larsen KM, Drenck NE, Ostergaard C, Kjaer J, Grarup J, Lundgren JD; Procalcitonin And Survival Study (PASS) Group. Procalcitonin-guided interventions against infections to increase early appropriate antibiotics and improve survival in the intensive care unit: a randomized trial. Crit Care Med. 2011 Sep;39(9):2048-58. doi: 10.1097/CCM.0b013e31821e8791.
Results Reference
derived
PubMed Identifier
18620598
Citation
Jensen JU, Lundgren B, Hein L, Mohr T, Petersen PL, Andersen LH, Lauritsen AO, Hougaard S, Mantoni T, Bomler B, Thornberg KJ, Thormar K, Loken J, Steensen M, Carl P, Petersen JA, Tousi H, Soe-Jensen P, Bestle M, Hestad S, Andersen MH, Fjeldborg P, Larsen KM, Rossau C, Thomsen CB, Ostergaard C, Kjaer J, Grarup J, Lundgren JD. The Procalcitonin And Survival Study (PASS) - a randomised multi-center investigator-initiated trial to investigate whether daily measurements biomarker Procalcitonin and pro-active diagnostic and therapeutic responses to abnormal Procalcitonin levels, can improve survival in intensive care unit patients. Calculated sample size (target population): 1000 patients. BMC Infect Dis. 2008 Jul 13;8:91. doi: 10.1186/1471-2334-8-91.
Results Reference
derived

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The Procalcitonin and Survival Study

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