NCT00271752

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 1, 2006

Completed
Same day until next milestone

Study Start

First participant enrolled

January 1, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 4, 2006

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

March 4, 2010

Status Verified

March 1, 2010

Enrollment Period

3.7 years

First QC Date

January 1, 2006

Last Update Submit

March 3, 2010

Conditions

Localized InfectionSepsisMultiple Organ Failure

Keywords

ProcalcitoninSepsisIntensive Care UnitSepsis and ComplicationsOrgan Failure

Outcome Measures

Primary Outcomes (1)

  • mortality/survival

    28 day

Secondary Outcomes (12)

  • mortality/survival

    60 day

  • mortality/survival

    90 day

  • mortality/survival

    120 day

  • mortality/survival

    180 day

  • Consumption of antimicrobial chemotherapy

    28 day

  • +7 more secondary outcomes

Study Arms (2)

PCT guided

EXPERIMENTAL

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

Control

SHAM COMPARATOR

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

Procedure: Earlier therapeutic changes regarding infection

Interventions

Earlier therapeutic changes regarding infectionPROCEDURE

For every day Procalcitonin levels increase in the intervention group, antibiotics, surgery, diagnostic imaging and microbiologic testing is intensified

ControlPCT guided

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Intensive Care Unit, Århus Sygehus, Nørrebrogade

Aarhus, Central Jutland, DK-8000, Denmark

Location

Skejby Sygehus

Skejby, Århus, Central Jutland, DK-8200, Denmark

Location

Intensive Care Unit, Bispebjerg Hospital

Copenhagen NV, Copenhagen, DK-2400, Denmark

Location

Intensive Care Unit, KAS Gentofte

Gentofte Municipality, Copenhagen, DK-2820, Denmark

Location

Intensive Care Unit, KAS Glostrup, Copenhagen University Hospital

Glostrup Municipality, Copenhagen, DK-2600, Denmark

Location

Intensive Care Unit, Herlev Hospital

Herlev, Copenhagen, DK-2730, Denmark

Location

Intensive Care Unit 542, Hvidovre Hospital, Copenhagen University Hospital

Hvidovre, Copenhagen, DK-2650, Denmark

Location

Intensive Care Unit, Hilleroed Sygehus

Hilleroed, Frederiksborg County, DK-3400, Denmark

Location

Roskilde Sygehus

Roskilde, Region Sjælland, DK-4000, Denmark

Location

Related Publications (7)

  • 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.

    PMID: 30339635DERIVED

  • 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.

    PMID: 27873291DERIVED

  • 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.

    PMID: 25590523DERIVED

  • 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.

    PMID: 24312305DERIVED

  • 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.

    PMID: 22411933DERIVED

  • 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.

    PMID: 21572328DERIVED

  • 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.

    PMID: 18620598DERIVED

MeSH Terms

Conditions

Focal InfectionSepsisMultiple Organ Failure

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Study Officials

  • Jens-Ulrik S Jensen, MD, PhD

    Dept. of Clinical Microbiology, Hvidovre University Hospital & Copenhagen HIV Programme (CHIP), Faculty of Health Sciences, University of Copenhagen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 1, 2006

First Posted

January 4, 2006

Study Start

January 1, 2006

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

March 4, 2010

Record last verified: 2010-03

Locations

DK(9)