Clinical trial NCT03017911: COMPLI-PICC: Study on Picclines' Complications
Official title: Prospective Observational Study on Picclines' Complications at Brest Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: PICC Line Placement
Keywords: PICC Line
Complications
Thrombosis
Infection
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2017-01-11
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients \> 18 yo from internal medicine, pneumology, nutrition, oncology, hematology, and cardiac and vascular surgery - who underwent PICC Line placement between October 10, 2016 and March 9, 2017 will be included in the study.

Brief summary: This is a prospective monocentric study of PICC Line complications use in 5 medical and one surgical units of Brest Medical University Hospital.

To evaluate the incidence of the following complications: infections, thromboses, mechanical and hemorrhagic, at month 3 post-intervention.

Also evaluating:

* the management of these PICC Line related complications,
* risk factors for such complications,
* and the mortality-related outcomes.

Detailed description: All eligible patients fulfilling the inclusion criteria, after PICC Line placement, will receive oral and written patient information describing the study deployment and follow-up. Patients will be followed up until PICC Line removal if it occurs during the first 3 months after placement or until death if it occurs during the first 3 months, or during 3 months in the absence of complications.

* Infectious complications are described in accordance with IDSA 2009 guidelines and include bloodstream infection, endocarditis, local infection and septic thrombophlebitis.
* Thrombotic complications are defined as symptomatic, deep, or superficial venous thrombosis, confirmed by Ultrasound and Echo-Doppler or asymptomatic venous thrombosis diagnosed fortuitously.
* Mechanical complications are defined as impairments related to PICC Line device: occlusion, rupture, accidental removal.
* Hemorrhagic complications are defined as hematoma or bleedings of puncture site.

In the event of PICC Line-related complications, patient will be followed up for an additional 3 months, from the date of complication diagnosis, i.e. maximum follow-up duration of 6 months.

Each week during the first month, then once monthly during the follow-up (i.e. W1, W2, W3, W4, M2, M3, +/- M4, M5, M6), all patients data related to the PICC Line retention or removal, use and all its related complications will be collected.

Eligibility criteria: Inclusion Criteria:

* Patient \> 18 yo
* Patients \> 18 yo hospitalized in internal medicine, pneumology, nutrition, oncology, hematology, and cardiac and vascular surgery - who underwent PICC Line placement between October 10, 2016 and March 9, 2017

Exclusion Criteria:

* Patients hospitalized in other units than those cited above
* Patients verbal refusal to participate in the study

Primary outcomes:
measure: Complication in patient with piccline
timeFrame: 3 month
Secondary outcomes:
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
Study officials:
References:
citation: Mermel LA, Allon M, Bouza E, Craven DE, Flynn P, O'Grady NP, Raad II, Rijnders BJ, Sherertz RJ, Warren DK. Clinical practice guidelines for the diagnosis and management of intravascular catheter-related infection: 2009 Update by the Infectious Diseases Society of America. Clin Infect Dis. 2009 Jul 1;49(1):1-45. doi: 10.1086/599376.
citation: O'Grady NP, Alexander M, Burns LA, Dellinger EP, Garland J, Heard SO, Lipsett PA, Masur H, Mermel LA, Pearson ML, Raad II, Randolph AG, Rupp ME, Saint S; Healthcare Infection Control Practices Advisory Committee. Guidelines for the prevention of intravascular catheter-related infections. Am J Infect Control. 2011 May;39(4 Suppl 1):S1-34. doi: 10.1016/j.ajic.2011.01.003. No abstract available.
citation: Safdar N, Maki DG. Risk of catheter-related bloodstream infection with peripherally inserted central venous catheters used in hospitalized patients. Chest. 2005 Aug;128(2):489-95. doi: 10.1378/chest.128.2.489.
citation: Chopra V, Ratz D, Kuhn L, Lopus T, Chenoweth C, Krein S. PICC-associated bloodstream infections: prevalence, patterns, and predictors. Am J Med. 2014 Apr;127(4):319-28. doi: 10.1016/j.amjmed.2014.01.001. Epub 2014 Jan 17.
citation: Chemaly RF, de Parres JB, Rehm SJ, Adal KA, Lisgaris MV, Katz-Scott DS, Curtas S, Gordon SM, Steiger E, Olin J, Longworth DL. Venous thrombosis associated with peripherally inserted central catheters: a retrospective analysis of the Cleveland Clinic experience. Clin Infect Dis. 2002 May 1;34(9):1179-83. doi: 10.1086/339808. Epub 2002 Apr 3.
citation: Vidal V, Muller C, Jacquier A, Giorgi R, Le Corroller T, Gaubert J, Champsaur P, Bartoli J, Moulin G. [Prospective evaluation of PICC line related complications]. J Radiol. 2008 Apr;89(4):495-8. doi: 10.1016/s0221-0363(08)71453-7. French.