NCT03834675

Brief Summary

Peripherally inserted central catheters (PICCs) are increasingly used in intensive care unit (ICU) as an alternative to centrally inserted central catheters (CICCs) for intravenous infusion. In the present study we try to assess their reliability for measuring cardiac index (CI) with trans-pulmonary thermodilution (TPTD) technique.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

June 1, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2019

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

February 5, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 8, 2019

Completed
Last Updated

January 27, 2020

Status Verified

February 1, 2019

Enrollment Period

7 months

First QC Date

February 5, 2019

Last Update Submit

January 22, 2020

Conditions

Keywords

PICCshockcardiac output

Outcome Measures

Primary Outcomes (1)

  • Cardiac Index comparison via PICC

    comparison of hemodynamic measurements made by the TPTD from the VolumeView/EV1000TM system via PICC vs. CICC.

    One hour

Secondary Outcomes (2)

  • Comparison 4Fr PICCs to CICC

    one hour

  • Comparison 5Fr PICCs to CICC

    one hour

Interventions

Thermodilution was attempted via PICC and via CICC

Eligibility Criteria

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

You may qualify if:

  • adult patients (≥18 years) admitted to the ICU
  • Patients requiring hemodynamic monitoring using EV1000TM
  • Patients having both PICC and CICC in place (these patients had their PICC replaced with a CICC, usually at the time of ICU admission, or vice versa, usually at the end of their ICU stay, and were enrolled immediately after the placement of the new device before the previous one was removed)

You may not qualify if:

  • body weight \<40 kg
  • severe aortic regurgitation or intra-cardiac shunt
  • treatment with an intra-aortic balloon pump
  • contraindication for placement of PICC, CICC or a femoral arterial catheter
  • abdominal aneurism
  • extracorporeal circulation
  • pregnancy
  • lack of informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, 00168, Italy

Location

Related Publications (1)

  • D'Arrigo S, Sandroni C, Cacciola S, Dell'Anna AM, Pittiruti M, Annetta MG, Colosimo C, Antonelli M. Are Peripherally Inserted Central Catheters Suitable for Cardiac Output Assessment With Transpulmonary Thermodilution? Crit Care Med. 2019 Oct;47(10):1356-1361. doi: 10.1097/CCM.0000000000003917.

MeSH Terms

Conditions

Shock

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Massimo Antonelli, MD

    Università Cattolica del sacro Cuore- Fondazione Policlinico Universitario A. Gemelli IRCSS

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor - PhD

Study Record Dates

First Submitted

February 5, 2019

First Posted

February 8, 2019

Study Start

June 1, 2018

Primary Completion

December 31, 2018

Study Completion

January 31, 2019

Last Updated

January 27, 2020

Record last verified: 2019-02

Locations