NCT04140916

Brief Summary

Central venous catheters are routinely used, however, with a complication rate exceeding 15%. Therefore, other types of venous catheters have been introduced such as a midline catheter. The purpose of the present study is to assess the efficacy and the safety of midline catheters compared to the standard care being a central catheter also inserted peripherally. Patients with indication for intravenous fluids or medicines for 5 to 28 days will be included in the study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
304

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2018

Longer than P75 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

October 7, 2018

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

October 18, 2019

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 28, 2019

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

July 15, 2024

Status Verified

July 1, 2024

Enrollment Period

3.7 years

First QC Date

October 18, 2019

Last Update Submit

July 12, 2024

Conditions

Catheter-Related InfectionsCatheter Related Complication

Outcome Measures

Primary Outcomes (1)

  • Number of catheter related blood infection

    Clinical signs of infection (i.e. fever, chills, leukocytosis or hypotension) and at least one positive blood culture.

    Up to 28 days

Secondary Outcomes (6)

  • Number of deep venous thrombosis

    Up to 28 days

  • Number of catheter failure

    Up to 28 days

  • Score of phlebitis

    Up to 28 days

  • Score of infiltration at the puncture site

    Up to 28 days

  • Score of pain in relation to fluid or drug administration

    Up to 28 days

  • +1 more secondary outcomes

Study Arms (2)

Midline catheter

EXPERIMENTAL

Insertion of a Midline catheter in patients scheduled for insertion of a catheter for intravenous fluids or medicines with an expected length of treatment between 5 and 28 days will

Device: Midline catheter

PICC-line catheter

ACTIVE COMPARATOR

Insertion of a Midline catheter in patients scheduled for insertion of a catheter for intravenous fluids or medicines with an expected length of treatment between 5 and 28 days will

Device: PICC-line catheter

Interventions

Midline catheterDEVICE

Peripherally inserted short intravenous catheter

Midline catheter
PICC-line catheterDEVICE

Peripherally inserted long intravenous catheter

PICC-line catheter

Eligibility Criteria

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

You may qualify if:

  • Indication for intravenous medicine or fluids included in the following:
  • Blood products, isotonic saline- or glucose-solutions (including glucose-insulin-potassium-solutions)
  • Antibiotics (penicillins, cephalosporins, carbapenems or fluoroquinolones)
  • Chemotherapy registered for use in a peripheral vein catheter
  • Expected indication for intravenous access in 5 to 28 days
  • Informed consent

You may not qualify if:

  • Infection or burns at both upper extremities (Involving the area of puncture site)
  • Pregnancy (Confirmed by positive urine human gonadotropin (hCG) or plasma-hCG)
  • A central venous catheter already in place (Self-explanatory)
  • Earlier randomized to the study (Self-explanatory)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aalborg University Hospital

Aalborg, 9000, Denmark

Location

Related Publications (1)

  • Thomsen SL, Boa R, Vinter-Jensen L, Rasmussen BS. Safety and Efficacy of Midline vs Peripherally Inserted Central Catheters Among Adults Receiving IV Therapy: A Randomized Clinical Trial. JAMA Netw Open. 2024 Feb 5;7(2):e2355716. doi: 10.1001/jamanetworkopen.2023.55716.

    PMID: 38349655BACKGROUND

MeSH Terms

Conditions

Catheter-Related Infections

Condition Hierarchy (Ancestors)

Infections

Study Officials

  • Bodil S Rasmussen, MD

    Aalborg University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The statistical analyses of the outcomes will be performed by a statistician being blinded.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Patients will be randomized to either the control Group (PICC-line catheter) or the intervention Group (Midline catheter) using an online Tool (Research Electronic Data Capture (REDCap), Aarhus University, Denmark).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

October 18, 2019

First Posted

October 28, 2019

Study Start

October 7, 2018

Primary Completion

June 30, 2022

Study Completion

December 31, 2022

Last Updated

July 15, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Individual participant data would be available to other researchers depending on compliance with legislation in connection with the transfer of data.

Locations

DK(1)