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Procedure
Central Venous Catheter Techniques for Shock
Phase 4
Recruiting
Led By Benjamin J Friedman, MD
Research Sponsored by Montefiore Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 20 minutes
Awards & highlights
Pivotal Trial
No Placebo-Only Group
Drug Has Already Been Approved
Summary
This trial will compare the safety and effectiveness of two different techniques for placing a central venous catheter.
Who is the study for?
This trial is for adult patients in the emergency department who need a central venous catheter placed using ultrasound guidance. People with existing catheters that could interfere, blood clotting issues, low platelet counts, previous central lines at the same site, or conditions affecting consent are not eligible.
What is being tested?
The study compares two different techniques of inserting a central venous catheter to see which one might be better. Patients will receive one of these techniques when they require a central line during their emergency care.
What are the potential side effects?
Potential side effects from central line insertion include bleeding, infection at the insertion site, injury to nearby structures like arteries or nerves, and complications related to incorrect placement.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 20 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~20 minutes
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Only 1 attempt
Secondary study objectives
Number of attempts
Interventional procedure
Unable to place central line
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Peripheral IVExperimental Treatment1 Intervention
A peripheral intravenous catheter will be used to obtain initial central venous access
Group II: Standard techniqueActive Control1 Intervention
The conventional hollow bore needle on a syringe will be used
Find a Location
Who is running the clinical trial?
Montefiore Medical CenterLead Sponsor
457 Previous Clinical Trials
588,461 Total Patients Enrolled
2 Trials studying Shock
1,751 Patients Enrolled for Shock
Benjamin J Friedman, MDPrincipal InvestigatorMontefiore Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a blood disorder affecting clotting, but I can take aspirin.
Research Study Groups:
This trial has the following groups:- Group 1: Standard technique
- Group 2: Peripheral IV
Awards:
This trial has 3 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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