Venous Site for Central Catheterization

NCT ID: NCT01479153

Last Updated: 2016-08-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

3471 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2015-02-28

Brief Summary

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Central venous catheters are needed in the critical care setting to administer drugs. Three sites are available to gain vascular access: subclavian, internal jugular and femoral. Each site has complications, but there is no randomized controlled study which compared the 3 sites.

The investigators hypothesis is that subclavian catheterization reduces the risk of major complications compared to internal jugular or femoral.

Detailed Description

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Conditions

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Critical Care Catheterization ICU

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Subclavian catheterization

Group Type ACTIVE_COMPARATOR

Randomization of the site for catheterization

Intervention Type PROCEDURE

Ultra-sound guided insertion strongly recommended

Internal Jugular catheterization

Group Type ACTIVE_COMPARATOR

Randomization of the site for catheterization

Intervention Type PROCEDURE

Ultra-sound guided insertion strongly recommended

Femoral Catheterization

Group Type ACTIVE_COMPARATOR

Randomization of the site for catheterization

Intervention Type PROCEDURE

Ultra-sound guided insertion strongly recommended

Interventions

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Randomization of the site for catheterization

Ultra-sound guided insertion strongly recommended

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patient admitted in the Intensive Care Unit
* Requiring Central Venous Catheterization

Exclusion Criteria

* Patients with only one site available
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Caen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean-Jacques Parienti, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

CHU CAEN

Locations

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Medical Intensive Care Unit, CHU Caen

Caen, , France

Site Status

Surgical Intensive Care Unit, CHU Caen

Caen, , France

Site Status

Medical Intensive Care Unit, Cochin, AP-HP

Paris, , France

Site Status

Médical Intensive Care Unit, Lariboisière, AP-HP

Paris, , France

Site Status

Polyvalent Intensive Care Unit, Mémorial France Etats-Unis

Saint-Lô, , France

Site Status

Countries

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France

References

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Parienti JJ, Mongardon N, Megarbane B, Mira JP, Kalfon P, Gros A, Marque S, Thuong M, Pottier V, Ramakers M, Savary B, Seguin A, Valette X, Terzi N, Sauneuf B, Cattoir V, Mermel LA, du Cheyron D; 3SITES Study Group. Intravascular Complications of Central Venous Catheterization by Insertion Site. N Engl J Med. 2015 Sep 24;373(13):1220-9. doi: 10.1056/NEJMoa1500964.

Reference Type RESULT
PMID: 26398070 (View on PubMed)

Pages J, Hazera P, Megarbane B, du Cheyron D, Thuong M, Dutheil JJ, Valette X, Fournel F, Mermel LA, Mira JP, Daubin C, Parienti JJ; 3SITES Study Group. Comparison of alcoholic chlorhexidine and povidone-iodine cutaneous antiseptics for the prevention of central venous catheter-related infection: a cohort and quasi-experimental multicenter study. Intensive Care Med. 2016 Sep;42(9):1418-26. doi: 10.1007/s00134-016-4406-4. Epub 2016 Jun 16.

Reference Type RESULT
PMID: 27311311 (View on PubMed)

Iachkine J, Buetti N, de Grooth HJ, Briant AR, Mimoz O, Megarbane B, Mira JP, Valette X, Daubin C, du Cheyron D, Mermel LA, Timsit JF, Parienti JJ. Development and validation of a multivariable model predicting the required catheter dwell time among mechanically ventilated critically ill patients in three randomized trials. Ann Intensive Care. 2023 Jan 16;13(1):5. doi: 10.1186/s13613-023-01099-9.

Reference Type DERIVED
PMID: 36645531 (View on PubMed)

Iachkine J, Buetti N, de Grooth HJ, Briant AR, Mimoz O, Megarbane B, Mira JP, Ruckly S, Souweine B, du Cheyron D, Mermel LA, Timsit JF, Parienti JJ. Development and validation of a multivariable prediction model of central venous catheter-tip colonization in a cohort of five randomized trials. Crit Care. 2022 Jul 7;26(1):205. doi: 10.1186/s13054-022-04078-x.

Reference Type DERIVED
PMID: 35799302 (View on PubMed)

Other Identifiers

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ID RCB 2010-A00813-36

Identifier Type: -

Identifier Source: org_study_id

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