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A Randomized Controlled Trial

Jacques Merrer, MD; Bernard De Jonghe, MD; Franck Golliot, MS; Jean-Yves Lefrant, MD; Brigitte Raffy, MD; Eric Barre, MD; Jean-Philippe Rigaud, MD; Dominique Casciani, MD; Benoît Misset, MD; Christophe Bosquet, MD; Hervé Outin, MD; Christian Brun-Buisson, MD; Gérard Nitenberg, MD; for the French Catheter Study Group in Intensive Care

JAMA. 2001;286:700-707.

Context  Whether venous catheterization at the femoral site is associated with an increased risk of complications compared with that at the subclavian site is debated.

Objective  To compare mechanical, infectious, and thrombotic complications of femoral and subclavian venous catheterization.

Design and Setting  Concealed, randomized controlled clinical trial conducted between December 1997 and July 2000 at 8 intensive care units (ICUs) in France.

Patients  Two hundred eighty-nine adult patients receiving a first central venous catheter.

Interventions  Patients were randomly assigned to undergo central venous catheterization at the femoral site (n = 145) or subclavian site (n = 144).

Main Outcome Measures  Rate and severity of mechanical, infectious, and thrombotic complications, compared by catheterization site in 289, 270, and 223 patients, respectively.

Results  Femoral catheterization was associated with a higher incidence rate of overall infectious complications (19.8% vs 4.5%; P<.001; incidence density of 20 vs 3.7 per 1000 catheter-days) and of major infectious complications (clinical sepsis with or without bloodstream infection, 4.4% vs 1.5%; P = .07; incidence density of 4.5 vs 1.2 per 1000 catheter-days), as well as of overall thrombotic complications (21.5% vs 1.9%; P<.001) and complete thrombosis of the vessel (6% vs 0%; P = .01); rates of overall and major mechanical complications were similar between the 2 groups (17.3% vs 18.8 %; P = .74 and 1.4% vs 2.8%; P = .44, respectively). Risk factors for mechanical complications were duration of insertion (odds ratio [OR], 1.05; 95% confidence interval [CI], 1.03-1.08 per additional minute; P<.001); insertion in 2 of the centers (OR, 4.52; 95% CI, 1.81-11.23; P = .001); and insertion during the night (OR, 2.06; 95% CI, 1.04-4.08; P = .03). The only factor associated with infectious complications was femoral catheterization (hazard ratio [HR], 4.83; 95% CI, 1.96-11.93; P<.001); antibiotic administration via the catheter decreased risk of infectious complications (HR, 0.41; 95% CI, 0.18-0.93; P = .03). Femoral catheterization was the only risk factor for thrombotic complications (OR, 14.42; 95% CI, 3.33-62.57; P<.001).

Conclusion  Femoral venous catheterization is associated with a greater risk of infectious and thrombotic complications than subclavian catheterization in ICU patients.

Author Affiliations: Service de Réanimation Médicale (Drs Merrer, De Jonghe, and Outin) and Service de Réanimation Chirurgicale (Dr Raffy), Centre Hospitalier de Poissy/St Germain-en-Laye, Poissy, France; Centre de Coordination et de Lutte Contre les Infections Nosocomiales de Paris-Nord (Mr Golliot) and Service de Réanimation Polyvalente, Hôpital Saint Joseph (Dr Misset), Paris, France; Département d'Urgence Réanimation, Centre Hospitalo-Universitaire de Nîmes, Nîmes, France (Dr Lefrant); Service de Réanimation Polyvalente, Centre Hospitalier de Mantes-la-Jolie, Mantes-la-Jolie, France (Dr Barre); Service de Réanimation Médicale, Centre Hospitalier de Dieppe, Dieppe, France (Dr Rigaud); Service de Réanimation Polyvalente, Centre Hospitalier de Villeneuve-Saint-Georges, Villeneuve-Saint-Georges, France (Dr Casciani); Service de Réanimation Médicale, Centre Hospitalo-Universitaire de Strasbourg, Strasbourg, France (Dr Bosquet); Service de Réanimation Médicale, Centre Hospitalo-Universitaire Henri Mondor, Creteil, France (Dr Brun-Buisson); and Service de Réanimation Medico-Chirurgicale, Institut Gustave-Roussy, Villejuif, France (Dr Nitenberg).

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