Effects of Voluven on Hemodynamics and Tolerability of Enteral Nutrition in Patients With Severe Sepsis
NCT ID: NCT00464204
Last Updated: 2012-01-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
196 participants
INTERVENTIONAL
2007-07-31
2010-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Voluven® Arm
6 % Hydroxyethylstarch 130/0.4 = "Voluven®"
Voluven® was administered intravenously. Voluven® rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day on the second to fourth days, according to patient needs.
0.9 % NaCl
0.9 % NaCl
NaCl 0.9 % was administered intravenously. NaCl 0.9% rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day, according to patient needs.
Interventions
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6 % Hydroxyethylstarch 130/0.4 = "Voluven®"
Voluven® was administered intravenously. Voluven® rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day on the second to fourth days, according to patient needs.
0.9 % NaCl
NaCl 0.9 % was administered intravenously. NaCl 0.9% rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day, according to patient needs.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Requirement for fluid resuscitation
Exclusion Criteria
* Chronic renal failure
* Anuria lasting more than 4 hours
* Requirement for renal support
18 Years
ALL
No
Sponsors
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Fresenius Kabi
INDUSTRY
Responsible Party
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Principal Investigators
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Bertrand Guidet, Prof., MD
Role: STUDY_CHAIR
Hôpital St Antoine, Réanimation Médicale
Locations
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Hôpital Sud, Unité de Réanimation Médicale
Amiens, , France
Centre Hospitalier d'Avignon, Service de Réanimation Polyvalente
Avignon, , France
Centre Hospitalier de Belfort-Montbéliard, Service de Réanimation et Maladies Infectieuses, Site de Belfort
Belfort, , France
CHU de Bicêtre, Dpt d'Anesthésie Réanimation Chir.
Bicêtre, , France
Hôpital Avicenne, Service de Réanimation
Bobigny, , France
Centre Hospitalier Fleyriat, Service de Réanimation Polyvalente
Bourg-en-Bresse, , France
CH Manchester, Service de Réanimation Polyvalente
Charleville-Mézières, , France
CH Sud Francilien, Site Gilles de Corbeil, Réanimation Polyvalente
Corbeil-Essonnes, , France
CHU de Dijon - Hôpital du Bocage Service de Réanimation Médicale
Dijon, , France
CH Meaux, Service de Réanimation
Meaux, , France
Centre Hospitalier de Metz, Réa Polyvalente
Metz, , France
Hôpital Lapeyronie / CHU Montpellier, Département d'Anesthésie Réanimation
Montpellier, , France
Hôpital Central, Service Anesthésie-Réanimation, Chirurgicale CHU
Nancy, , France
CHU Nîmes, Service de Réanimation, Division Anesthésie-Réa Douleur Urgence, Groupe Hospitalo-Universitaire Caremeau,
Nîmes, , France
Hôpital de la Source, Réanimation Polyvalente
Orléans, , France
Hôpital St Louis, Département Anesthésie et Réanimation Chirurgicale
Paris, , France
Hôpital Saint-Joseph, Service de Réanimation Polyvalente
Paris, , France
Hôpital St Antoine, Réanimation Médicale
Paris, , France
CH Roanne, Service de Réanimation
Roanne, , France
CHI Poissy - St Germain en Laye, Site de St Germain en Laye
Saint-Germain-en-Laye, , France
Hôpital Civil de Strasbourg, Service de Réanimation Médicale
Strasbourg, , France
Klinik und Poliklinik für Anästhesiologie und Intensivtherapie - Universitätsklinikum Leipzig AöR
Leipzig, , Germany
Klinik und Poliklinik für Anästhesiologie und operative Intensivmedizin der Westf. Wilhelms-Universität
Münster, , Germany
Universitätsklinikum Tübingen, Klinik für Anästhesiologie und Intensivmedizin
Tübingen, , Germany
Countries
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References
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Guidet B, Martinet O, Boulain T, Philippart F, Poussel JF, Maizel J, Forceville X, Feissel M, Hasselmann M, Heininger A, Van Aken H. Assessment of hemodynamic efficacy and safety of 6% hydroxyethylstarch 130/0.4 vs. 0.9% NaCl fluid replacement in patients with severe sepsis: the CRYSTMAS study. Crit Care. 2012 May 24;16(3):R94. doi: 10.1186/cc11358.
Other Identifiers
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2006-004350-25
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
06-HE06-01
Identifier Type: -
Identifier Source: org_study_id
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