Effects of Voluven on Hemodynamics and Tolerability of Enteral Nutrition in Patients With Severe Sepsis
CRYSTMAS
2 other identifiers
interventional
196
2 countries
24
Brief Summary
The rapidity and the quality of fluid resuscitation in patients with severe sepsis are important factors for the prevention of secondary multi-organ failure. Vascular filling may also have an impact on tolerability of enteral nutrition. The earliness and quantity of calories provided by enteral nutrition may have an impact on morbidity and mortality. This study will asses the effects of volume expansion on hemodynamics and tolerability of enteral nutrition in patients with severe sepsis. A Data Monitoring Committee will review regularly safety data of the study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 sepsis
Started Jul 2007
Typical duration for phase_3 sepsis
24 active sites
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
First Submitted
Initial submission to the registry
April 20, 2007
CompletedFirst Posted
Study publicly available on registry
April 23, 2007
CompletedStudy Start
First participant enrolled
July 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedResults Posted
Study results publicly available
August 2, 2011
CompletedJanuary 11, 2012
August 1, 2011
2.8 years
April 20, 2007
May 30, 2011
January 9, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Amount of Study Drug Required to Achieve Initial Hemodynamic Stabilization
Initial hemodynamic stabilization (HDS) was defined as normalization of mean arterial pressure (MAP) and at least two of the three parameters central venous pressure (CVP), urine output and central venous oxygen saturation and maintaining this normalization over a period of four hours, with no increase in the infusion of vasopressors, or ionotropic therapy and with no more than 1 L of additional study drug administration within these four hours.
until hemodynamic stabilization (up to 48 hours)
Secondary Outcomes (9)
Time From Start of Fluid Resuscitation With Study Drug to the Initial Hemodynamic Stabilization
until hemodynamic stabilization (up to 48 hours)
Quantity of Study Drug in 4 Days
4 days
Time From Start of Study Drug to Start of Enteral Nutrition in the Subgroup of Patients Who Received Enteral Nutrition
Until start of enteral nutrition (up to 48 hours)
Time From Start of Fluid Resuscitation With Study Drug to Start of Enteral Nutrition After Hemodynamic Stabilization
up to 48 hours
Total Amount of Enteral Calories During the First Seven Days of Enteral Nutrition
7 days
- +4 more secondary outcomes
Other Outcomes (4)
Mortality
From Screening to end of Follow-up
Changes in Renal Function: 1. Acute Renal Failure (ARF) at Any Time After Screening
From screening to end of follow-up (up to day 90)
Changes in Renal Function: 2. Acute Kidney Injury Network (AKIN) Classification
From screening to end of follow-up
- +1 more other outcomes
Study Arms (2)
Voluven® Arm
EXPERIMENTAL0.9 % NaCl
ACTIVE COMPARATORInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- Severe sepsis
- Requirement for fluid resuscitation
You may not qualify if:
- serum creatinine \> 300µmol/L
- Chronic renal failure
- Anuria lasting more than 4 hours
- Requirement for renal support
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fresenius Kabilead
Study Sites (24)
Hôpital Sud, Unité de Réanimation Médicale
Amiens, 80054, France
Centre Hospitalier d'Avignon, Service de Réanimation Polyvalente
Avignon, 84902, France
Centre Hospitalier de Belfort-Montbéliard, Service de Réanimation et Maladies Infectieuses, Site de Belfort
Belfort, 90000, France
CHU de Bicêtre, Dpt d'Anesthésie Réanimation Chir.
Bicêtre, 94270, France
Hôpital Avicenne, Service de Réanimation
Bobigny, 93009, France
Centre Hospitalier Fleyriat, Service de Réanimation Polyvalente
Bourg-en-Bresse, 01012, France
CH Manchester, Service de Réanimation Polyvalente
Charleville-Mézières, 08011, France
CH Sud Francilien, Site Gilles de Corbeil, Réanimation Polyvalente
Corbeil-Essonnes, 91106, France
CHU de Dijon - Hôpital du Bocage Service de Réanimation Médicale
Dijon, 21079, France
CH Meaux, Service de Réanimation
Meaux, 77104, France
Centre Hospitalier de Metz, Réa Polyvalente
Metz, 57038, France
Hôpital Lapeyronie / CHU Montpellier, Département d'Anesthésie Réanimation
Montpellier, 34090, France
Hôpital Central, Service Anesthésie-Réanimation, Chirurgicale CHU
Nancy, 54035, France
CHU Nîmes, Service de Réanimation, Division Anesthésie-Réa Douleur Urgence, Groupe Hospitalo-Universitaire Caremeau,
Nîmes, 30029, France
Hôpital de la Source, Réanimation Polyvalente
Orléans, 45032, France
Hôpital St Louis, Département Anesthésie et Réanimation Chirurgicale
Paris, 75010, France
Hôpital Saint-Joseph, Service de Réanimation Polyvalente
Paris, 75014, France
Hôpital St Antoine, Réanimation Médicale
Paris, 7551, France
CH Roanne, Service de Réanimation
Roanne, 42328, France
CHI Poissy - St Germain en Laye, Site de St Germain en Laye
Saint-Germain-en-Laye, 78100, France
Hôpital Civil de Strasbourg, Service de Réanimation Médicale
Strasbourg, 67091, France
Klinik und Poliklinik für Anästhesiologie und Intensivtherapie - Universitätsklinikum Leipzig AöR
Leipzig, 04103, Germany
Klinik und Poliklinik für Anästhesiologie und operative Intensivmedizin der Westf. Wilhelms-Universität
Münster, 48149, Germany
Universitätsklinikum Tübingen, Klinik für Anästhesiologie und Intensivmedizin
Tübingen, 72076, Germany
Related Publications (1)
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.
PMID: 22624531DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Professor Dr. Martin Westphal
- Organization
- Fresenius Kabi Aktiengesellschaft
Study Officials
- STUDY CHAIR
Bertrand Guidet, Prof., MD
Hôpital St Antoine, Réanimation Médicale
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 20, 2007
First Posted
April 23, 2007
Study Start
July 1, 2007
Primary Completion
May 1, 2010
Study Completion
December 1, 2010
Last Updated
January 11, 2012
Results First Posted
August 2, 2011
Record last verified: 2011-08