Effects of Voluven on Hemodynamics and Tolerability of Enteral Nutrition in Patients With Severe Sepsis (CRYSTMAS)
This study has been completed.
Sponsor:
Fresenius Kabi
Information provided by (Responsible Party):
Fresenius Kabi
ClinicalTrials.gov Identifier:
NCT00464204
First received: April 20, 2007
Last updated: January 9, 2012
Last verified: August 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Sepsis |
Drug: 6 % Hydroxyethylstarch 130/0.4 = "Voluven®" Drug: 0.9 % NaCl |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Effects of Voluven on Hemodynamics and Tolerability of Enteral Nutrition in Patients With Severe Sepsis |
Resource links provided by NLM:
Further study details as provided by Fresenius Kabi:
Primary Outcome Measures:
- Amount of Study Drug Required to Achieve Initial Hemodynamic Stabilization [ Time Frame: until hemodynamic stabilization (up to 48 hours) ] [ Designated as safety issue: No ]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.
Secondary Outcome Measures:
- Time From Start of Fluid Resuscitation With Study Drug to the Initial Hemodynamic Stabilization [ Time Frame: until hemodynamic stabilization (up to 48 hours) ] [ Designated as safety issue: No ]Time from start of fluid resuscitation with study drug to the initial hemodynamic stabilization
- Quantity of Study Drug in 4 Days [ Time Frame: 4 days ] [ Designated as safety issue: No ]Total quantity of study drug infused over four consecutive days in the ICU
- Time From Start of Study Drug to Start of Enteral Nutrition in the Subgroup of Patients Who Received Enteral Nutrition [ Time Frame: Until start of enteral nutrition (up to 48 hours) ] [ Designated as safety issue: No ]Time from start of fluid resuscitation with study drug to start of enteral nutrition.
- Time From Start of Fluid Resuscitation With Study Drug to Start of Enteral Nutrition After Hemodynamic Stabilization [ Time Frame: up to 48 hours ] [ Designated as safety issue: No ]Administration of enteral nutrition before initial hemodynamic stabilization was ignored in this analysis.
- Total Amount of Enteral Calories During the First Seven Days of Enteral Nutrition [ Time Frame: 7 days ] [ Designated as safety issue: No ]This amount will be calculated from start of enteral nutrition until 7 am of day 8
- Length of Stay in the Intensive Care Unit (ICU) [ Time Frame: Until discharge from ICU (up to day 90) ] [ Designated as safety issue: No ]Length of stay was analysed in two approaches. First, it was calculated and analysed only for patients who did not die before end of study of the individual patient. As a sensitivity analysis, the analysis was carried out including patients who died with the maximum possible length of stay (i.e., the worst possible value).
- Length of Stay in the ICU [ Time Frame: Until discharge from ICU (up to Day 90) ] [ Designated as safety issue: No ]Length of stay was analysed in two approaches. First, it was calculated and analysed only for patients who did not die before end of study of the individual patient. As a sensitivity analysis, the analysis was carried out including patients who died with the maximum possible length of stay (i.e., worst possible value).
- Length of Stay in the Hospital [ Time Frame: Until discharge from hospital (up to day 90) ] [ Designated as safety issue: No ]Length of stay was analysed in two approaches. First, it was calculated and analysed only for patients who did not die before end of study of the individual patient. As a sensitivity analysis, the analysis was carried out including patients who died with the maximum possible length of stay (i.e., the worst possible value).
- Length of Stay in the Hospital [ Time Frame: Until discharge from hospital (up to Day 90) ] [ Designated as safety issue: No ]Length of stay was analysed in two approaches. First, it was calculated and analysed only for patients who did not die before end of study of the individual patient. As a sensitivity analysis, the analysis was carried out including patients who died with the maximum possible length of stay (i.e., the worst possible value).
- Area Under the Curve (AUC) of Sepsis-related Organ Failure Assessment (SOFA) Score Per Day From Screening to Day 4 [ Time Frame: From Screening to Day 4 ] [ Designated as safety issue: No ]
The Sepsis-related Organ Failure Assessment (SOFA) score in this study is reported for entire days, not for exact time points on a day. Potentially, more than one SOFA score may be available for the same day. In this case, the mean of the respective total scores was used for that day for calculation of Area Under the Curve (AUC).
The SOFA score includes sub-scores for Respiration, Coagulation, Liver, Cardiovascular, Central Nervous System and Renal function and may range from 0 (worst outcome) to 4 (best outcome).
| Enrollment: | 196 |
| Study Start Date: | July 2007 |
| Study Completion Date: | December 2010 |
| Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Voluven® Arm |
Drug: 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.
Other Name: Voluven®
|
| Active Comparator: 0.9 % NaCl |
Drug: 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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Severe sepsis
- Requirement for fluid resuscitation
Exclusion Criteria:
- serum creatinine > 300µmol/L
- Chronic renal failure
- Anuria lasting more than 4 hours
- Requirement for renal support
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00464204
Locations
| France | |
| Hôpital Sud, Unité de Réanimation Médicale | |
| Amiens, France, 80054 | |
| Centre Hospitalier d'Avignon, Service de Réanimation Polyvalente | |
| Avignon, France, 84902 | |
| Centre Hospitalier de Belfort-Montbéliard, Service de Réanimation et Maladies Infectieuses, Site de Belfort | |
| Belfort, France, 90000 | |
| CHU de Bicêtre, Dpt d'Anesthésie Réanimation Chir. | |
| Bicêtre, France, 94270 | |
| Hôpital Avicenne, Service de Réanimation | |
| Bobigny, France, 93009 | |
| Centre Hospitalier Fleyriat, Service de Réanimation Polyvalente | |
| Bourg-en-Bresse, France, 01012 | |
| CH Manchester, Service de Réanimation Polyvalente | |
| Charleville-Mézières, France, 08011 | |
| CH Sud Francilien, Site Gilles de Corbeil, Réanimation Polyvalente | |
| Corbeil-Essonnes, France, 91106 | |
| CHU de Dijon - Hôpital du Bocage Service de Réanimation Médicale | |
| Dijon, France, 21079 | |
| CH Meaux, Service de Réanimation | |
| Meaux, France, 77104 | |
| Centre Hospitalier de Metz, Réa Polyvalente | |
| Metz, France, 57038 | |
| Hôpital Lapeyronie / CHU Montpellier, Département d'Anesthésie Réanimation | |
| Montpellier, France, 34090 | |
| Hôpital Central, Service Anesthésie-Réanimation, Chirurgicale CHU | |
| Nancy, France, 54035 | |
| CHU Nîmes, Service de Réanimation, Division Anesthésie-Réa Douleur Urgence, Groupe Hospitalo-Universitaire Caremeau, | |
| Nîmes, France, 30029 | |
| Hôpital de la Source, Réanimation Polyvalente | |
| Orléans, France, 45032 | |
| Hôpital St Antoine, Réanimation Médicale | |
| Paris, France, 7551 | |
| Hôpital St Louis, Département Anesthésie et Réanimation Chirurgicale | |
| Paris, France, 75010 | |
| Hôpital Saint-Joseph, Service de Réanimation Polyvalente | |
| Paris, France, 75014 | |
| CH Roanne, Service de Réanimation | |
| Roanne, France, 42328 | |
| CHI Poissy - St Germain en Laye, Site de St Germain en Laye | |
| St. Germain en Laye, France, 78100 | |
| Hôpital Civil de Strasbourg, Service de Réanimation Médicale | |
| Strasbourg, France, 67091 | |
| Germany | |
| Klinik und Poliklinik für Anästhesiologie und Intensivtherapie - Universitätsklinikum Leipzig AöR | |
| Leipzig, Germany, 04103 | |
| Klinik und Poliklinik für Anästhesiologie und operative Intensivmedizin der Westf. Wilhelms-Universität | |
| Münster, Germany, 48149 | |
| Universitätsklinikum Tübingen, Klinik für Anästhesiologie und Intensivmedizin | |
| Tübingen, Germany, 72076 | |
Sponsors and Collaborators
Fresenius Kabi
Investigators
| Study Chair: | Bertrand Guidet, Prof., MD | Hôpital St Antoine, Réanimation Médicale |
More Information
No publications provided
| Responsible Party: | Fresenius Kabi |
| ClinicalTrials.gov Identifier: | NCT00464204 History of Changes |
| Other Study ID Numbers: | 06-HE06-01, 2006-004350-25 |
| Study First Received: | April 20, 2007 |
| Results First Received: | May 30, 2011 |
| Last Updated: | January 9, 2012 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) United States: Food and Drug Administration Germany: Federal Institute for Drugs and Medical Devices |
Additional relevant MeSH terms:
|
Sepsis Toxemia Infection Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes |
Hetastarch Plasma Substitutes Blood Substitutes Hematologic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013