Clinical trial NCT00464204: Effects of Voluven on Hemodynamics and Tolerability of Enteral Nutrition in Patients With Severe Sepsis
Official title: Effects of Voluven on Hemodynamics and Tolerability of Enteral Nutrition in Patients With Severe Sepsis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Sepsis
Lead sponsor: Fresenius Kabi
Sponsor class: INDUSTRY
First posted: 2007-04-23
Enrollment: 196
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Amount of Study Drug Required to Achieve Initial Hemodynamic Stabilization
timeFrame: until hemodynamic stabilization (up to 48 hours)
Secondary outcomes:
measure: Time From Start of Fluid Resuscitation With Study Drug to the Initial Hemodynamic Stabilization
timeFrame: until hemodynamic stabilization (up to 48 hours)
measure: Quantity of Study Drug in 4 Days
timeFrame: 4 days
measure: Time From Start of Study Drug to Start of Enteral Nutrition in the Subgroup of Patients Who Received Enteral Nutrition
timeFrame: Until start of enteral nutrition (up to 48 hours)
measure: Time From Start of Fluid Resuscitation With Study Drug to Start of Enteral Nutrition After Hemodynamic Stabilization
timeFrame: up to 48 hours
measure: Total Amount of Enteral Calories During the First Seven Days of Enteral Nutrition
timeFrame: 7 days
measure: Length of Stay in the Intensive Care Unit (ICU)
timeFrame: Until discharge from ICU (up to day 90)
measure: Length of Stay in the ICU
timeFrame: Until discharge from ICU (up to Day 90)
measure: Length of Stay in the Hospital
timeFrame: Until discharge from hospital (up to day 90)
measure: Area Under the Curve (AUC) of Sepsis-related Organ Failure Assessment (SOFA) Score Per Day From Screening to Day 4
timeFrame: From Screening to Day 4
Other outcomes:
measure: Mortality
timeFrame: From Screening to end of Follow-up
measure: Changes in Renal Function: 1. Acute Renal Failure (ARF) at Any Time After Screening
timeFrame: From screening to end of follow-up (up to day 90)
measure: Changes in Renal Function: 2. Acute Kidney Injury Network (AKIN) Classification
timeFrame: From screening to end of follow-up
measure: Changes in Renal Function: 3. Risk, Injury, Failure, Loss, End-stage Kidney Disease (RIFLE) Classification
timeFrame: From screening to end of follow-up
Locations:
city: Amiens
country: France
facility: Hôpital Sud, Unité de Réanimation Médicale
city: Avignon
country: France
facility: Centre Hospitalier d'Avignon, Service de Réanimation Polyvalente
city: Belfort
country: France
facility: Centre Hospitalier de Belfort-Montbéliard, Service de Réanimation et Maladies Infectieuses, Site de Belfort
city: Bicêtre
country: France
facility: CHU de Bicêtre, Dpt d'Anesthésie Réanimation Chir.
city: Bobigny
country: France
facility: Hôpital Avicenne, Service de Réanimation
city: Bourg-en-Bresse
country: France
facility: Centre Hospitalier Fleyriat, Service de Réanimation Polyvalente
city: Charleville-Mézières
country: France
facility: CH Manchester, Service de Réanimation Polyvalente
city: Corbeil-Essonnes
country: France
facility: CH Sud Francilien, Site Gilles de Corbeil, Réanimation Polyvalente
city: Dijon
country: France
facility: CHU de Dijon - Hôpital du Bocage Service de Réanimation Médicale
city: Meaux
country: France
facility: CH Meaux, Service de Réanimation
city: Metz
country: France
facility: Centre Hospitalier de Metz, Réa Polyvalente
city: Montpellier
country: France
facility: Hôpital Lapeyronie / CHU Montpellier, Département d'Anesthésie Réanimation
city: Nancy
country: France
facility: Hôpital Central, Service Anesthésie-Réanimation, Chirurgicale CHU
city: Nîmes
country: France
facility: CHU Nîmes, Service de Réanimation, Division Anesthésie-Réa Douleur Urgence, Groupe Hospitalo-Universitaire Caremeau,
city: Orléans
country: France
facility: Hôpital de la Source, Réanimation Polyvalente
city: Paris
country: France
facility: Hôpital St Louis, Département Anesthésie et Réanimation Chirurgicale
city: Paris
country: France
facility: Hôpital Saint-Joseph, Service de Réanimation Polyvalente
city: Paris
country: France
facility: Hôpital St Antoine, Réanimation Médicale
city: Roanne
country: France
facility: CH Roanne, Service de Réanimation
city: St. Germain en Laye
country: France
facility: CHI Poissy - St Germain en Laye, Site de St Germain en Laye
city: Strasbourg
country: France
facility: Hôpital Civil de Strasbourg, Service de Réanimation Médicale
city: Leipzig
country: Germany
facility: Klinik und Poliklinik für Anästhesiologie und Intensivtherapie - Universitätsklinikum Leipzig AöR
city: Münster
country: Germany
facility: Klinik und Poliklinik für Anästhesiologie und operative Intensivmedizin der Westf. Wilhelms-Universität
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen, Klinik für Anästhesiologie und Intensivmedizin
Study officials:
affiliation: Hôpital St Antoine, Réanimation Médicale
name: Bertrand Guidet, Prof., MD
role: STUDY_CHAIR
References:
citation: 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.