Effects of Voluven on Hemodynamics and Tolerability of Enteral Nutrition in Patients With Severe Sepsis (CRYSTMAS)
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ClinicalTrials.gov Identifier: NCT00464204 |
Recruitment Status :
Completed
First Posted : April 23, 2007
Results First Posted : August 2, 2011
Last Update Posted : January 11, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Sepsis | Drug: 6 % Hydroxyethylstarch 130/0.4 = "Voluven®" Drug: 0.9 % NaCl | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 196 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Effects of Voluven on Hemodynamics and Tolerability of Enteral Nutrition in Patients With Severe Sepsis |
Study Start Date : | July 2007 |
Actual Primary Completion Date : | May 2010 |
Actual Study Completion Date : | December 2010 |

Arm | Intervention/treatment |
---|---|
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. |
- Amount of Study Drug Required to Achieve Initial Hemodynamic Stabilization [ Time Frame: until hemodynamic stabilization (up to 48 hours) ]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.
- Time From Start of Fluid Resuscitation With Study Drug to the Initial Hemodynamic Stabilization [ Time Frame: until hemodynamic stabilization (up to 48 hours) ]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 ]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) ]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 ]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 ]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) ]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) ]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) ]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 ]
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).
- Mortality [ Time Frame: From Screening to end of Follow-up ]Mortality was reported for the time period from Screening until the end of follow-up.
- Changes in Renal Function: 1. Acute Renal Failure (ARF) at Any Time After Screening [ Time Frame: From screening to end of follow-up (up to day 90) ]Acute Renal Failure (ARF) was defined as a two fold increase in serum concentration over the value at screening at any time after screening.
- Changes in Renal Function: 2. Acute Kidney Injury Network (AKIN) Classification [ Time Frame: From screening to end of follow-up ]Acute Kidney Injury Network (AKIN) Classification in this study is based on serum creatinine values and renal replacement therapy, i.e. ignoring criteria based on urine output, as fulfilment of urine output criteria cannot be determined from the data collected in the study. AKIN ranges from stage 1 to stage 3 (worst outcome). Stages differ in serum creatinine increase. Stage 1: Increase ≥ 0.3mg/dL or ≥ 150%-200% from reference; Stage 2: Increase ≥ 200%-300% from reference; Stage 3: Increase >300% from reference with an acute increase of at least 0.5mg/dL or renal replacement therapy.
- Changes in Renal Function: 3. Risk, Injury, Failure, Loss, End-stage Kidney Disease (RIFLE) Classification [ Time Frame: From screening to end of follow-up ]
Risk, Injury, Failure, Loss, End-stage kidney disease (RIFLE) Classification in this study is based on serum creatinine values and renal replacement therapy, i.e. ignoring criteria based on urine output, as fulfilment of urine output criteria cannot be determined from the data collected in the study.
RIFLE comprises five categories: Risk (R), Injury (I), Failure (F), Loss (L), End-stage kidney disease (E) (worst outcome). R, I and F are based on increase in serum creatinine. L and E are based on administration of renal replacement therapy.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00464204

Study Chair: | Bertrand Guidet, Prof., MD | Hôpital St Antoine, Réanimation Médicale |
Responsible Party: | Fresenius Kabi |
ClinicalTrials.gov Identifier: | NCT00464204 |
Other Study ID Numbers: |
06-HE06-01 2006-004350-25 ( EudraCT Number ) |
First Posted: | April 23, 2007 Key Record Dates |
Results First Posted: | August 2, 2011 |
Last Update Posted: | January 11, 2012 |
Last Verified: | August 2011 |
Sepsis Toxemia Infection Systemic Inflammatory Response Syndrome Inflammation |
Pathologic Processes Hydroxyethyl Starch Derivatives Plasma Substitutes Blood Substitutes |