Trial · NCT00464204

Effects of Voluven on Hemodynamics and Tolerability of Enteral Nutrition in Patients With Severe Sepsis

NCT00464204, Phase 3, Completed, Fresenius Kabi; results first posted 2011-08-02

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Effects of Voluven on Hemodynamics and Tolerability of Enteral Nutrition in Patients With Severe Sepsis. Trials, record NCT00464204. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00464204

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Effects of Voluven on Hemodynamics and Tolerability of Enteral Nutrition in Patients With Severe Sepsis
NCT number: NCT00464204
Status: Completed
Phases: Phase 3
Enrollment: 196 participants, actual
Lead sponsor: Fresenius Kabi
Conditions: Sepsis
Interventions: 6 % Hydroxyethylstarch 130/0.4 = "Voluven®", 0.9 % NaCl
First posted: 2007-04-23
Last updated: 2012-01-11
Other registries' IDs: eudract:2006-004350-25
Results first posted: 2011-08-02

Source ClinicalTrials.gov

Registered outcomes14

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Amount of Study Drug Required to Achieve Initial Hemodynamic Stabilization	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.
Secondary	Time From Start of Fluid Resuscitation With Study Drug to the Initial Hemodynamic Stabilization	until hemodynamic stabilization (up to 48 hours)	Time from start of fluid resuscitation with study drug to the initial hemodynamic stabilization
Secondary	Quantity of Study Drug in 4 Days	4 days	Total quantity of study drug infused over four consecutive days in the ICU
Secondary	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.
Secondary	Time From Start of Fluid Resuscitation With Study Drug to Start of Enteral Nutrition After Hemodynamic Stabilization	up to 48 hours	Administration of enteral nutrition before initial hemodynamic stabilization was ignored in this analysis.
Secondary	Total Amount of Enteral Calories During the First Seven Days of Enteral Nutrition	7 days	This amount will be calculated from start of enteral nutrition until 7 am of day 8
Secondary	Length of Stay in the Intensive Care Unit (ICU)	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).
Secondary	Length of Stay in the ICU	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).
Secondary	Length of Stay in the Hospital	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).
Secondary	Area Under the Curve (AUC) of Sepsis-related Organ Failure Assessment (SOFA) Score Per Day From Screening to Day 4	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).

1 to 10 of 14Source ClinicalTrials.gov

See all 14 registered outcomes

Outcomes15

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Amount of Study Drug Required to Achieve Initial Hemodynamic Stabilization	until hemodynamic stabilization (up to 48 hours)	Full analysis set (FAS) = all randomized patients treated with study drug who reached hemodynamic stabilization.	Milliliter	MEAN
SECONDARY	Time From Start of Fluid Resuscitation With Study Drug to the Initial Hemodynamic Stabilization	until hemodynamic stabilization (up to 48 hours)	Full analysis set (FAS) = all randomized patients treated with study drug who reached hemodynamic stabilization	Hours	MEAN
SECONDARY	Quantity of Study Drug in 4 Days	4 days	Full analysis set (FAS) = all randomized patients treated with study drug who reached hemodynamic stabilization	Milliliter	MEAN
SECONDARY	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)	Full analysis set (FAS) = all randomized patients treated with study drug who reached hemodynamic stabilization	Hours	MEAN
SECONDARY	Time From Start of Fluid Resuscitation With Study Drug to Start of Enteral Nutrition After Hemodynamic Stabilization	up to 48 hours	Full analysis set (FAS) = all randomized patients treated with study drug who reached hemodynamic stabilization	Hours	MEAN
SECONDARY	Total Amount of Enteral Calories During the First Seven Days of Enteral Nutrition	7 days	Full analysis set (FAS) = all randomized patients treated with study drug who reached hemodynamic stabilization	kcal	MEAN
SECONDARY	Length of Stay in the Intensive Care Unit (ICU)	Until discharge from ICU (up to day 90)	Full analysis set (FAS) = all randomized patients treated with study drug who reached hemodynamic stabilization.~Calculated for patients who did not die before end of study of the individual patient	Days	MEAN
SECONDARY	Length of Stay in the ICU	Until discharge from ICU (up to Day 90)	Full analysis set (FAS) = all randomized patients treated with study drug who reached hemodynamic stabilization.~Imputed with the longest possible duration for patients who died before end of the study of the individual patient.	Days	MEAN
SECONDARY	Length of Stay in the Hospital	Until discharge from hospital (up to day 90)	Full analysis set (FAS) = all randomized patients treated with study drug who reached hemodynamic stabilization.~Calculated for patients who did not die before end of study of the individual patient.	Days	MEAN
SECONDARY	Length of Stay in the Hospital	Until discharge from hospital (up to Day 90)	Full analysis set (FAS) = all randomized patients treated with study drug who reached hemodynamic stabilization.~Imputed with the longest possible duration for patients who died before end of the study of the individual patient.	Days	MEAN

1 to 10 of 15Source ClinicalTrials.gov

See all 15 outcomes

Results by group48

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Amount of Study Drug Required to Achieve Initial Hemodynamic Stabilization	Voluven® Arm	1379	Standard Deviation 886	Milliliter
Amount of Study Drug Required to Achieve Initial Hemodynamic Stabilization	NaCl 0.9 % Arm	1709	Standard Deviation 1164	Milliliter
Time From Start of Fluid Resuscitation With Study Drug to the Initial Hemodynamic Stabilization	Voluven® Arm	11.8	Standard Deviation 10.1	Hours
Time From Start of Fluid Resuscitation With Study Drug to the Initial Hemodynamic Stabilization	NaCl 0.9 % Arm	14.3	Standard Deviation 11.1	Hours
Quantity of Study Drug in 4 Days	Voluven® Arm	2615	Standard Deviation 1499	Milliliter
Quantity of Study Drug in 4 Days	NaCl 0.9 % Arm	2788	Standard Deviation 1799	Milliliter
Time From Start of Study Drug to Start of Enteral Nutrition in the Subgroup of Patients Who Received Enteral Nutrition	Voluven® Arm	24.6	Standard Deviation 32.7	Hours
Time From Start of Study Drug to Start of Enteral Nutrition in the Subgroup of Patients Who Received Enteral Nutrition	NaCl 0.9 % Arm	26.9	Standard Deviation 33.8	Hours
Time From Start of Fluid Resuscitation With Study Drug to Start of Enteral Nutrition After Hemodynamic Stabilization	Voluven® Arm	25.9	Standard Deviation 32.1	Hours
Time From Start of Fluid Resuscitation With Study Drug to Start of Enteral Nutrition After Hemodynamic Stabilization	NaCl 0.9 % Arm	27.6	Standard Deviation 33.6	Hours

1 to 10 of 48Source ClinicalTrials.gov

See all 48 results by group

Participant flow14

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Voluven® Arm	100
Overall Study	STARTED	NaCl 0.9 % Arm	96
Overall Study	Completed Treatment	Voluven® Arm	81
Overall Study	Completed Treatment	NaCl 0.9 % Arm	83
Overall Study	Day 30 Follow-up Performed	Voluven® Arm	89
Overall Study	Day 30 Follow-up Performed	NaCl 0.9 % Arm	83
Overall Study	Day 90 Follow-up Performed	Voluven® Arm	69
Overall Study	Day 90 Follow-up Performed	NaCl 0.9 % Arm	74
Overall Study	Withdrawal Due to Discharge From ICU	Voluven® Arm	18
Overall Study	Withdrawal Due to Discharge From ICU	NaCl 0.9 % Arm	11

1 to 10 of 14Source ClinicalTrials.gov

See all 14 participant flow

Adverse events464

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Anaemia	Blood and lymphatic system disorders	Voluven® Arm	22	100
other	Anaemia	Blood and lymphatic system disorders	NaCl 0.9 % Arm	21	96
other	Anaemia of chronic disease	Blood and lymphatic system disorders	Voluven® Arm	1	100
other	Anaemia of chronic disease	Blood and lymphatic system disorders	NaCl 0.9 % Arm	0	96
other	Coagulopathy	Blood and lymphatic system disorders	Voluven® Arm	1	100
other	Coagulopathy	Blood and lymphatic system disorders	NaCl 0.9 % Arm	0	96
other	Disseminated intravascular coagulation	Blood and lymphatic system disorders	Voluven® Arm	3	100
other	Disseminated intravascular coagulation	Blood and lymphatic system disorders	NaCl 0.9 % Arm	4	96
other	Hypocoagulable state	Blood and lymphatic system disorders	Voluven® Arm	1	100
other	Hypocoagulable state	Blood and lymphatic system disorders	NaCl 0.9 % Arm	0	96

1 to 10 of 464Source ClinicalTrials.gov

See all 464 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Voluven® Arm
Total, all-cause mortality	NaCl 0.9 % Arm
Total, other adverse events	Voluven® Arm	99	100
Total, other adverse events	NaCl 0.9 % Arm	95	96
Total, serious adverse events	Voluven® Arm	53	100
Total, serious adverse events	NaCl 0.9 % Arm	44	96

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
22624531	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Voluven® Arm vs NaCl 0.9 % Arm: Changes in Renal Function: 1. Acute Renal Failure (ARF) at Any Time After Screening	Trial comparisons
Voluven® Arm vs NaCl 0.9 % Arm: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00464204

GET https://conductscience.org/api/trials/v1/NCT00464204/results?page=2

API reference For AI assistants