NCT00799916

Brief Summary

Fluid resuscitation of severe sepsis may consist of natural or artificial colloids or crystalloids. There is no evidence-based support for one type of fluid over another. The investigators hypothesis is that fluid resuscitation with Voluven® is advantageous to normal saline solution to improve sublingual microcirculation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_3 sepsis

Timeline
Completed

Started Jan 2006

Typical duration for phase_3 sepsis

Geographic Reach
1 country

3 active sites

Status
completed

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

Study Start

First participant enrolled

January 1, 2006

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

November 28, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 1, 2008

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

September 15, 2009

Status Verified

September 1, 2009

Enrollment Period

3.6 years

First QC Date

November 28, 2008

Last Update Submit

September 14, 2009

Conditions

Sepsis

Keywords

SepsisFluid resuscitationVoluvenColloidsSaline solutionCrystalloidsSublingual microcirculation

Outcome Measures

Primary Outcomes (1)

  • Sublingual microcirculation

    24 hour

Secondary Outcomes (3)

  • Gases, hemoglobin and oxygen saturations

    24 hours

  • Electrolytes and lactate

    24 hours

  • Anion gap corrected to albumin

    24 hours

Study Arms (2)

Voluven

ACTIVE COMPARATOR

Resuscitation fluid: Voluven (R)

Drug: Resuscitation (Voluven)

Saline

ACTIVE COMPARATOR

Resuscitation fluid: Saline solution

Drug: Resuscitation (Saline)

Interventions

Resuscitation (Voluven)DRUG

Resuscitation aimed at venous oxygen saturation higher than 70%

Voluven
Resuscitation (Saline)DRUG

Resuscitation aimed at venous oxygen saturation higher than 70%

Saline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Severe sepsis

You may not qualify if:

  • Age of less than 18 years
  • Pregnancy, or the presence of an acute cerebral vascular event, acute coronary syndrome, acute pulmonary edema, status asthmatics
  • Cardiac dysrhythmias (as a primary diagnosis), contraindication to central venous catheterization, active gastrointestinal hemorrhage, seizure
  • Drug overdose, burn injury, trauma, a requirement for immediate surgery, uncured cancer (during chemotherapy
  • Immunosuppression (because of organ transplantation or systemic disease), do-not-resuscitate status, advanced directives restricting implementation of the protocol
  • Delayed admission to ICU from emergency department (more than 4 hours), or fluid resuscitation previous to ICU with more than 1,500 cc

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Clinica Bazterrica

Buenos Aires, 1425, Argentina

Location

Clínica Santa Isabel

Buenos Aires, 1425, Argentina

Location

Sanatorio Otamendi y Miroli

Buenos Aires, 1425, Argentina

Location

Related Publications (1)

  • Dubin A, Pozo MO, Casabella CA, Murias G, Palizas F Jr, Moseinco MC, Kanoore Edul VS, Palizas F, Estenssoro E, Ince C. Comparison of 6% hydroxyethyl starch 130/0.4 and saline solution for resuscitation of the microcirculation during the early goal-directed therapy of septic patients. J Crit Care. 2010 Dec;25(4):659.e1-8. doi: 10.1016/j.jcrc.2010.04.007. Epub 2010 Sep 1.

    PMID: 20813485DERIVED

MeSH Terms

Conditions

Sepsis

Interventions

ResuscitationHES 130-0.4Sodium Chloride

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Emergency TreatmentTherapeuticsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Arnaldo Dubin, MD

    Sanatorio Otamendi y Miroli

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 28, 2008

First Posted

December 1, 2008

Study Start

January 1, 2006

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

September 15, 2009

Record last verified: 2009-09

Locations

AR(3)