SepsisPhase 3NCT00799916
Saline Solution Versus Voluven®: A Controlled Study of Fluid Resuscitation in Severe Sepsis
A Phase 3 study testing Resuscitation (Voluven) and Resuscitation (Saline) in people with Sepsis, run by Universidad Nacional de La Plata at 3 sites in Argentina.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- What is being tested?
- Resuscitation (Voluven) and Resuscitation (Saline)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesArgentina
- Study dates
- Jan 2006to Aug 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Severe sepsis
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Argentina3 sites
Clinica Bazterrica
Buenos Aires, 1425
Clínica Santa Isabel
Buenos Aires, 1425
Sanatorio Otamendi y Miroli
Buenos Aires, 1425
About this study
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.
Read the detailed description
Shock is the failure of circulatory system to maintain adequate cellular perfusion. Septic shock is primarily a form of distributive shock and is characterized by ineffective tissue oxygen delivery and extraction associated with inappropriate peripheral vasodilation despite preserved or increased cardiac output. In sepsis, a complex interaction between pathologic vasodilation, relative and absolute hypovolemia, myocardial dysfunction, and altered blood flow distribution occurs due to the inflammatory response to infection. Even after the restoration of intravascular volume, microcirculatory abnormalities may persist and lead to maldistribution of cardiac output.
Notwithstanding the complexity of its pathophysiology and treatment, to maintain adequate organ perfusion is a main goal in the management of severe sepsis and septic shock. For this purpose, optimization of intravascular volume and preload is the more important step. Fluid challenge is a term used to describe the initial volume expansion period in which the response of the patient to fluid administration is carefully evaluated. During this process, large amounts of fluids may be administered over a short period of time under close monitoring to evaluate the patient's response and avoid the development of pulmonary edema. Fluid challenge should be given in all patients suspected of hypovolemia. Fluid resuscitation may consist of natural or artificial colloids or crystalloids. There is no evidence-based support for one type of fluid over another. As the volume of distribution is much larger for crystalloids than for colloids, resuscitation with crystalloids requires more fluid to achieve the same end points and might result in more edema. In addition, post-hoc analysis and experimental studies suggest that colloids might be superior to crystalloids, in terms of physiologic end-points, recruitment of the microcirculation and mortality.
- Conditions
- Sepsis
- Being tested
- Resuscitation (Voluven), Resuscitation (Saline)
- Keywords
- Sepsis, Fluid resuscitation, Voluven, Colloids, Saline solution, Crystalloids, Sublingual microcirculation
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resuscitation (Voluven)Drug
Resuscitation aimed at venous oxygen saturation higher than 70%
Resuscitation (Saline)Drug
Resuscitation aimed at venous oxygen saturation higher than 70%
| Study group | Role | What they receive |
|---|---|---|
| Voluven | Active comparator | Resuscitation fluid: Voluven (R) Receives: Drug: Resuscitation (Voluven) |
| Saline | Active comparator | Resuscitation fluid: Saline solution Receives: Drug: Resuscitation (Saline) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sublingual microcirculation
Measured: 24 hour
Secondary outcomes (3)
Gases, hemoglobin and oxygen saturations
Measured: 24 hours
Electrolytes and lactate
Measured: 24 hours
Anion gap corrected to albumin
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2008 (estimated)
- Study startJan 2006
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Nacional de La Plata
- Sponsor type
- University, hospital or other
- Collaborators
- Clínica Bazterrica, Sanatorio Otamendi y Miroli, National Agency for Scientific and Technological Promotion, Argentina
- Investigators
- Arnaldo Dubin, MD, Principal investigator, Sanatorio Otamendi y Miroli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00799916
- Sponsor's protocol ID
- GEM 001
- Status last verified
- Sep 2009
- First submitted
- 28 Nov 2008
- Last updated
- 15 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20813485
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Saline Solution Versus Voluven®: A Controlled Study of Fluid Resuscitation in Severe Sepsis
- ClinicalTrials.gov ID
- NCT00799916
- Acronym / sponsor ID
- GEM 001
- Conditions
- Sepsis
- Keywords
- Sepsis, Fluid resuscitation, Voluven, Colloids, Saline solution, Crystalloids, Sublingual microcirculation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universidad Nacional de La PlataUniversity, hospital or other
- Collaborators
- Clínica Bazterrica, Sanatorio Otamendi y Miroli, National Agency for Scientific and Technological Promotion, Argentina
- Study start
- Jan 2006
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 1 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Shock is the failure of circulatory system to maintain adequate cellular perfusion. Septic shock is primarily a form of distributive shock and is characterized by ineffective tissue oxygen delivery and extraction associated with inappropriate peripheral vasodilation despite preserved or increased cardiac output. In sepsis, a complex interaction between pathologic vasodilation, relative and absolute hypovolemia, myocardial dysfunction, and altered blood flow distribution occurs due to the inflammatory response to infection. Even after the restoration of intravascular volume, microcirculatory abnormalities may persist and lead to maldistribution of cardiac output.
Notwithstanding the complexity of its pathophysiology and treatment, to maintain adequate organ perfusion is a main goal in the management of severe sepsis and septic shock. For this purpose, optimization of intravascular volume and preload is the more important step. Fluid challenge is a term used to describe the initial volume expansion period in which the response of the patient to fluid administration is carefully evaluated. During this process, large amounts of fluids may be administered over a short period of time under close monitoring to evaluate the patient's response and avoid the development of pulmonary edema. Fluid challenge should be given in all patients suspected of hypovolemia. Fluid resuscitation may consist of natural or artificial colloids or crystalloids. There is no evidence-based support for one type of fluid over another. As the volume of distribution is much larger for crystalloids than for colloids, resuscitation with crystalloids requires more fluid to achieve the same end points and might result in more edema. In addition, post-hoc analysis and experimental studies suggest that colloids might be superior to crystalloids, in terms of physiologic end-points, recruitment of the microcirculation and mortality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Voluven | Active comparator | Drug: Resuscitation (Voluven)Resuscitation fluid: Voluven (R) |
| Saline | Active comparator | Drug: Resuscitation (Saline)Resuscitation fluid: Saline solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Severe sepsis
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resuscitation (Voluven)Resuscitation aimed at venous oxygen saturation higher than 70% | Drug | Voluven |
| Resuscitation (Saline)Resuscitation aimed at venous oxygen saturation higher than 70% | Drug | Saline |
Primary outcome
Sublingual microcirculation
Time frame: 24 hour
3 secondary outcomes
Gases, hemoglobin and oxygen saturations
Time frame: 24 hours
Electrolytes and lactate
Time frame: 24 hours
Anion gap corrected to albumin
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2009.
- Derived from this study: PubMed 20813485Dubin 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.
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Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arnaldo Dubin, MD principal investigator
Sanatorio Otamendi y Miroli
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Resuscitation (Voluven) and Resuscitation (Saline) in people with Sepsis, run by Universidad Nacional de La Plata at 3 sites in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sublingual microcirculation (time frame: 24 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00799916, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2009.